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

Blake Bevill,

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

Daniel Solis

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?

Jana Hildreth

CEO & Technical Director, Blaze Science Industries LLC, Rolling Hills, CA

9:40 am           Topic: Industry Involvement in USP Monograph Development for Dietary Supplements

Blake Ebersole

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

Aryo Nikopour
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