Clinical Research Staffing stock photo
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 »

October 17th, 2014

Precision  Medicine: A Medical Miracle or Ethical Nightmare?

The Precision Medicine presentation will explore the concept of precision medicine and how it impacts the conduct of oncology clinical trials, regulatory guidance, subject recruitment, and the protection of human subjects participating in research. Learn to recognize the therapeutic misconception and how it impacts patient, caregiver and investigator/physician in the decision-making process. We will debate the concept of “hope” and “autonomy” and how it impacts patient/caregiver decisions regarding clinical trials when research subject is facing a life-threatening disease.Date(s): Nov 6 2014, 05:00 PM to 07:00 PM

Location: CareFusion Corporation 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 »

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 »

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 »

May 15th, 2013

Sr. Manager/Director of Medical Education – Orange County, CA

As part of Global Medical Affairs, the Sr. Manager/Director of Medical Education is responsible for the successful execution of company Medical Affairs programs, including:

• Plan, manage and execute company’s New Customer Training and certification program worldwide, implement Staff and Surgeon training modules, develop strategies for training global field team.
• Associated to training and monitoring activities, the candidate will support implementation and execution of company’s podium and evidence plan, including:
o Planning, design, and execution of Read the rest of this entry »

May 7th, 2013

“Be in the know!”
Paper.li

Check out MEIRxRS’ new “quick read newspaper” and be in the know about what’s new in clinical research, regulatory affairs, quality assurance and medical affairs.

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

 

January 28th, 2013

Drug Shortages from the FDA, Industry, and Consumer Perspectives

Orange County Regulatory Affairs Discussion Group (OCRA)

 Friday, February 22, 2013

8:00 am to Noon

Free of Charge
OCRA Membership is Required

(Employees of Host Locations do not need to be Members)

Four Locations To Choose From:   

Amgen
One Amgen Center Drive; Thousand Oaks, CA  91320

Beckman Coulter

250 South Kraemer Boulevard; Brea, CA 92821

 Bausch + Lomb

50 Technology Drive; Irvine, CA 92618

 Ardea

4939 Directors Place; San Diego, CA 92121

 (see below for driving directions to each location)

 

Program Managers:

Damon Jones, Vice President, Director of Operations, McGuff Pharmaceuticals, Inc.

 Tania Hoffman, MSRS, Sr. Regulatory Affairs Manager,  Spectrum Pharmaceuticals, Inc.

 Ruchika Raval, RAC, Principal, Global Biopharmaceutical Regulations, Inc.

Synopsis

Disruptions in the supply of potentially life-saving medications have become a critical public health issue. Many factors lead to prescription drug shortages.  Manufacturers are often unable to provide timely and complete information on the causes and potential resolution of these shortages to the public, which often leads pharmacies and healthcare facilities to try to find ways of avoiding negative outcomes in the patients they treat. In 2011, President Barack Obama signed an Executive Order directing the Food and Drug Administration to take on a greater role in reducing and preventing drug shortages. In 2012, Title X of the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law, which lists the mandatory reporting requirements for manufacturers and provides FDA with important new authorities to help alleviate drug shortages. This program will look at drug shortages from the FDA, industry, and consumer perspectives and highlight efforts on all three fronts to manage this challenging issue.    

Speakers:

FDA Perspective 

Jeannie David, Program Management Officer, CDER Drug Shortage Program, FDA
(live from FDA Headquarters)

The speaker will discuss efforts underway at the FDA to address drug shortages, including interactions between the Agency and industry on manufacturing issues to maintain the safety and quality of medically necessary products while ensuring their continued availability.

 

Jeannie David, M.S. has been with the FDA since 2008. She is currently a Program Management Officer in the CDER Drug Shortage Program. She brings experience from her role as a Regulatory Health Project Manager in the CDER Office of New Drug Quality Assessment, the chemistry, manufacturing and controls (CMC) review division for new drug applications (NDAs), where she managed pre- and post-marketing applications, President’s Emergency Plan for AIDS Relief (PEPFAR) submissions, and presented a talk on Preparing for CMC Meetings with the FDA at the DIA 2012 Annual Meeting. Previously, Jeannie worked 7 years in the biopharmaceutical industry as a research scientist at Roche Palo Alto. She has a M.S. degree in neuroscience from the University of Wisconsin-Madison.  Ms. David will speak to us from Washington D.C.

