Clinical Research Staffing stock photo
May 16th, 2016

Lab Apprentices —Building a Workforce in a Tight Labor Market

Lab Apprentices are now available for CLIA, CAP and 17025 labs in California.
Lab apprentices pipet

“We are pleased with [our apprentice] who has been valuable to effectively upgrade our quality control programs, bring a youthful vision and spirit to our workforce, and help us develop a competent team for the future,” said Kevin Kimura of Red Shell Foods, Inc. in Sante Fe Springs, CA.

We are hoping to bring the same satisfaction our food companies have to labs.

Quality is important in all industries, but it is particularly important in Read the rest of this entry »

September 30th, 2015

Director of Quality GCP in San Diego, CA

We are searching for a Director of Quality GCP in San Diego, CA for a client in Phase III Trials. Candidates must have at least 4 years of experience in GCP to be considered.

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

Outsourcing 101

  

You are Invited to the Joint Fall Conference 

 

Sponsored by

San Diego Regulatory Affairs Network (SDRAN)

and 

Orange County Regulatory Affairs Discussion Group (OCRA) 

 

Wednesday, November 19, 2014  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 »

October 17th, 2014

NDA Submission Planning & Management from the Medical Writer’s Perspective

The session “NDA Submission Planning & Management from the Medical Writer’s Perspective” will orient the audience to New Drug Application (NDA) structure, the typical challenges faced by the medical writers during the authoring and review process, and strategies for messaging and preparing for internal and agency review.

Saturday, Oct 25, 2014 Read the rest of this entry »

June 24th, 2014

BIOTECH PRIMER: CURRENT SCIENCE TRENDS, ISSUES, AND ADVANCES

June 30, 2014. 5:30 to 8:00 p.m. Read the rest of this entry »

May 9th, 2014

SABPA Bio-Pharma Conference 2014

Date:                     June 21, 2014, 8:00am – 4:50pm Read the rest of this entry »

March 10th, 2014

Leading Teams (From the Front or From Within) Part 3 of 3

Wednesday, March 19, 2014

Read the rest of this entry »

November 19th, 2013

MDR Network Meeting

Orange County Regulatory Affairs Discussion Group

Invites You To

MDR Network Meeting

Tuesday, December 3, 2013
4:00 – 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 23rd, 2013

ASQ San Diego Quality Conference

Increase Your Value as a Quality Professional

November 15-16, 2013

10210 Genetic Center Drive, San Diego, CA Read the rest of this entry »

August 30th, 2013

Global Supplier Management

Evening Event

Global Supplier Management:

Share and Learn Best Practices From Industries with a Long-Standing History of Robust Supplier Quality Programs

Orange County Regulatory Affairs Discussion Group
Tuesday, September 17, 2013 Read the rest of this entry »

August 9th, 2013

The Value of Good Science

Special Summer Event A Night at Discovery Science Center

Orange County Regulatory Affairs Discussion Group

Monday, August 19, 2013

 Location:       

Discovery Science Center

Read the rest of this entry »

March 22nd, 2013

The 12th SABPA Education and Career Development Event 

When:  11:30 am to 2:00 pm, Saturday, April 6, 2013

Where: TBD

Registration: https://www.123signup.com/register?id=bcbsk

$10 ($5 student) until April 1st online; $20 onsite ($10 student onsite)

Weblink: http://www.sabpa.org/web/news_details.php?ID=457

 

Summary: Dr. Yuan Xu (VP, Novartis) and Mr. Brian O’Callaghan (CEO, Sangart) will discuss their career paths, views of leadership, and insights on the skills essential for anyone aspiring to achieve career success in the pharmaceuticals/biotech industry.
Speakers:

Yuan Xu, Ph.D.

Dr. Yuan Xu is currently the Vice President and Head of Biotherapeutics Development Unit located at Novartis La Jolla site. She previously served as Global Head and VP of Process Sciences, Production and Quality at Novartis Biologics, and VP and Site Head for Novartis Biologics at Basel Site from 2008 to 2011. Prior to joining Novartis, Dr. Xu held leadership positions, with increasing responsibilities, at several pharmaceutical and biotech companies including Genentech, GlaxoSmithKline, Chiron Corporation, and Amgen. Dr. Xu has worked on many biotherapeutics including various forms of antibodies, recombinant proteins, antibody-drug conjugates, therapeutic vaccines, gene and cell therapies. Dr. Xu has extensive scientific/technical expertise and development/regulatory experience with multiple successful biotech products including Activase, Pulmozyme, Rituxan, Herceptin, TNKase, Xolair, Raptiva, Avastin, Lucentis, Bexxar, Bacaplemin, Proleukin, Epogen, Enbrel, Prolia, Extavia and Ilaris. Dr. Xu did Postdoc training in Molecular Virology and Gene Therapy from University of California at San Diego Medical School. Dr. Xu has a Ph.D. in Protein Biochemistry from the University of Maryland at College Park and a B.S. in Biochemistry and Molecular Biology from Nanjing University in China.

