Clinical Research Staffing stock photo
July 30th, 2015

Apprentices Available

Apprentices available to build a fresh new pool of talent in Quality, Regulatory, Clinical and Medical roles for Food, Biotech, Pharmaceutical and Medical Devices. Our grants cover part of the cost of training and employing apprentices while they work toward an industry certification, typically one or two years.  We currently have two Read the rest of this entry »

April 8th, 2015

Risk Based Auditing Fundamentals

You are Invited to an Evening Meeting

 

Risk Based Auditing Fundamentals

    

Orange County Regulatory Affairs Discussion Group

 

Tuesday, April 21, 2015
4:00 – 7:00 pm

Read the rest of this entry »

October 17th, 2014

Regulatory Inspections and How to Manage Them

You are Invited to an Evening Meeting

Regulatory Inspections
and How to Manage Them   

 

Orange County Regulatory Affairs Discussion Group (OCRA) 

 

Wednesday, November 5, 2014 

5:30 – 9:00 pm 

Read the rest of this entry »

August 18th, 2014

Secrets to Success: Pre-Subs, 510(k)s, and FDB

Wednesday, September 10, 2014 Read the rest of this entry »

August 18th, 2014

Is it a Recall? Now what do we do?

Thursday, August 28, 2014
Noon – 5:30 pm   Read the rest of this entry »

May 7th, 2014

ASQ Orange Empire Monthly Dinner Meeting

Tuesday, May 13, 2014 5:15 PM – 9:00 PM Pacific Time Read the rest of this entry »

March 10th, 2014

Knowing the best practices in applied statistics

uesday, March 11, 2014     5:30pm to 8:30pm

The Southern California Discussion Group of the ASQ Biomedical Division in association with ASQ SFV section 706 presents: Read the rest of this entry »

March 10th, 2014

ASQ March 2014 Roundtable – Risk Based Environmental Monitoring (EM)ASQ Biomedical Division


This message is sent by the Southern California Discussion Group of the Biomedical Division of ASQ of the American Society for Quality as a benefit of your membership.

____________________________________________________________________

The Southern California Discussion Group of the ASQ Biomedical Division Presents:

Risk Based Environmental Monitoring (EM)  

How to use risk to ensure your EM Program is value added & efficient

           An Industry Roundtable Discussion   

                      

Tuesday, March 25, 2014
5:30pm to 8:30pm Read the rest of this entry »

October 16th, 2013

Risk Management

Orange County Regulatory Affairs Discussion Group

Thursday, November 14, 2013

Location:

Irvine Marriott

18000 Von Karman

Irvine, CA  92612

949-553-0100   Read the rest of this entry »

October 10th, 2013

Clinical Trials 101

Joint Meeting with San Diego Regulatory Affairs Network

(SDRAN)

and 

Orange County Regulatory Affairs Discussion Group

 

Wednesday, October 30, 2013   Read the rest of this entry »

September 16th, 2013

CRITICAL PROJECT EXECUTION: The Keys to Success

Wednesday, September 25th, 2013 from 5:30 PM to 8:30 PM (PDT)

Biosense Webster 15715 Arrow Highway, Irwindale, CA Read the rest of this entry »

August 16th, 2013

Quality Management Systems

presented by Marianne Silva

This meeting is appropriate for those people in the medical products, clinical laboratory and food products industries who are currently developing or wish to improve the compliance or effectiveness of their company’s Quality Management System.

REGISTER HERE

The presentation on August 20th will provide:

  • An introduction to Quality Management Systems
  • Regulatory references for Quality Management System requirements
  • Discussions will include the application of Quality Management Systems as they relate to biologics, medical device, the food and supplement industries and the clinical laboratory environment.

Agenda

  • 5:30 pm – Registration and Networking
  • 5:45 pm – Dinner
  • 6:00 pm – Welcome and Introduction
  • 6:15 pm – Speaker
  • 7:45 pm – Break
  • 8:00 pm – Q&A Session
  • 8:15 pm – Raffle and VOC Survey
  • 8:30 pm – Adjournment

*Dinner is included with registration

Marianne’s presentation will focus on Quality Management Systems, references for Quality Management System requirements, and how to apply Quality Management systems to biologics, medical devices, clinical laboratories, and the food and supplement industries.

Marianne Silva is the Manager of Quality, Regulatory and Compliance for the USC Clinical Laboratories, Keck Hospital of USC and USC Kenneth Norris Jr. Cancer Hospitals. Marianne has a Masters Degree in Medical Technology, Immunohematology and Education in coordination with her SBB (Specialist in Blood Bank) training over 35 years ago. She was the Compliance Officer for a licensed blood center, the Compliance Officer for the Division of Transfusion Medicine at UCLA Medical Center, and the Instructor for medical technology students, teaching at California State University, Los Angeles for almost 10 years. Marianne is a Certified Quality Auditor and has over 35 years of experience in the Transfusion Medicine environment with an emphasis on regulations, accreditation, quality systems and compliance issues. Marianne worked for AABB Consulting Services Division, providing quality and regulatory solutions to clients across the United States and Canada.

Marianne has published multiple articles and a text on Quality, and has provided presentations at the local, state, national and international levels.

 

May 15th, 2013

Manager of Regulatory Affairs, Orange County CA

Job Description
• Manage Regulatory Affairs activities to include, but not limited to:
o Canadian Regulatory Submissions
o International Regulatory Submissions Teams
o Emerging Market Regulatory Strategy
o Global Product Assessments and Approvals
o Product Development Teams
o Regulatory Guidance for
 Change Control
 Product Review Boards

Requirements
• BS degree minimum in life sciences, advanced degree preferred
• 8+ years of experience in medical device industry
• FDA and Global Regulation requirements for Medical Device product lifecycle
Please contact:
Lewie Casey
Talent Manager
Phone: 818-552-4173
Email: lcasey@medexecintl.com

May 15th, 2013

Director of Regulatory Affairs, Orange County CA

Job Description
• Direct Regulatory Affairs activities to include, but not limited to:
o Domestic and Global Regulatory Intelligence
o Regulatory Strategy
o Regulatory Communication
o Global Read the rest of this entry »

April 11th, 2013

2013 Workshop – Marketing of FDA Regulated Products

FDA Centers, FDA Los Angeles District Office and the Orange County Regulatory Affairs Discussion Group Present The 16th Annual FDA-OCRA Educational Conference

June 12-13, 2013

Irvine Marriott
18000 Von Karman Avenue, Irvine, CA 92612 (949) 553-0100

The FDA-OCRA Educational Conference is a unique event co-sponsored by the FDA and OCRA, that affords you maximum interaction with both Los Angeles District and Washington-based FDA personnel. Over the years, the collaborative efforts of FDA and OCRA have brought FDA and Industry staff together for this Educational Conference.

Who Should Attend
* Regulatory Affairs/Compliance
* Clinical Affairs/Auditors
* Legal Staff
* Quality Affairs/Quality Control
* Marketing & Advertising
* Product Development
* Consultants & Analysts
* Operations & Management
Keynote Address:
What Went Wrong?
Tales from FDA’s Office of Criminal Investigations (OCI)
Special Agent Keith Hadley, from FDA’s Office of Criminal Investigations, will discuss criminal aspects of non-compliance.

Plenary topics:
* Food & Drug Administration Initiatives for 2013 and “Hot” Topics:
An Agency Perspective
* FDA and FTC Guidance on Social Media:
Innovative Marketing v. Control
* Border Protection: What happens if Your Product is Imported or
There are Suspicious Imports?
* Inspection Mitigation: Avoiding Escalation
* Business Disruption & Resumption Planning After a Disaster:
Real Life Experience and Agency Expectations
* Federal and State Marketing: Sunshine Laws
* Q&A Panel Sessions with all Speakers

Three Separate Breakout Sessions:
1. Medical Devices & IVDs:
* CDRH Update: Hot Topics, Changing Guidance & Expectations,
Partnering: The MDIC Experience
* Federal and State Marketing: Sunshine Laws
* UDI: Implementation and Impact on Industry
* Clinical Trials for Medical Devices: Key Priorities and Activities
* Case for Quality: What are Responsibilities of
Manufacturers/Distributors and FDA’s Next Steps
2. Drugs/Biologics/OTC/Generics:
* Marketing Applications: FDA Review Practices and
Preparation of Global CMC Submissions
* Generic Drugs and Biosimilars Update
* Quality by Design: How Well does Pharma Meet
Deming’s 14 Points?
3. Food/ Dietary Supplements:
* CFSAN and Industry Update
* GMP Issues: Updates, Inspections, Recent Enforcement Activity
* Labeling and Claims
* Dietary Supplements Case Studies and Expert Panel Discussion

Register Online
Be sure to log on or create a new user profile before registering
http://www.ocra-dg.org/

SCHEDULE

Wednesday, June 12, 2013

7:00 – 8:00 am
Registration and Continental Breakfast

8:00 – 8:30 am
Opening Remarks by Conference Chairs and OCRA President
Alonza E. Cruse, B.S., District Director, FDA Los Angeles District
Regina O’Meara, Principal, Global IVD Regulatory Consulting
Ginger Clasby, VP Clinical & RA, Transcend Medical, Inc.
8:30 – 9:20 am
Keynote Address:
Real Life Stories from FDA’s Office of Criminal Investigations
Moderator:
Regina O’Meara, Principal, Global IVD Regulatory Consulting
Speaker:
Keith Hadley, Special Agent, FDA’s Office of Criminal Investigations (OCI)
Agent Hadley will discuss criminal aspects of non-compliance.

