Critical Regulatory and FDA Compliance Issues
Critical Regulatory and Compliance Issues with the US FDA in the 21st Century
Spring AOAC SCS – USP WCDG Joint Conference – “Critical Regulatory and Compliance Issues with the US FDA in the 21st Century”
When: 7:00 am to 4:00 pm, Thursday, March 7 & Friday, March 8, 2013
Where: US FDA facility located at 19701 Fairchild, Irvine, CA 92612.
Conference Organizer: AOAC Southern California Section (SCS) – USP Western Compendial Discussion Group (WCDG)
Conference Summary: This conference will be focused on Dietary Supplements and on Method Development & Validation.
Registration: please visit the AOAC SCS Website: http://www.aoac-scs.org/2013_Spring_Conference.html. As a benefit, SABPA members (need to mention that you are a SABPA member when registering) can register to this 2-day conference with the same registration fee as AOAC SCS members without paying the AOAC SCS membership fee.
DAY 1 – Thursday, March 7, 2013
7:00 A.M. Registration
8:30 A.M. Welcome Remarks by
Alonza Cruse, Director,
Los Angeles District Office, US FDA, Irvine, CA
William Martin, Ph.D.,
Laboratory Director, PRL-SW, US FDA, Irvine, CA
Yan-Bo Yang, Ph.D.,
President, Biopharmadev, Inc., Corona, CA, & President, AOAC SCS
Sumit Sen, Ph.D., US FDA, PRL-SW, Irvine, CA,
President, USP WCDG,
& Meeting Host
9:00 A.M. Topic: LOS-DO Compliance Actions against Dietary Supplement Firms
Compliance Director, LOS-DO, US FDA, Irvine, CA
9:50 A.M. Topic: Update on NIH’s Activities in the area of Dietary Supplements
Joseph M. Betz, Ph.D.
Director, Analytical Methods and Reference Materials Program, Office of Dietary Supplements, National Institutes of Health, Bethesda, MD
10:40 A.M Refreshment Break
11:00 A.M. Topic: Dietary Supplements Current Adulteration Issues to Consider while
Setting Product Specifications
Mark Roman, Ph.D.
President, Tampa Bay Analytical Research, Inc., Clearwater, FL
11:50 A.M. Topic: Challenges regarding Reference Standards in Dietary Supplements
Mitzi Rettinger, Vice-President, Sales & Marketing, Cerilliant Corporation, Round Rock, TX
12:40 P.M. Sponsor Presentations
1:00 P.M. Lunch Break
2:00 P.M. Panel Discussion Session
4:00 P.M. Adjourn
DAY 2 – Friday, March 8, 2013
7:00 A.M. Registration
8:00 A.M. Topic: Import Compliance Related Issues related to Dietary Supplements
Director, Import Operations Branch, LOS-DO, US FDA, San Pedro, CA
8:50 A.M. Counterfeit C of A’s: From Raw Material to Finished Product-What to Look For?
CEO & Technical Director, Blaze Science Industries LLC, Rolling Hills, CA
9:40 am Topic: Industry Involvement in USP Monograph Development for Dietary Supplements
Technical Director, Verdure Sciences, Noblesville, IN
10:30 A.M. Refreshment Break
10:50 A.M. Topic: USP Update/Activities on Dietary Supplements
Nandakumara (Nandu) Sarma, R.Ph., Ph.D.
Director, Dietary Supplements, USP, Rockville, MD
11:40 A.M. Phase Appropriate Method Development and Validation
Vice-President, Scientific and Technical Services, Irvine Pharmaceutical Services, Irvine, CA
12:30 P.M. Method Validation and Verification in Dietary Supplements
Lorraine Shelton, ASQ CQA
HSEQ Officer, Exova Health Sciences, Santa Fe Springs, CA
1:20 P.M. Sponsor Presentations
1:45 P.M. Lunch Break
3:00 P.M. Panel Discussion Session
4:30 P.M. Adjourn