 

Brian O’Callaghan

Mr. Brian O’Callaghan joined Sangart as President and Chief Executive Officer in June 2008. Mr. O’Callaghan brings a breadth of experience to Sangart, having held senior positions with a number of pharmaceutical and biotechnology companies in both Europe and the US. These include senior positions with Pfizer in the UK and Merck Serono in Germany, before becoming President and CEO of BioPartners, a Swiss based biotechnology company. Since relocating to the US, Mr. O’Callaghan has held senior management positions at Novartis, where he served as General Manager of their Transplantation, Immunology and Infectious Disease businesses, as well as at Covance, a clinical research firm, where he served as General Manager of their Cardiac safety and IVRS businesses. Mr. O’Callaghan joins Sangart from NPS Pharmaceuticals, where he served as Chief Commercial Officer. Mr. O’Callaghan brings his extensive general management background in the pharmaceutical, biotechnology and clinical research sectors, as well as his significant international experience, to lead Sangart through regulatory submission and commercial launch of MP4. Last October, Mr. O’Callaghan led a senior executive team to visit 9 Chinese companies in 5 cities to explore potential partnership opportunities.
Schedule:

11:30 am: Registration and Networking

12:00 pm: Light lunch

12:30 pm: Welcome & speaker introductions

12:40 pm: Presentations

1:30 pm: Q&A

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.

March 4th, 2013

Innovations in Biologics Discovery and Development

 

SABPA Science & Technology Forum – Innovations in Biologics Discovery and Development (March 23, 2013)

 

Innovations in Biologics Discovery and Development

 

Date:                March 23, 2013, Saturday, 8:30am to 1:00pm (Breakfast and lunch will be provided)

Location:         Institute of Americas, UCSD, (Direction available at http://www.sabpa.org/web/news_details.php?ID=449)

Registration:   https://www.123signup.com/register?id=bmgsg

$20 for online registration, $10 for students and  post-docs. $40 for on-site registration, Online registration ends March 20, 2012

 

For the past two decades, biologics have revolutionized the treatment of diseases such as rheumatoid arthritis, psoriasis, Crohn’s disease, diabetes, multiple sclerosis, and are widely used in treating a variety of cancers. Biologics is a rapidly developing field of therapeutics and there is a trend for pharmaceutical and biotech industries to drift toward biologics development due to the promise of biologic drugs.

 

At the SABPA Science & Technology Forum XI, we bring together leaders in academia and the pharma/biotech industry to discuss current trends in biologics discovery and development, as well as challenges in the field. The presentations will address new technologies in discovering novel biologic therapeutics including the use of unnatural amino acids, somatic hypermutation and directed molecular evolution as well as developing biologics delivery platforms. The meeting will cover therapeutic antibodies, proteins, peptides, vaccines and therapeutic areas from cancers, autoimmune to cardiovascular diseases.

Event Program

 

8:00-8:30 Registration & Breakfast
8:30-8:35 Opening Remarks
8:35-8:40 Chairperson of session 1
8:40-9:15 Peter Schultz, Ph.D.

Professor of Chemistry, Scripps Research Institute; and Director of California Institute for Biomedical Research

Title:A Chemist’s Foray into Translational Medicine.

9:15-9:45 Thomas F Bumol, Ph.D.

Vice President of Biotechnology and Autoimmunity, Lilly Research Laboratories, Lilly Biotechnology Center-San Diego

Title: Biotechnology as a Sustainable Source of Pharmaceutical Innovation: the Lilly Biotechnology Strategy.

9:45-10:15 David King, Ph.D.

Chief Scientific Officer, AnaptysBio Inc

Title: Generating Improved Antibody Therapeutics through Somatic Hypermutation in vitro

10:15-10:40 Refreshment Break, Exhibit & Networking
10:40-10:45 Chairperson of session 2
10:45-11:15 Jeremy Barton, M.D.

Vice President, Biotherapeutics Development, Pfizer

Title: Antibody Drug Conjugates: Blockbusters of the Next Decade?

11:15-11:45 Henry Ji, Ph.D.

Chief Executive Officer and President, Sorrento Therapeutics

Title: The G-MAB®Library Technology-Discovery and Development of New Human Therapeutic Antibodies

11:45-12:45 Panel Discussion: Biologics Development

Moderator:                                       

Steve Prestrelski, Ph.D., M.B.A.

Chief Scientific Officer, Xeris Pharmaceuticals, Inc.