9:20 – 9:45 am
Break

9:45 – 10:45 am
Food & Drug Administration Initiatives for 2013 & “Hot” Topics:
An Agency Perspective
Moderator:
Alonza E. Cruse, B.S., District Director, FDA Los Angeles District
Speaker:
FDA Speaker Invited
10:45 – 11:45 am
FDA and FTC Guidance on Social Media:
Innovative Marketing v. Control
Moderator:
Michael J. Wagner, Esq., Regulatory Counsel, Focus Diagnostics
Speakers:
FDA Speaker Invited
Eric Goldman, Professor of Law and Director of the High Tech
Law Institute, Santa Clara Law School
This session will cover the following on social media:
* Agency current expectations
* Status of FDA Guidance
* Tools available to monitor social media
* Online Accountability for manufacturers, distributors and packers
* Using Links on the Internet
11:45 am – 1:00 pm
Lunch

1:00 – 2:00 pm
Inspection Mitigation: Avoiding Escalation
Moderator:
Yasamin Ameri, RAC, Consultant, Quest International Consulting
Speakers:
Dr. Raymond W. Brullo, DPM, FAPWCA, Compliance Officer
FDA Los Angeles District
Jack Sorokin, Esq. Invited
This session will cover the following:
* Addressing potential findings during an inspection
* Responding to inspectional findings
* Meeting with the District
* Estimating Agency expectations and meeting them
* Not all inspections go smoothly and the are different levels of findings
* How does a firm ensure that corrective actions meet the FDA expectations and what are some practical tips for avoiding enforcement escalations

2:00 – 3:00 pm
Business Disruption & Resumption Planning After a Disaster:
Real-Life Experience and Agency Expectations
Moderators:
Esther Y. Kim, Esq, Director of Legal/Compliance, Pharmavite LLC
Del Stagg, PhD, Regulatory Affairs and Quality Consultant
Speakers:
Tanya Malais, National Emergency Response Coordinator, FDA
Robert Takemura, Partner, MLC & Associates, Inc.
This session will cover:
* Identifying potential disasters
* Business impacts following a disaster
* FDA expectations after a disaster

3:00 – 3:15 pm
Break

3:15 – 4:15 pm
Border Protection – What Happens if Your Product is Imported or There are Suspicious Imports?
Moderator:
Linda Hartley, Program Support Specialist, FDA Los Angeles District
Speaker:
Dan Solis, Director of Import Operations, FDA Los Angeles District

4:15 – 5:00 pm
End of Day Open Panel Discussion with All Speakers
Moderator:
James R. Lusk, RAC, Principal, Quality Systems International
5:00 – 8:00 pm
After Conference Reception
OCRA’s Member Appreciation Night
All attendees invited at no additional cost
Click Here to Download the Registration Form

SCHEDULE
Thursday, June 13, 2013
7:00 – 7:50 am
Networking Breakfast
Attendees will be broken into interest groups to discuss and strategize current industry challenges. We will have separate tables for the following groups:

* Medical Devices
* IVDs
* Drugs and Biologics
* Dietary Supplements

Note: The remainder of the day will be breakout sessions. There are three tracks to choose from:
Medical Devices and IVDs
Drugs, Biologics, OTC and Generics
Food and Dietary Supplements

Medical Devices and IVD
Breakout Sessions
8:00 – 9:15 am
Session #1: CDRH Update
Speakers:
FDA Speaker Invited
Mark DuVal, JD, President, DuVal & Associates
* Hot Topics
* Changing Guidance and Expectations
* Partnering: The Medical Device Consortium Experience

9:15 – 10:30 am
Session #2: Federal and State Marketing: Sunshine Laws
Moderator:
Elaine Messa, Director, Medical Device Quality Systems
Industry Speakers Invited
* What are Sunshine Laws?
* Reporting responsibilities of manufacturers
* Elements of marketing compliance plan
* What about the future and federal pre-emption?
* Covers marketing, sales and distribution
* Q & A
10:30 – 10:45 am
Break

10:45 am – 12:15 pm
Session #3: UDI (Unique Device Identifier):
Implementation and Impact on Industry
Moderator:
James “Rusty” Lusk, Principal, Quality Systems International
Speakers:
FDA Speaker Invited
Dawn Fowler, Sr. Manager of Global Labeling/Document Control,
Endologix
Everything you ever wanted to know, and more, about UDI
We know that:
* Not all suppliers are the same
* Not all manufacturers are the same
* Not all users are the same
* Not all points of use are the same

We also know that all the above and more, have a need to share the identical information across their points of contact. The UDI is the glue that binds the information into a format that is universally understandable and instantly available at all there interfaces.
Different needs may have different approaches:
* I have one high product. Why all the fuss?
* I have a bazillion sku’s- where do I start?

This session will cover:
* Format Options- why chose one over the other?
* General structure requirements
* Equipment Options
* Implementation successes and pitfalls
* Big Company versus Small Company approaches
* How much will this cost?

12:15 – 1:00 pm
Lunch

1:00 – 3:00 pm
Session #4: Clinical Trials for Medical Devices
Moderators:
Ginger Clasby, VP Clinical & RA, Transcend Medical, Inc.
Terrie Hopton, Mgr, Business Development, Promedica International
Speakers:
James R. Fleckenstein, Investigator, FDA, Los Angeles District
Christian Burns, Director, Clinical Operations & Marketing, ClinEdge
Lucinda Marinus, Clinical Data, Manager, Transcend Medical
Jodi Aiken, VP, Global Clinical Affairs, Transcather Heart Valve
Therapy, Edwards Life Sciences
In this session, we will discuss several key priorities and activities associated with planning and implementing medical device clinical trials, with an emphasis on:
* Unique considerations associated with finding and recruiting study subjects to participate in medical device clinical trials
* Considerations and best practices for collecting and analyzing clinical study data
* Risk-based monitoring of study progress and conformance with regulatory requirements

3:00 – 3:15 pm
Break

3:15 – 4:15 pm
Session #5: Case for Quality
Moderator: Eri Hirumi, RAC, Regulatory Affairs Manager, Beckman Coulter, Inc.
Speakers: FDA Speaker Invited
This session will cover:
* Background of the Initiative
* Why it’s important
* What are responsibilities of manufacturers and distributors?
* FDA’s next steps
Drugs, Biologics, OTC and Generics Breakout Sessions

8:00 – 9:30 am
Session #1: Marketing Applications: FDA Review Practices and Preparation of Global CMC Submissions
Moderator:
Cindy Fisher, PhD, RAC, Associate Director, Regulatory Affairs, Vical
Speakers:
Industry Speaker Invited
What does FDA look for in marketing applications? A CBER review team member will provide insights into how FDA reviews marketing applications and helpful hints on making your application process run more smoothly.
In today’s global economy, many companies are filing products internationally. With varying in-country requirements and varying IP protection around the world, what are the best practices for managing global CMC submissions?
This session is sponsored by the OCRA CMC Discussion Group.

9:30 – 9:45 am
Break

9:45 am – 12:00 pm
Session #2: Generic Drugs and Biosimilars Update
Moderator:
Michael A. Swit, Esq., Special Counsel, Duane Morris, LLP
Speakers:
FDA Speaker Invited
With the enactment of the Generic Drug User Fee Act (GDUFA), FDA’s Office of Generic Drugs (OGD) may finally have the resources it needs to address both the significant backlog in pending applications and the timelines for approval of generic drug applications. This session will explore how OGD is marshaling these new resources and dealing with other key issues evolving in the generic drug approval process, including citizen petitions challenging generic approval standards and a potential regulation that would impose new pharmacovigilance duties and labeling revision obligations on generic manufacturers. For anyone concerned with generic drugs, whether from a brand or generic perspective, this is an essential session.