 

Industry Perspective 

Scott McCarty, Risk Management Director, Amgen, Inc.
(Speaker will be at Amgen location) 

Scott McCarty has been with Amgen for 15 years, serving in a variety of roles in Operations and Quality Assurance. He is currently Director of Operations Risk Management, with responsibility for identification, characterization, and evaluation of risks to Amgen’s product supply chain. His prior Amgen experience includes leadership of a commercial product launch team and implementation of Amgen’s global change control system.

Prior to joining Amgen, Scott was a 20-year Navy fighter pilot, logging many aircraft carrier-based flight hours in F-4 and F-14 aircraft. Scott holds a bachelor’s degree in Economics from Stanford University, a master’s degree in Aeronautical Engineering from the Naval Postgraduate School, and the degree of Engineer in Aerospace Engineering from the University of Southern California.

 

Consumer Perspective

Speaker TBD
The speaker will discuss the effects of drug shortages on hospitals and patients.   

Schedule

8:00 – 8:45 am

Registration and Security Check In

Continental Breakfast 

 

8:45 – Noon  

Speaker Presentations 


REGISTRATION INSTRUCTIONS

  

For Amgen, Beckman Coulter and Ardea employees, please email Rob Fleming (rob.fleming@yahoo.com) with your name(s) and email addresses for each attendee.

All others please follow the instructions below. 

 

 

Be sure to log on and join or renew your OCRA Membership.  If you have not used our online system, you will need to create a new user profile before registering

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.

CLICK HERE TO DOWNLOAD EVENT FLYER

 

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    

 

 

DRIVING DIRECTIONS

 

Amgen

One Amgen Center Drive

Thousand Oaks, CA  91320

 

Note:  Please arrive at 8:00 am sharp as you need to be escorted to another building using Amgen’s shuttle.   

 

Please bring your photo ID for check in with Amgen security

Traveling Northbound on 405 and 101 Freeway

Take 405 Freeway North to 101 (Ventura) Freeway North.

Exit 47A Rancho Conejo Blvd.

Turn Right onto Ventu Park Road

Make a Left (before light at Pauling Dr.) into Building #37 parking lot.

Visitors to check in at Building #37 Lobby

Amgen Contact:  Amy Gonzales

Traveling Southbound on 101 Freeway

Traveling 101 S (towards Los Angeles)

Exit 47A, Borchard Rd. / Rancho Conejo Blvd.

Turn Left on Borchard Rd / Rancho Conejo Blvd

Continue to follow Rancho Conejo Blvd.

Turn Right on Ventu Park Road

Make a Left (before light at Pauling Dr.) into Building # 37 Parking Lot

Visitors to check in at Building #37 Lobby

Amgen Contact: Amy Gonzales

Beckman Coulter, Inc.

250 S. Kraemer Blvd.
Building #A
Brea, CA  92822

Directions from LA:
Take 405 S to 22 East.  Then take 57 N to Imperial Blvd.  Turn right onto  Imperial Blvd.  Go to the 5th Light and turn left onto Kraemer Blvd. Beckman Coulter will be on the right hand side.

Directions from San Diego:
Take 405 N to 55.  Then take 57 N to Imperial Blvd. Turn right at the end of the exit onto Imperial Blvd. Go to the 5th Light and turn left onto Kraemer Blvd.  Beckman Coulter will be on the right hand side.

Bausch + Lomb

50 Technology Drive

Irvine, CA 92618

 

From San Diego

Take 5 Freeway North

Exit at Alton Parkway (Exit 94B)

Turn Right onto Alton Parkway.

Take 1st Left  onto Technology Dr. W.

Bausch + Lomb will be on the Right.

 

From Long Beach

Take 405 Freeway South.

Exit at Irvine Center Drive (Exit 1C).

Turn Left onto Irvine Center Drive.

Turn Right onto Baranca Parkway.

Turn Left onto Technology Drive.

Bausch + Lomb will be on the Right.

Ardea

4939 Directors Place

San Diego, CA 92121

 

From San Diego Airport

Take 5 Freeway North.
Exit at Sorrento Valley Road (Exit 30).
Turn Left onto Roselle St.
Take the 1st Right onto Sorrento Valley Road.
Take the 2nd Right onto Vista Sorrento Pkwy.
Turn Left onto Directors Place.
Ardea will be on the Right.

From Oceanside
Take 5 Freeway South to 805 Freeway South.
Exit at Mira Mesa Blvd (Exit 27).
Turn Left onto Sorrento Valley Road.
Turn Left onto Vista Sorrento Pkwy.
Turn Right onto Directors Place.
Ardea will be on the Right.

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

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 »

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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