Panelist:

1. Bhawanjit Brar, Ph.D., Senior Director, Zensun USA

2. Jean I Liu, M.S., J.D., Vice President, General Counsel and Secretary, Halozyme Therapeutics, Inc.

3. Brenden S. Gingrich, Ph.D., J.D., Partner, Knobbe Martens

4. Tim Tian, Ph.D., Senior Scientist, Laureate BioPharma

5. Olivier Laurent, Ph.D., Director, Protein Science, CovX

12:45-12:50 Closing Remarks
12:50-14:30 Lunch
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 »

September 17th, 2012

FDA, Regulatory and Compliance Update: 2012

 

Wednesday, October 10, 2012

7:30 am – 4:00 pm

Hologic Gen-Probe, Inc.
10210 Genetic Center Drive
San Diego, CA 92121

Register Online

This event is brought to you by the Orange County Regulatory Affairs Discussion Group (OCRA) and San Diego Regulatory Affairs Network (SDRAN).

September 7th, 2012

WBENC West Conference 2012

Rosemarie Christopher at the WBENC conference

Rosemarie Christopher, President of MEIRxRS and Pamela Eason, President of WBENC

Rosemarie Christopher attended the Women Business Enterprise National Council (WBENC) West Conference on September 5-7, 2012 at the Paradise Point Resort in San Diego. MEIRxRS’ family of companies (Med Exec International, Rx Research Staffing and Rx Research Services CRO) are all WBENC certified, the most widely recognized and respected certification in Read the rest of this entry »

August 31st, 2012

Adding Value to Your Product – Building a Market Access Plan

 

Tuesday, September 11, 2012

7:30am-9:30am

BIOCOM Boardroom
4510 Executive Drive, Plaza 7
San Diego, California 92121

Speakers:

Tony Grover, Director of Marketing and Reimbursement, PhotoThera, Inc.

Michael Pollock, Reynolds Pollock & Associate

Achieving optimal reimbursement and market access is a critical success factor for any new health technology in today’s cost-constrained marketplace. While gaining reimbursement is viewed by some organizations as simply a barrier to success that needs to be overcome, many companies are seeking to use their market access capability as a means of positively differentiating the company and their products from the competition.

Even for companies who have no plans to commercialize their new technology themselves, having a well thought out and achievable market access strategy that complements the clinical development strategy, can add significantly to the value of their assets.

Beginning with a thorough understanding global payer needs and evidence requirements, through identifying points of economic leverage, building a compelling value story and generating a robust foundation of evidence, this session will take the participant through a step by step review of the key components of a strategic market access plan.

In addition, the session will identify key challenges to implementation of the strategy by providing a solid understanding of current coding, coverage and payment, and reviewing how best to create and communicate compelling value messages for the key stakeholder audiences.

As usual, there will be ample time for a Q&A session and opportunity to network with your industry colleagues.

Register now!

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 

August 15th, 2012

Build Your Personal Brand

Date: Wednesday, September 12, 2012

Time: 5:30 pm – 8:30 pm

Location: 12400 High Bluff Drive, San Diego, CA 92130

Registration: http://pgc200.org/events/62

Build Your Personal Brand and Network using LinkedIn

A presentation by Ron Nash Founder, Dream Job University Ron Nash is author of the first comprehensive online LinkedIn training, Leveraging LinkedIn. His latest book, “Leveraging LinkedIn: The Essential Guide To Your Career Network” was published in July of 2012. Ron has helped the Fortune 500 companies Microsoft, T‐Mobile, The Anthony Robbins Companies, Samsung, Cardinal Health, Biogen‐Idec, and others leverage social media as a business and career development tool. Ron has presented his concepts to audiences nationwide at UCLA, UCSD, AACS, CEA, and ITT Technical Institute. Through working with individuals tp achieve business and life success, he has collaborated with Cesar Millan, “The Dog Whisperer”, Deepak Chopra, Eckhart Tolle, and numerous others. Ron lives in San Diego California with his wife, two children, two cats (Yin & Yang) and their beloved dog, Buddha.

Two books will be raffled to participants at the presentation. Come with your most pressing LinkedIn questions for Ron.

Register at http://pgc200.org/events/62

Registration online: $15 (until September 11), $10 student/in transition Onsite $20, $15 student/in transition

February 24th, 2012

SABPA Education and Career Development

Come by and visit our exhibit booth at SABPA’s 8th Annual Education and Career Development Event on Saturday, February 25th from 11:30am to 2:00pm at Institute of the Americas UCSD, La Jolla, CA 92037. Register now!

Program:

11:30 am – Registration & Networking

12:00 pm – Light lunch

12:30 pm – Welcome: David Jiang, Ph.D., MBA, Managing Director, BIOCOM China Consulting

12:35 pm – Speaker Introductions:

Jinghong Li, M.D., Co-Chair, Education and Career Development Committee, SABPA

Jingfeng Huang, Ph.D., Co-Chair, Education and Career Development Committee, SABPA

12:40 pm – Bhasker V. Shetty, Ph.D., Vice President, Pfizer Worldwide R&D and Site Director of Pfizer La Jolla Laboratories

1:05 pm – Magda Marquet, Ph.D., Co-Chair & Founder, Althea Technologies

1:30 pm – Q&A

1:55 pm – Wrap-up & SABPA Upcoming Events: Peter Zhu, President, SABPA San Diego

Logos of our membershipsmore Logos of our memberships