12:00 – 1:00 pm
Lunch

1:00 – 4:15 pm
Session #3: Quality by Design (QbD): How Well Does Pharma Meet Deming’s 14 Points?
Moderator:
Ali M. Afnan, PhD, President, Step Change Pharma, Inc.
Speakers:
FDA Speaker Invited
Kevin R. Cahill, Executive Director, The W. Edwards Deming Institute
Ali M. Afnan, PhD, President, Step Change Pharma, Inc.
Michelle Howard-Sparks, Associate Director of Solid Formulations
Millenium Pharmaceuticals Invited
This session will delve into the application of W. Edwards Deming’s 14 Points for Management to the pharmaceutical industry. In the first half of the session, Kevin Cahill, VP of The Deming Institute and Deming’s grandson, will provide a primer on the Deming’s 14 Points and the philosophy behind them. The second speaker, Ali Afnan, will discuss the applicability and incorporation of Deming’s total quality management approach in the pharmaceutical arena.
In the second half of the session, the FDA will examine the application of statistical quality control techniques to ensure the quality of pharmaceutical products. Finally, an industry speaker will examine the incorporation of Deming’s concepts to the management of development and risk in a pharmaceutical setting.

2:30 – 2:45 pm
Break

QbD Session continues after the break.
Food/Dietary Supplements
Breakout Sessions

8:00 – 10:00 am
Session #1: CFSAN and Industry Update
Moderator:
Vicki Whitsitt, Mgr, Scientific/Regulatory Affairs,
Natural Products Association
Speakers:
FDA Speaker Invited
Cara Welch, PhD, VP Scientific/RA Natural Products Association
Michael McGuffin, President, American Herbal Products
Association (AHPA) Invited
This session will feature an update from FDA on industry hot topics their current priorities and hear from two industry associations address the challenges facing dietary supplement companies both on Capitol Hill and on the regulatory front. While GMPs continue to be in the forefront, it’s not just about GMPs – speakers will also touch topics such as adverse event reporting, the draft NDI guidance, FSMA proposed rules, import/exports, adulterated ingredients, etc.

10:00 – 10:15 am
Break

10:15 – 11:45 am
Session #2: GMP Issues
Moderator:
Timothy Stewart, PhD, Consultant, QSD Consulting Group
Speakers:
FDA Speaker Invited
Cindy Beehner, President, QSD Consulting
This session features an update from FDA on its recent GMP-related enforcement activities and inspection findings and insight from an industry consultant about addressing the most common problems and how to effectively respond to 483 observations.

11:45 am – 12:45 pm
Lunch

12:45 – 2:30 pm
Session #3: Labeling and Claims
Speakers:
FDA Speaker Invited
Industry Attorney Invited
Supplement labels and claims continue to be a concern to FDA and a source of numerous warning letters. Hear from FDA about the basic regulatory requirements for product labeling and claims for your products. The industry attorney will discuss how to properly position your product in the marketplace, discuss Prop 65 issues, and discuss how product labeling is causing companies to become part of class action suits.

2:30 – 2:45 pm
Break

2:45 – 4:15 pm
Session #4: Dietary Supplements Case Studies
and Expert Panel Discussion
All Speakers Are Asked To Join the End of Day Panel
This session will begin with a group activity of case studies on various scenarios related to current industry issues. The individual groups will share summaries of their case studies, and then it will be open to discussion from the group as a whole and input from the expert panel of speakers.

About OCRA
OCRA, Orange County Regulatory Affairs Discussion Group, is a non-profit volunteer organization composed of Regulatory Affairs professionals from the Southern California area who are interested in participating in educational programs and networking with one another. Our membership includes individuals who work in Life Sciences industries such as medical devices, pharmaceuticals, biologics, IVD, dietary supplement, food and cosmetics.

OCRA has over 850 members representing more than 225 companies in Orange County and surrounding areas. Our members represent companies of all sizes and complexities.

OCRA meetings provide an educational forum and a means for the regulatory community to network. While our focus is regulatory in nature, our programs have also provided timely information for individuals involved in Engineering (software validation and product development), Marketing (advertising and labeling), Quality (Quality System Regulation), and other related fields.

Gift Bag Giveaways and Sponsorships Available
Contact Kimberly Syre at ksyre@cox.net to inquire about sponsorship opportunities.

REGISTRATION INFORMATION
The 16th Annual FDA-OCRA Educational Conference
Applying Regulatory Science to the Marketing of FDA Regulated Products
June 12-13, 2013 at Irvine Marriott
For an Immediate Receipt, Please Use the On-Line or PayPal Option
http://www.ocra-dg.org/
REGISTRATION RATE
$ 725 OCRA Members
$ 775 Non-members (includes OCRA membership for one year)
$ 475 FDA/Government/Students*

ONE DAY RATE:
$ 425 OCRA Members
$ 475 Non-members (includes OCRA membership for one year)
$275 FDA/Government/Students*

* Student Rate is for individuals enrolled full time in a Regulatory or Quality related academic program at an accredited institution. The Student Rate does not apply to working professionals taking one or two courses on the side. Student ID and copy of current class schedule are required to register at this rate. Final eligibility determined by OCRA.

INSTRUCTIONS TO REGISTER ONLINE:
Log onto the OCRA website (http://www.ocra-dg.org/) with your username and password OR Create a new account by selecting “Register” on the top right hand side. If you are not an OCRA Member, it will ask you to join. Please keep in mind that to attend any OCRA meeting, we require you to become a Member.

April 2nd, 2013

Building and Maintaining Quality in Clinical Trial Performance

FDA Inspections of Clinical Research Sites and Sponsors

Building and Maintaining Quality in Clinical Trial Performance

Wednesday, April 10, 2013

5:30 – 8:30 pm

Location:   

AMO Headquarters
1700 East St. Andrews Place
Santa Ana, CA 92705-4933

Program Managers:

Terrie Hopton, Manager, Business Development and Special Projects, Promedica International

Helene Spencer, Consultant, ClinReg Consulting Services, Inc.

Host: Tammy Vu, Regulatory Affairs Specialist, Global RA, Abbott Medical Optics Inc.

Schedule

5:30 – 6:30 pm      Registration and Networking Dinner

6:30 – 7:30 pm     

What FDA Looks for in Clinical Study Site Inspections

Speaker: Gene Arcy, Consumer Safety Officer and BIMO Inspector, FDA Los Angeles District

 

7:30 – 8:30 pm     

What Sponsors (and Sites) Should Be Doing to Assure Study Protocol and GCP Compliance

Speaker: Ginger Clasby, Vice President, Clinical & Regulatory Affairs, Transcend Medical Inc.

 

Synopsis:

The implementation and maintenance of high quality clinical programs is an expensive, time-consuming and hugely important activity for sponsors who will need study results for regulatory submissions or market expansion. Key factors include:

*   A variety of personnel, logistical and regulatory elements must be budgeted for, contracted and coordinated efficiently.

*   A thoughtful plan should be in place to recruit qualified study participations in a timely manner – and to keep them actively involved throughout their participation in the study.

*   Clinical data supporting study objectives must be captured and maintained in a manner that protects data integrity and is relatively simple for study sites to do.

*   A system should be in place to promptly and thoroughly evaluate and report safety events, as appropriate.

*   And, depending on the nature and duration of the study, there are the challenges of “cutting in” protocol modifications, managing changes in data capture requirements, study team turnover and the accompanying overall “study fatigue” experienced by study sites and sponsor work teams.

At this meeting, using a combination of didactic and case studies presentations, we will discuss best practices for clinical study start-up and ongoing implementation to ensure study quality and review how FDA inspectors confirm the adequacy of GCP and protocol compliance.

About the Speakers:

Gene Arcy has been an FDA Consumer Safety Officer for 13 years. HIs experience includes:

·    Biologics Specialist

·    HCT/Ps Inspection Program Monitor  (HCT/Ps = Human Cellular and Tissue-Based Products) for Los Angeles District (HCT/Ps regulated by CBER = Center for Biologics Evaluation and Research)

·    Medical Device Inspection Program Monitor (CBER approved/cleared devices only) for Los Angeles District

·    Also specialize in the inspection of tissue-based devices that have been cleared by CDRH, and conduct routine inspections of other non-tissue based medical devices (Not sure how you want to word this).

·    Performed Biomedical Monitoring (BIMO) inspections of clinical investigators under the GCPs to a large extent, and performed inspections of sponsor and  IRBs.  Also experienced conducting GLP inspections.

Gene has a M.S. in Quality Assurance-Manufacturing and served on Air Force active duty and Retired from the Air Force National Guard – Clinical Laboratory Supervisor.

Ginger Clasby has worked in the field of regulated medical products for more than 25 years. Introduced to ophthalmic devices when she began employment with American Medical Optics (AMO) in 1978, she worked with the company for nine years in various capacities as the companyʼs business expanded: Biostatistician, Quality Assurance Manager, Production Manager – Intraocular Lenses (IOLs), Manufacturing Engineering Manager, Plant Manager and Product & Marketing Manager – IOLs.

Subsequent to her employment with AMO, she joined the ophthalmic surgical products divisionʼs executive team at Optical Radiation Corporation (ORC). There, as Vice President of Sales and Marketing, she was responsible for worldwide marketing and domestic sales of the divisionʼs Class III ophthalmic surgical products for five years.

In 1994, she joined Promedica International, a specialty contract research organization (CRO). As a pivotal executive in this privately-owned firm, she built the companyʼs clinical regulatory division from ground up, establishing the organization as a respected, major provider of clinical research services within the ophthalmic and medical device market sectors. During her 15 year tenure there, she served as Vice President, Clinical & Regulatory and also as Executive Vice President, Business Development.

Ginger joined Transcend Medical in 2009. As Vice President, Clinical & Regulatory Affairs, she is responsible for overseeing clinical operations and regulatory processes associated with implementation and ongoing management of the companyʼs pivotal US IDE trial as well as additional trials underway in Europe.

She holds the MS degree in Industrial Engineering from Arizona State University and BS degrees in Mathematics & Physics from Guilford College. She is the current President of OCRA and serves on the University of California-Irvine Extension Life Science Advisory Committee and the California State University Program for Education & Research in Biotechnology Advisory Board.

Cost:

$50 OCRA Members

$100 Non Members

    (includes one year Membership to OCRA)

$25 Student/Government Rate
FREE for Abbott Medical Optics Employees

OCRA REGISTRATION INSTRUCTIONS 

FDA Inspections of Clinical Research Sites and Sponsors

Wednesday, April 10, 2013

 

Registration fee includes dinner, free parking at AMO and access to electronic presentations (if approved by speakers for distribution).    

 

Be sure to log on or create a new user profile before registering: http://www.ocra-dg.org/

 

MULTIPLE REGISTRATIONS:

Our system is set up for one registration at a time. To register multiple people from your company, you can simplify the process by faxing us a cover page on your company letterhead listing the names of your attendees along with their title and email address and credit card payment. Please let us know if you want us to process your credit card or hold it until we receive a check.  

Click Here to Download Event Flyer 

SINGLE REGISTRATION: Log on to the OCRA Web site with your username and password or create a new user profile: http://www.ocra-dg.org/

Once you are logged on, click on “Register for a Meeting” on the right-hand side of the page. Next click on the meeting for which you would like to register, then follow the online instructions. You will receive an immediate confirmation.

If paying by personal or company check:  Please register online, then fax your credit card details on your company letterhead to 949-266-8461 to hold your spot. Mail your check made payable to OCRA to the following address:    

Orange County Regulatory Affairs Discussion Group

5319 University Dr., Suite 641, Irvine, CA 92612

Tel:     949-387-9046      Fax:     949-266-8461

Email: ksyre@cox.net

OCRA’s non-profit Federal Tax ID# 33-0630455

Payments and Cancellation Deadline:

For a refund, please cancel by emailing Kimberly Syre (ksyre@cox.net) by April 3, 2013. If you have reserved a space but do not attend, your payment MUST be remitted.

 

DRIVING DIRECTIONS:

Abbott Medical Optics (AMO)

1700 E. St. Andrew Place

Santa Ana, CA 92705

(714) 247-8200

Directions to AMO from Los Angeles International Airport:

– Exit the airport and follow the signs to 405 south (Long Beach)

– Continue on 405 for approximately 35 miles

– Take the 55 north and exit at Edinger Avenue

– Turn left onto Edinger

– Turn left on Lyon Street

– Turn left on St. Andrew Place and enter the first driveway on the right.

Directions to AMO from John Wayne, Orange County Airport:

– On exiting the airport, turn left onto MacArthur Boulevard

– Take the 55 north and exit at Edinger Avenue

– Turn left onto Edinger

– Turn left on Lyon Street

– Turn left on St. Andrew Place and enter the first driveway on the right.

It is recommended that you look up driving directions from your own starting point. 


Kimberly Syre
Attention To Detail
5319 University Dr., Suite 641
Irvine, CA  92612
Tel:    949-387-9046
Fax:    949-387-9047
Alt Fax:    949-266-8461
Email:    ksyre@cox.net

 

April 2nd, 2013

Continuous Improvement and Process Variations

 WEDNESDAY  April 17, 2013  
6 – 9 pm  

ASQ 702 San Gabriel Valley

Presents  

Continuous Improvement and Process Variations

Presented by Tarek Elneil

Any manufacturing process has five components sequentially connected in the following order: Supplier, Input, Process, Output, and Customer; in short, called SIPOC. Each component of the process can affect the next one in order. The Supplier can cause a problem in process input, which in results can affect the Customer at the end of the chain. The six components of the process input interact with each other and cause process variations. The process variations can due to common causes or special causes. Continuous Improvement goals are to reduce the common causes and to eliminate the special causes. When the process is under control 99.7% of the product will be within its established specifications, or statistically within + 3 Sigma. Six Sigma and Lean Manufacturing are tools to reduce the process non-conformance due to common cause; it can reduce the process non-conformance from 1350 ppm to be 0.001 ppm. Root Cause Analysis and Kepner Tregoe are tools used to reduce the non-conformance due to special causes. The main objective of non-conformance investigation is to select effective solutions and prevent the problem from recurring.

About the Speaker Tarek Elneil

Tarek Elneil is a Quality Consultant with over 14 years of experience as a change agent for Continuous Quality Improvement in the biotech, pharmaceutical, medical device, and dietary supplement industry; with an extensive experience in problem solving and root cause analysis.

Throughout his career, he has improved the quality systems, reduced the non-conformances and deviation cycle time. He has trained employees on problem solving and root cause analysis, reducing 75% of the non-conformance average cycle time. Tarek has managed process improvement projects, and led CAPA cross-functional teams to investigate quality failures utilizing the Six Sigma tools.

As a Certified Manager of Quality and Organizational Excellence, he has been the guest speaker on Continuous Improvement and Root Cause Analysis at ASQ and APICS events in Southern California. Tarek is an expert in systems analysis and database management with an emphasis on statistical analysis and performance metrics.

 

Location:

  Biosense Webster

15715 Arrow Highway

Irwindale, Ca  

 

6 – 6:30 dinner/networking

6:30 – 8:30 meeting

8:30 – 9 Section business/raffles  

 

Subway Sandwiches, chips, cookie, drink

(Registration closes at noon on day of event to allow for ordering of dinner options)

 

Members $10-, Non-members $15, Students $10 –   

 

(.3 R.U.s Awarded)

 

To encourage interaction, seating is limited to the first 40 registrants, so sign up soon!  

For more information or special order, contact:   Event Coordinator – Jean Flores at 909-322-2011

 

Contact for questions:
Randy Canfield, ASQ 702 Chair at Randy Canfield
March 14th, 2013

Delivering breakthrough product & process performance

The Southern California Discussion Group of the ASQBiomedical Division Presents:     

 

Design of Experiment:

Delivering breakthrough product & process performance

           An Industry Roundtable Discussion   

                       Read the rest of this entry »

March 8th, 2013

Delivering breakthrough product & process performance

The Southern California Discussion Group of the ASQ Biomedical Division Presents:     

 

Design of Experiment:

Delivering breakthrough product & process performance

           An Industry Roundtable Discussion   

                      

Thursday, March 21, 2013
5:30pm to 8:30pm

 

   

Topic:   

Utilizing a key six sigma tool, DOE to optimize product & process performance

Design of Experiments (DOE) is used to dramatically improve product and process innovation, effectiveness, and efficiency. DOE is the scientific approach used by researchers to build empirical mathematical models of product and process performance. These models are formulas that are used to optimize product and process performance while significantly reducing costs. DOE is considered the most powerful Six Sigma optimization tool and the Global Harmonization Task Force (GHTF) strongly encourages its use during medical device development.

Takeaways:

*  Understanding DOE (DOE VS One-Factor-at-a-Time VS Taguchi)

*  Learn how to create & analyze a factorial experiment

*  Learn how to optimize product and process performance while reducing variation and costs

Please bring your questions, experiences, and other commentary to make this a more valuable experience.

 

 

Expert: 

Ned Schneider     

Ned Schneider is a consultant and trainer with Advanced Response Engineering and has 20+ years medical device industry experience as an engineer and Director of Engineering working for several leading technology companies. Ned has compiled many Corporate Awards, Patents and ROIs over the course of his engineering career and has a B.S.M.E. & B.S. Industrial Engineering and Management. Ned provides engineering consulting and teaches ASQ Certification Refresher Classes for the Certified Six Sigma Black Belt and Certified Quality Engineering Programs. Also, for the past 6 years, he has taught Design of Experiments for both UC Irvine and UC San Diego through their Extension & Corporate Training Programs. He is an ASQ Certified Six Sigma Black Belt and Certified Quality Engineer with considerable expertise in the areas of product development, process development and automation.

 

 

To Register:

 http://www.acteva.com//booking.cfm?bevaid=235417

Registration:

Dinner & drinks will be provided.   

Seating is limited to the first 40 registrants, so sigh up soon!  

Registration closes at noon event day.  

Location:   Abbott Medical Optics 

                  1700 E. Saint Andrew Place, Santa Ana, CA  92705     

 

Member      

Early Registration $20- / After March 18th $25 

 

Non-member  

Early Registration $30- / After March 18th $35 

Students

Early Registration $15-  

(must show valid School ID at event registration table for entrance) 

 

Walkins $35- (cash only) if seating is available

 

 Click Here to Download the Event Flyer  

 

For more information, contact:

Tiffany Abrams at (714) 247-8572 or email:

Tiffany.Abrams@amo.abbott.com

 

As volunteers in a not-for-profit professional organization ASQ Biomedical, SCDG (Southern California Discussion Group) is committed to providing low cost high value events for biomedical professionals and the local community.  We are able to keep our costs low by utilizing a registration system that incurs minimal administrative overhead expenses and minimizes excess time and effort spent by our volunteers to bring you these events.  Please help us continue providing low cost quality programs to you by using the system that works well for us.  If you do not wish to use the registration system to preregister, you may attempt to register at the event, however seating is limited therefore entrance and/or food can not be guaranteed.  Also, due to the nature of the low pricing scheme and the registration system used, we are unable to perform refunds.

February 9th, 2013

Introduction to Minitab

 

ASQ 702 is Proud to Present “An Intro to Minitab”

Date: Saturday, March 9th

Time: 8:00am – 1 pm

Location: Biosense Webster
15715 Arrow Hwy., Irwindale, Ca 91706
Are you new to Minitab, or perhaps just need a little help in maneuvering thru the menus? Want to learn more of the capabilities that this powerful program has to offer? This may just be the perfect class for you.

And, this class will be presented by two of Section 702’s popular trainers–Larry Bartkus and Dan Gonzalez.

Space is limited to 40 participants only, so register early to hold your spot.

Special Group Rate Option now Available!

Register at http://www.acteva.com//booking.cfm?bevaid=235071

Description about the Course:
We will walk through many of the most commonly used statistical applications for Quality work and data analysis. Topics covered will include Data Distribution, Sampling and Sample Sizes, Hypothesis Testing, Control Charts, Gage R&R, Capability Studies and perhaps a little Design of Experiments. Some actual examples will be demonstrated for the use of these tools. The step-by-step approach will be shown through the use of Minitab software. Many difficult topics will seem relatively easy by the end of this session.

Three or four Take-away:
– We will know what to do with large data sets.
– How to determine if data is normally distributed.
– How to graph and interpret results from an analysis.
– Which tool to use for applying statistics to a project or process.

About the Trainers:
Larry was named So Cal Biomedical Discussion Group’s Speaker of the year for 2007-2008 and 2008-2009 for his informative, interactive, and always humorous presentations. He is a Six Sigma Master Black Belt and Certified Quality Engineer with over 35 years in the Quality Profession. Larry has extensive experience having held positions such as Supplier Quality Program Manager for ev3, Master Black Belt for J & J, and currently as Distinguished Engineer at Edwards Lifesciences in Irvine, Ca. Larry is highly active in the quality community having volunteered as speaker for The Society of Plastic Engineers, the Society of Manufacturing Engineers, APICS, USC, and ASQ. He is frequently called upon to be an instructor for CQE Refresher courses and has conducted seminars on subjects such as Six Sigma/Lean, Process Control, Statistical Sampling, Design of Experiments, etc.

Dan Gonzalez is the Master Black Belt for Biosense Webster, a Johnson & Johnson company. He has over eighteen years of Industrial Engineering, Manufacturing Engineering, and Quality Engineering experience that span the Aerospace, Electronics, Medical Device, Service Consulting, and Sheet Metal industries. He holds degrees from Cal Poly San Luis Obispo, the University of La Verne, and is in the process of completing his Doctoral dissertation at Pepperdine University. Dan has been guest speaker for various subjects at ASQ, Pepperdine University, Cal Poly San Luis Obispo, Cal Poly Pomona, the University of Southern California, University of La Verne, and Cal State LA.

 

January 29th, 2013

Current Trends in Good Manufacturing Practice

ASQ Orange Empire Presents….

Current Trends in Good Manufacturing Practice

This workshop is designed for anyone working in the FDA regulated industries and requires a comprehensive understanding of the basic concepts of Good Manufacturing Practice. FDA regulated industries includes pharmaceuticals, medical devices, blood products, biologics, dietary supplements,

cosmetics, and foods.

Some Workshop Highlights:

  • Identifying and overcoming the challenges associated with implementing effective written procedures
  • Developing recommendations to prevent audit observations
  • Conducting a mock GMP/QSR audit
  • An inside look at the FDA and how they operate
  • The why behind the GMP regulations. Exploring the intent of the regulations
  • How and why GMP makes Good Business Sense
  • And much more!

About the Speaker: David Markovitz

David Markovitz has over three decades of leadership and management experience in the health care industry. Having held positions as Manufacturing Laboratory Manager, Packaging and Filling Manager, Pilot Plant Manager, Manufacturing Engineer, Technical Training Manager, and Corporate Director of Education and Training, he has hands-on experience in effectively managing complexity with limited resources. David’s corporate experience was acquired at Nutrilite Products, SmithKline Beckman, Organon Diagnostics, and Ortho Diagnostics. David is the President of GMP Training Systems, an education, training, and consulting firm whose mission is to help organizations improve their productivity, quality, and long-term profitability by implementing strategies focused on innovation, continual improvement and optimization of work systems and processes throughout all levels in an organization.

David had the rare privilege of assisting Dr. W. Edwards Deming, the 20th century’s leading quality guru, in several of his famed Four-Day Seminars. David created and led the Deming Roundtable, an intensive year-long cooperative effort involving eight different organizations working to implement Deming’s teachings.

An internationally recognized and award winning speaker and workshop leader, David has been invited to present at conferences and meetings throughout the world. He is the recipient of the Gold Microphone Award (National Speaker Association) and the 2004 winner of the prestigious Connie Award for Professionalism on the Speaking Platform.

WHERE
Brandman University
16355 Laguna Canyon Road, Room #111, Irvine, California 92618USA

WHEN
February 22, 2013
8:30 AM -4:00 PM

Attire
Business Attire

Fees
ASQ Section 701 Member: $130, if registered by February 15th

Non-Section Member: $150, if registered by February 15th

Further Details:

View Event Details

Event Agenda

RSVP by Friday, February 15 for discounted pricing!

January 3rd, 2013

OCRA Supplements Update: What’s on the Horizon in 2013

Orange County Regulatory Affairs Discussion Group (OCRA)

Wednesday, January 9, 2013
12:30 pm – 5:00 pm
Location:
Irvine Marriott
18000 Von Karman, Irvine, CA 92612
949-553-0100

Program Managers:
Rogelio Rodriquez

Cameron B. Smith, J.D., Sr. Director, World Wide Regulatory, Government & Industry Affairs and Intellectual Property, Herbalife International of America

Vicki Whitsitt, Manager, Scientific and Regulatory Affairs, Natural Products Association

Schedule
12:30 – 1:00 p.m.
Registration

1:00 – 2:45 p.m.
Industry Update & What’s on the Horizon for 2013
Speakers:
Cara Welch, Ph.D., Vice President, Scientific & Regulatory Affairs, Natural Products Association (NPA)
and
Michael McGuffin, President, American Herbal Products Association (AHPA)
An industry update on regulatory activities that includes an update on current FDA activities including GMP inspections, GMP challenges with botanical dietary Ingredients & SAERs & a look at what’s ahead in 2013

2:45 – 3:00 p.m.
Break

3:00 – 3:45 p.m.
Testing and Laboratory Challenges
Speaker: Timothy Stewart, Ph.D., Consultant, QSD Consulting Group
Topics to Be Discussed:
1) FDA inspectors have developed and grown from entry level regulation curriculums. The harder questions are coming, how is your firm going to respond?
2) Specifications, raw material and finish product
3) Testing, raw material and finish product
4) Test appropriateness
5) Standards
6) Identification
7) Contamination
8) Sampling methods
9) Subset testing
10) What does that mean for your contract operations (manufacturing and laboratory)?
11) Qualified People
12) Corrective Action Reporting
13) OOS/OOT procedure
14) What does that mean for Quality Assurance and Regulatory Departments

3:45 – 4:30 p.m.
When to Call in the Experts
Speaker: Cameron Smith, J.D., Sr. Director, World Wide Regulatory, Government & Industry Affairs & Intellectual Property, Herbalife International of America

4:30 – 5:00 p.m.
Open Q&A with Speaker Panel
All presenters

Registration fee includes snacks, parking and access to electronic presentations (if approved by speakers for distribution).

About the Speakers
Michael McGuffin was honored in 2010 for over 20 years of dedicated service, having served as the President of the American Herbal Products Association (AHPA) and a member of the Board of Trustee’s for 10 years prior. He has been active in the herbal industry since 1974, having owned both retail and manufacturing businesses in this field.

A leading expert on dietary supplement regulation, Mr. McGuffin has been published in scholarly and scientific journals, including the Food and Drug Law Journal and Clinical Pharmacology & Therapeutics, and also wrote the highly-lauded publication AHPA’s Annotated Final Rule on Dietary Supplement cGMP (2007). Additionally, Mr. McGuffin served as Managing Editor of AHPA’s Botanical Safety Handbook (1997) and Herbs of Commerce, 2nd edition (2000). He speaks frequently on dietary supplement regulation in the U.S. and abroad.

Mr. McGuffin has represented the herbal industry at state and federal hearings on herbal regulatory issues. He has served as a member of the FDA’s Food Advisory Committee Working Group on Good Manufacturing Practices for Dietary Supplements (1998-99), the FDA’s Food Advisory Committee’s Dietary Supplements Subcommittee (2003-5) and currently serves on California’s Office of Environmental Health Hazard Analysis Food Warning Workgroup and the Advisory Board of the USC School of Pharmacy Regulatory Science Master’s Degree Program. He also serves on the boards of the American Herbal Pharmacopoeia, the American Association of Acupuncture and Oriental Medicine, and United Plant Savers.

Mr. McGuffin was awarded the Cliff Adler “Heart in Business” award in 1994 and the Nutrition Business Journal Award for Efforts on Behalf of Industry in 2004. Mr. McGuffin has been quoted in a variety of news publications such as the New York Times, the Washington Post, U.S. News & World Report and Newsweek and has made appearances on ABC’s Nightline, National Public Radio, and ABC Radio.

Cameron B. Smith, J.D., Senior Director, Regulatory, Government & Industry Affairs & Intellectual Property
Herbalife International of America
Cameron Smith has worked for Herbalife for eleven years and is one of the Company’s in-house attorneys. In addition to managing and protecting the Company’s intellectual property portfolio and handling a range of government-affairs responsibilities, he is the counsel of first resort for regulatory questions about foods, dietary supplements, and cosmetics, as well as product-related advertising and marketing issues. Admitted to practice in California, Louisiana, and Mississippi, Cameron earned his law degree at the University of Mississippi School of Law and his undergraduate degree at the University of Pennsylvania.

Timothy Stewart, Ph.D.,. QSD Consulting Group
Dr. Timothy Stewart is a retired professional athlete who became a scientist from University of Southern California. He has 10 years experience in oncology and chemistry laboratories using both modern instrumentation and classic compendia methods to bring better understanding of regulatory compliance to suppliers, manufacturers and marketers. Timothy has three years of experience with contract manufacturing of dietary supplements. Currently, he speaks, writes papers, audits, and works in a laboratory for the non-prescription drug, medical device, cosmetic, dietary supplement and food industries. He’s a consistent co-author for primary peer reviewed chemistry journals. In his spare time he can be found on the disc-golf course or riding waves in the ocean. You may view his profile at: http://www.linkedin.com/profile/view?id=48693551&trk=hb_tab_pro_top.

Cara Welch, Ph.D., Vice President, , Scientific & Regulatory Affairs Natural Products Association
Dr. Welch assists natural product industry members to implement policies in response to government initiatives in the regulatory and policy arena, and works with members of Congress and their staff, officials in the Food and Drug Administration (FDA), and other agencies whose actions have direct impact on the natural products industry. Additionally, she is responsible for advising association members on regulatory, safety, nutrition and health issues. Finally, she directs strategy development and provides guidance of the NPA Scientific and Regulatory programs, including the association’s Natural Certification for Personal Care and Home Care Products and Dietary Supplement GMP Certification.

Prior to joining the NPA, Dr. Welch studied at the department of Medicinal Chemistry at Rutgers University, under the direction of renowned plant biologist Dr. James E. Simon working on African botanicals and medicinal plants. She also studied with NPA Burton Kallman award winner Dr. Koji Nakanishi through the National Science Foundation’s Research Experience for Undergraduates (REU) award program. She earned her M.S. in Chemistry from the University of Iowa under Dr. James B. Gloer and her B.A. in Chemistry from Dordt College. She is a member of the American Chemical Society, American Society of Pharmacognosy and serves as a peer-reviewer for editorial boards.

Cost:
$135 OCRA Members
$185 Non Members
(includes OCRA Membership for one year)
$75 Student/Government Rate

REGISTRATION INSTRUCTIONS
Be sure to log on or create a new user profile before registering
http://www.ocra-dg.org/

Click Here to Download Registration Form for Fax Registrations

MULTIPLE REGISTRATIONS:
Our system is set up for one registration at a time. To register multiple people from your company, you can simplify the process by faxing us a cover page on your company letterhead listing the names of your attendees along with their title and email address.

SINGLE REGISTRATION:
Log on to the OCRA Web site with your username and password or create a new user profile:
http://www.ocra-dg.org/

Once you are logged on, click on “Register for a Meeting” on the right-hand side of the page. Next click on the meeting for which you would like to register, then follow the online instructions. You will receive an immediate confirmation.

If paying by personal or company check:
Please submit the online registration form. Mail your check made payable to OCRA to the following address:

Orange County Regulatory Affairs Discussion Group
5319 University Dr., Suite 641, Irvine, CA 92612
Tel: 949-387-9046
Fax: 949-266-8461 or 949-387-9047
Email: ksyre@cox.net

OCRA’s non-profit Federal Tax ID# 33-0630455

NOTE: We will ask for a credit card payment for any checks not received by the meeting date

Cancellation Deadline:
For a refund, please cancel by replying to this email by January 2, 2013.

If you have reserved a space but do not attend, your payment MUST be remitted.

DRIVING DIRECTIONS:
Irvine Marriott John Wayne Airport
18000 Von Karman Avenue, Irvine, CA 92612
Phone: 949-553-0100

From OC/John Wayne Airport:
Exit airport on Michelson Drive. Go straight to Von Karman Avenue and turn Left onto Von Karman Avenue. Turn Right onto Quartz and Left at the stop sign. The Marriott Hotel is on the left hand side.
From Long Beach Airport
or LAX – Los Angeles International Airport:
Take 405 South (San Diego Freeway). Exit Jamboree and turn Right off ramp. Turn Right onto Michelson Drive and Right onto Von Karman Avenue. Turn Right onto Quartz and Left at the stop sign. The Marriott Hotel is on the left hand side.

From Ontario International Airport:
Take 10 West (San Bernardino Freeway) to the 57 South (Orange Freeway). Take 57 South to the 5 South (Santa Ana Freeway). Take 5 South to the 55 South (Newport Beach Freeway) and then to 405 South (San Diego Freeway). Exit Jamboree, turn Right off ramp. Right onto Michelson Drive and Right onto Von Karman Avenue. Turn Right onto Quartz and Left at the stop sign. The Marriott Hotel is on the left hand side.
From Downtown Los Angeles:
Take 5 South (Santa Ana Freeway) to 55 South (Newport Beach Freeway). Take 55 South to 405 South (San Diego Freeway). Exit Jamboree and turn Right off the ramp. Turn Right onto Michelson Drive and Right onto Von Karman Avenue. Turn Right onto Quartz and Left at the stop sign. The Marriott Hotel is on the left hand side.
From San Diego:
Take 5 North (Santa Ana Freeway) to 405 North (San Diego Freeway). Exit Jamboree and turn Left off the ramp. Turn Right onto Michelson Drive and Right onto Von Karman Avenue. Turn Right onto Quartz and Left at the stop sign. The Marriott Hotel is on the left hand side.
From San Bernardino/Riverside:
Take 91 West (Riverside Freeway) to 55 South Freeway (Newport Beach Freeway). Take 55 south to 405 South Freeway (San Diego Freeway). Exit Jamboree Road, turn right off ramp. Turn Right onto Michelson Drive and Right onto Von Karman Avenue. Turn Right onto Quartz and Left at the stop sign. The Marriott Hotel is on the left hand side.

It is recommended that you look up driving directions from your own starting point.

Kimberly Syre
Attention To Detail
5319 University Dr., Suite 641
Irvine, CA 92612
Tel: 949-387-9046
Fax: 949-387-9047
Alt Fax: 949-266-8461
Email: ksyre@cox.net

November 14th, 2012

Technical and scientific skills aren’t enough in today’s workforce

 

Show Your Softer Side

by Rosemarie Christopher

As a whole, most experienced professionals value their technical mastery highly, and rightfully so. After all, look at the marvel of scientific achievement that is Curiosity, the robot the NASA Jet Propulsion Laboratory just put on Mars. Currently, it’s beaming back to its earth-bound creators terabytes of information that will propel mankind forward in many not-yet-imagined arenas of astronomy, space exploration, medicine, chemistry, microbiology, botany and zoology for decades to come.

It is the dedication to excellence in scientific and technical endeavors that makes everyday life on planet Earth richer, safer and physically less demanding than ever before in the history of humankind. Having recently undergone major surgery, I am astounded at how the combination of engineering and chemistry restored me to my normally high-speed functioning self in less than two weeks after an operation that in the past required a recovery time of four to six weeks.

Yet, as amazing is the technology and science that brought about a smoothly executed procedure and almost painless recovery, what is more significant was how the surgeon deftly combined his technical skills with his developed softer skills of empathy, intuition and in-person communication. This brings me to this month’s topic: how to power up our professional lives through the perfect blend of hard and soft skills.

Transformation

Until relatively recently, there has been little attention and importance placed on softer skills. In fact, it is difficult to quantify soft skills. But more companies are realizing that while an individual’s hard (technical or scientific) skills will move them ahead quickly, it is the dearth of soft skills that can derail an individual’s advancement.

If out of alignment with a department or organization, a lack of soft skills will result in the employee being sidelined or even eliminated. In part, this new focus on the balanced professional is due to the transformed workplace.

The pressures of globalization, swift and chaotic economic changes, exponential growth in technology advances and the presence of at least four generations with four different styles and philosophies of work have forced workers to accept some hard truths. Perhaps the most important is that while they cannot control external forces, to survive and thrive professionally, they must deal with diminishing personal power and productivity by proactively managing and directing these changes to their own benefit.

Empowerment

To direct their career destiny, experienced professionals must take preemptive action. Using their well-developed critical thinking skills, they must realize their final frontier is the mastery of the soft skills that ensure they gel with the increasingly diverse workforce.

Soft skills are abilities used to function effectively in the workplace. Among these are your unique work personality, behaviors (such as actions and interactions) and attitudes. Soft skills are not inborn. They are, as the term indicates, abilities and skills that can be acquired through observation, training, education, reading, experience, practice and other means.

There are empowerment tools to capitalize on the development and fine tuning of soft skills. Here are two suggestions that are useful no matter where you are in your career at the moment:

1. Create an online work personality profile. In my organization’s work of identifying and placing midsenior-level technical and scientific subject matter experts (SME), we have found that a dominance, influence, steadiness and compliance assessment helps us determine an individual’s dominant work style; their influencing behaviors; their steadiness, or response to work pace and consistency; and their response to procedures and compliance.

There are no right or wrong answers. The assessment helps our clients, our candidates and us determine a right fit for a position at a particular moment in time.

For example, if an individual’s work style is best-suited for constant new challenges, greater responsibility and leading their team with a high level of autonomy, we would assess whether a proposed position met all or at least most of that individual’s personal work style preferences and abilities. This might mean the individual would contribute at the highest level in a start-up or even as an SME consultant.

2. Get certified. One of the more enduring and valuable benefits of ASQ are its 17 certifications. Though being certified would certainly be considered a hard skill, having a certification in your industry engenders confidence in you and those you would benefit.

The implied message is you are strategic about your career, you recognize how to build trust, and you know how to make informed choices that benefit both internal (within the organization or consultancy) and external customers (clients). The express benefit to the certificate holder is increased ability to control his or her workplace destiny.


Rosemarie Christopher is President and CEO of MEIRxRS, a search firm for scientific and technical professionals in pharmaceutical, medical device, biologics, diagnostics and biotech companies in Glendale, CA. She has a master’s degree in communication management from the University of Southern California in Los Angeles. Christopher is an ASQ member and the chair of the ASQ Food, Drug and Cosmetic Division.

November 6th, 2012

The Supplier Did What?!

 

All too often we realize (a bit too late) that for some reason suppliers have an impact on our products and services. As it turns out, ensuring the consistent supply of “good” parts and services is key to any business. But what should we do? And how far do we go before our process becomes too draconian? In this discussion we will go over some of the main elements any purchasing/supplier controls process should have as well as discuss some of the many ways these elements can be implemented.

Wednesday, November 14th , 2012 at 5:30pm
Boston Scientific Neuromodulation Corporation
25155 Rye Canyon Loop Valencia, CA 91355 from 5:30pm to 8:00pm

Come and meet Michael Holcomb, Principal Supplier Quality Engineer with Boston Scientific Neuromodulation. Michael has 22 years of experience working in Quality for the nutritional supplement, drug/biotechnology, and medical device industries. He has worked in nearly every area in Quality, which includes 8 years in Supplier Quality. In that time he has seen just about every way a supplier quality system can be (and in some cases, shouldn’t be) implemented. He earned a Bachelor’s degree in Chemistry from California State University, Northridge. He is a Senior Member of ASQ and is an ASQ-certified MQ/OE.

October 16th, 2012

The Difference Between Success and Failure in the Medical Device Business

Selecting Alternative Regulatory Pathways to Market

 

Orange County Regulatory Affairs Discussion Group


You are Invited to an Evening Meeting

The Difference Between Success and Failure in the Medical Device Business: Selecting Alternative Regulatory Pathways to Market

 

Wednesday, Oct. 24, 2012


Time:  
       

6:00 pm – 8:00 pm  

  

Location:       

Alcon Laboratories
15800 Alton Pkwy
Irvine CA 92618

 

Presented by:

Evan L. Rosenfeld, MD JD FCLM 

Vice President for Medical and Scientific Affairs

Theorem Clinical Research

  

Program Manager: 

Christopher Swanson, Regulatory Affairs Specialist 

Advanced Sterilization Products 


Pricing: 

$50 OCRA Members 

$100 Non Members (includes OCRA Membership) 

$25 Students/Government
Free for Alcon Employees
(email Rob Fleming to be added to the list:
rob.fleming@yahoo.com)  

  

Synopsis of the Session:

The choice and availability of a more attractive, alternative regulatory pathway to the U.S. marketplace often can make the difference between a medical device manufacturer’s financial and market success or failure. Thus, a medical device sponsor’s essential business viability – or lack thereof – can depend directly on both the existence and the successful use of such an unconventional approach to FDA, especially for young companies in their early stages of business development.

In a 1997 law, the “de novo downclassification process” was created to assist companies to bring to market their new, novel, and by definition “Class III,” medical devices by allowing clearance under the much less burdensome 510(k) regulatory route, instead of having to go down the difficult route of premarket approval (“PMA”). Ultimately, the ability to submit a far simpler 510(k) premarket application rather than having to go the PMA route can reduce time to market entry by several years and decrease up-front monetary costs by literally hundreds of thousands of dollars. The de novo process allows FDA to more quickly and more simply clear a new device for sale on the U.S. market despite the nonexistence of a predicate device to which the “new” device might be found substantially equivalent and, thus, which ordinarily requires a PMA. The de novo process instead only requires the manufacturer to develop and implement certain, far less expensive “special controls” that better guide the consumer (including physicians and/or patients) that are aimed at enhancing overall patient safety and minimizing potential device-related dangers to the public.

The current presentation includes a brief historical overview of the de novo process and its evolution to present day, provides a summary of companies that have used the de novo process successfully, outlines the timeline for this process, discusses the changes to the de novo process that have been implemented most recently, and analyzes the benefits to and the challenges still facing the medical device industry’s use of the de novo downclassification route for product regulation and ultimate entry to the U.S. market. Also to be discussed are the Agency’s recent parallel activities to – on its own initiative – downclassify several device types, as support for FDA’s real moves to assist device manufacturers to move their innovative products more expeditiously through the market clearance process and onto the U.S. sales market.

About the Speaker:

Evan L. Rosenfeld, MD JD FCLM

Vice President for Medical and Scientific Affairs

Theorem Clinical Research, Dallas TX 

Dr. Rosenfeld is in charge of leading the company in its efforts to assist clients with their complex strategic clinical study design, implementation, completion, and review/interpretation of such trial results, from the various perspectives of:
*  Optimizing regulatory pathways; Outcomes of governmental reviews for market clearance or approval; Post−clearance/approval market positioning (relative to potential and/or existing competitors); Long−term safety outcomes and assessments; and Overall scientific/clinical rigor of the clinical studies under advisement.

*  Involvement at all stages of clinical trials, ranging from first−in−man and feasibility studies (to confirm and support continued product development efforts) to post−market trials (e.g., to support reimbursement activities, ongoing safety and efficacy monitoring, etc.).

*  Involvement in all company business units, with predominant focus on medical device clients, including those with device−drug combination and in vitro diagnostic (IVD) products.

*  Providing senior oversight on large or complex ongoing projects to ensure quality, delivery and ongoing client satisfaction; Identify client needs and develop creative solutions for projects, leveraging expertise, operational capabilities and technologies.

* Maintaining a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner. * Building thought leadership by participating in conferences, events, and client presentations. * Leading client meetings, conduct capabilities presentations, and leverage personal networks and Business Unit expertise.

He has his MD from Medical College of Virginia, his JD from University of Pennsylvania Law School and a BA in Biology from Harvard.

 Click here to download the registration form 

REGISTRATION INSTRUCTIONS 

  

For an immediate receipt and confirmation email, register on line at OCRA’s website, http://ocra-dg.org.

  

If paying by personal or company check:

Please submit the online registration form. Mail your check made payable to OCRA to the following address:

 

Orange County Regulatory Affairs Discussion Group

5319 University Dr., Suite 641, Irvine, CA 92612

Tel:     949-387-9046

Fax:     949-266-8461 or 949-387-9047

Email: ksyre@cox.net

 

OCRA’s non-profit Federal Tax ID# 33-0630455

 

NOTE: We will ask for a credit card payment for any checks not received by the meeting date

Cancellation Deadline:

For a refund, please cancel by replying to this email by October 17, 2012

 

If you have reserved a space but do not attend, your payment MUST be remitted.

 

DRIVING DIRECTIONS:

Alcon Laboratories 

15800 Alton Pkwy 

Irvine CA 92618

 

   

It is recommended that you look up driving directions from your own starting point.  

 


Directions from LA:
Take I-405 S to Exit 3 (in Irvine).  Take ramp right and follow signs for Shady Cyn Dr/Sand Cyn Ave.  Turn left onto Sand Canyon Ave.  Turn right onto Alton Pkwy.  Go 0.9 miles and arrive at 15800 Alton Pkwy, Irvine.  The last intersection is Telemetry.  (If you reach Banting, you’ve gone too far.)

Directions from San Diego:
Take I-5 N to Exit 94B.  Take ramp right and look for signs for Alton Pkwy. Turn left onto Alton Pkwy.  Make a u-turn at Telemetry and arrive 15800 Alton Pkwy. (If you reach Banting, you’ve gone too far.) 

  


Kimberly Syre
Attention To Detail
5319 University Dr., Suite 641
Irvine, CA 92612
Tel: 949-387-9046
Fax: 949-387-9047
Alt Fax: 949-266-8461
Email: ksyre@cox.net

 

October 15th, 2012

Medical Device Reporting Event: Inspections and Exemptions

Orange County Regulatory Affairs Discussion Group (OCRA)

Wednesday, November 7, 2012  

3:00 – 7:00 pm 


Location:   

Irvine Marriott

18000 Von Karman, Irvine, CA 92612 

949-553-0100

  Read the rest of this entry »

September 18th, 2012

SOCRA 21st Annual Conference September 21-23, 2012

 

Please join Rosemarie Christopher at the Society of Clinical Research Associates (SOCRA) 21st Annual Conference at the RIO All Suite Hotel in Las Vegas on September 21-23, 2012!

Clinical research professionals including investigators, research coordinators, research associates, project managers, consultants, educators, and administrators. Such participants may be affiliated with medical centers; cooperative research groups; research consortia; pharmaceutical, device, and biotechnology companies; contract research organizations; site management organizations; and independent research firms are all invited to attend. Register now!

  • Stop by MEIRxRS Exhibit Booth #10 for some goodies : )
  • Listen to Rosemarie Christopher present how to Manage a Multi-generational Workforce on Sunday, October 23rd at 10:10am
  • Earn Continuing Education Credit Hours
  • Network with over a thousand industry professionals in CRO, pharmaceutical, device and biotechnology companies
August 30th, 2012

Your Products and the Environment: Responsibilities & Stewardship

 

Sept. 12, 2012

5:00 pm – 8:00 pm

Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Training Center, Building #A
(entrance is off of Kraemer Blvd.)
Brea, CA 92822

Session Speakers:
Eri Hirumi, Group Manager of Corporate Regulatory Affairs, Beckman Coulter
Neal Langerman, PhD, Founder, Advanced Chemical Safety, Inc.
Vinay Goyal, Staff Product Environmental Specialist, Beckman Coulter

Your Products and the Environment: Responsibilities and Stewardship
Regulations are expanding the controls needed for the complete lifecycle of a product from the point of feasibility and raw materials to the disposal of the product and its wastes. This session covers challenges that regulatory affairs professionals face in today’s global environment. Regulations on raw materials, component parts, waste management, and chemical hazards all complicate medical device product lifecycles.

The targeted audience for this session is new and mid-level regulatory affairs specialists and environmental impact analysts who are responsible for a wide variety of products and need to understand the regulations that govern them. The impact of regulations on medical devices with electronic and chemical components will be the focus of this session. Effective cost and process management that links different regulations and products will be explored.

Pricing:
$50 OCRA Members
$100 Non Members (includes 2012 OCRA Membership)
$25 Students/Government
Free to Beckman Employees (email Rob Fleming to be added to the list: rob.fleming@yahoo.com)

Click here to download flyer and registration form or go to
http://library.constantcontact.com/download/get/file/1101994467498-389/OCRA+9-12-12+Meeting+Flyer.pdf

August 23rd, 2012

How To Get It Right The First Time

 

ASQ FDC SCDG Presents…

How To Get It Right The First Time

Thursday, August 23, 2012

5:30 p.m. – 8:30 p.m.

Baxter BioScience

1 Baxter Way #100, Thousand Oaks, CA 91362

Speaker & Host:  Mary Thorsness, Quality Manager – CAPA Division, Baxter BioScience

Mary graduated with a bachelor’s in Biology from the University of California at San Diego. Mary has been  with Baxter since 2005 as BioScience Division CAPA Manager and is responsible for the division CAPA program in 15+ sites throughout the US and Europe. Among her responsibilities, Mary is a certified Lead Investigator trainer responsible for training potential CAPA owners, approvers, and other trainers.  Prior to her current position at Baxter, was had extensive leadership experience in the biotechnology and medical device industries.

Abstract:
Which Data Streams You Should be Analyzing and How: There are an overwhelming number of data streams that can be analyzed and reported on. How do you sort the “essential” and focus on them? Do these reported data streams stay the same through the years, or do they evolve as your industry, company, and regulatory climate evolves?

This interactive session will identify which data streams you should use to gauge the health of your products and quality system and how to measure and report them in a way that will be understood by those who review them.

Takeaways

 Identify which data streams you should use to gauge the health of your products

– Identify which data streams you should use to gauge the health of your Quality system

– How to measure and report that data in a way that will be understood by those who review it

Speakers:  Niedre Heckman, Manager – Regulatory Affairs, Baxter BioScience and Kumari Devulapalle, Chemist – 3M

Niedre Heckman is a Quality Management professional with nearly two decades of hands on expertise in quality assurance, quality control, regulatory affairs and research and development. She is a process oriented leader with diversity of experience across medical products. She couples experience in quality systems and regulatory compliance with business acumen to develop strategic solutions that achieve organizational goals.

Currently, Niedre works in Regulatory Affairs at Baxter Healthcare Corporation.  Prior to this, she worked for 3M in Quality and in Regulatory Affairs positions.

Niedre is involved with the professional organizations ASQ and RAPS, where she holds the CQA and RAC certificates, respectively.  Niedre has an MS in Chemistry from UC Irvine and an MPH from UCLA.

Dr.  Kumari Devulapalle, has extensive experience in biochemistry and biotechnology both in academics and biopharmaceutical industry over 20 years. She has contributed to different NIH grants on enzyme kinetics and protein modeling  during her work at University of Southern California before she moved to Amgen analytical R & D on method development and validation for therapeutic biomolecules.

  • She has been working for the past 8 years at 3M Northridge, in quality control aspects of the biopharmaceuticals where she is leading the implementation of Six Sigma Lean projects. She is also known in adapting Right The First Time, analytical method improvements for product testing and release.

Abstract:

The majority of drug products are not discretionary and are often urgently needed.  Depending on the type of product, for example biologics, shelf-life and storage factor into the urgency of getting products to the customer.  Thus, there is a business need and responsibility to provide high quality products in a reasonable, and sometimes expedited, manner.  This presentation considers best practices for getting drug products to the customer in two areas: (1) Product release of pharmaceuticals from the Quality Assurance Unit, and (2) Global product registration enabling world-wide product accessibility to customers.  This audience interactive session will provide some dashboard metrics used to ensure processes for efficiently getting product to customers are tracked for continuous improvement.  The session will also bring awareness to some of the interesting details that can slow down the process.

Takeaways

  • General understand of metrics than can be applied to product release and product global expansion
  • Tools that can be implemented in a high-volume quality control laboratory
  • Awareness of how US compliance issues can slow down or stop global expansion

AGENDA

5:30 pm – Registration and Networking

5:45 pm – Dinner

6:00 pm – Welcome and Introductions

6:15 pm – Speaker:  Mary Thorsness

7:00 pm – Break

7:15 pm – Speakers:  Niedre Heckman and Kumari Devulapalle

8:00 pm – Q & A

8:15 pm – Evaluation and Raffle Drawings

8:30 pm – Adjournment

** Dinner is included with your registration. Register now at http://www.eventbrite.com/event/4024074114 

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