Our next USP Western Compendial Discussion Group (WCDG) - AOAC Southern California Section (SCS) Joint Two-Day Conference will be held at Chapman University School of Pharmacy, ATRIUM Room, located at 9401 Jeronimo Rd., Irvine CA, on Wednesday, June 26, and on Thursday, June 27, 2019.  


​Please find the conference agenda below. We look forward to seeing you in our 2019 SpringConference.

Parking, Breakfast and Lunch Included!​






AOAC SCS Conference in Partnership with United States Pharmacopeia (USP)

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Agenda

 USP WCDG & AOAC SCS Joint Two-Day Regulatory & Compliance Conference,

Chapman University, School of Pharmacy,
Harry and Diane Rinker Health Science Campus,
9401 Jeronimo Rd., Irvine, CA 92618, ATRIUM ROOM,
Critical Regulatory and Compliance Issues with the US FDA in the 21st Century



DAY 1 - Wednesday, June 26, 2019


7:15 A.M.       Registration & Continental Breakfast

8:15 A.M.       Welcome Remarks by

                        Sumit Sen, Ph.D., US FDA/ORA/ORS, Pacific Southwest Laboratory, Irvine, CA,

                        President, AOAC SCS & USP WCDG, & Master of Ceremony


                        Roberto Shimahara, Director-Strategic Customer Development, and

                        Matthew Vankoski, Senior Strategic Customer Development Manager,
                        United States Pharmacopeia, Rockville, MD


                        Ronald Jordan, Ph.D. Dean, Chapman University School of Pharmacy, Irvine, CA

8:45 A.M.       
KEYNOTE SPEAKER: Xiaohui (Jeff) Jiang, Ph.D.
                        US FDA/CDER/OGD/ORS/DTP, Silver Spring, MD
                       
TOPIC: Challenges and Opportunities for Innovation in Complex Generic Drug Product Development

9:35 A.M.       Danita Broyles, Senior Customer Engagement Manager
                        United States Pharmacopeia, Rockville, MD
                       
TOPIC: Deficiencies in Raw Materials ID Testing


10:25 A.M.     Refreshment Break                       

11:10 A.M.     Mitchell Herbal, Ph.D.
                        Technical Director, BioScreen Testing, Torrance, CA
                       
TOPIC: Preservatives – Analysis and Review of Current Trends in Pharmaceutical and Personal Care Products

12:00 P.M.     Lunch Break and Networking


01:00 P.M.     Isabelle Vu Trieu

                        Waters Corporation, Milford, MA
                        
TOPIC: Method Life Cycle Management


1:50 P.M.       Sponsor Presentations


2:30 P.M.       Panel Discussion Session

4:30 P.M.       Adjourn



DAY 2 - Thursday, June 27, 2019


7:30 A.M.        Registration & Continental Breakfast

8:30 A.M.       
KEYNOTE SPEAKER: Bhagwant Rege, Ph.D.
                         US FDA/CDER/OPQ/OLDP/DMRP, Silver Spring, MD
                       
 TOPIC: Complex Generic Drug Device Combination Products: Quality Expectations


9:20 A.M       
 Maura Kibbey, Ph.D., Senior Scientific Fellow, Education & Training, Global Biologics

                         United States Pharmacopeia, Rockville, MD
                         
TOPIC: USP Standards for Characterization of Recombinant and Synthetic Peptides


10:10 A.M      Refreshment Break

11:10 A.M.     Timothy Moseley, Ph.D.
                        Chief Scientific Officer, Direct Biologics, Carlsbad, CA
                       
TOPIC: Biologics and Regenerative Medicine     


12:00 P.M.      Lunch Break and Networking


1:00 P.M.        Christopher Mark Sasso, Imaging and Raman Business Development

                         Agilent Technologies, Santa Clara, CA

                         TOPIC: Advances in Chemical Imaging - Bringing clarity and speed to chemical imaging

1:50 P.M.        Sponsor Presentations

2:30 P.M.        Panel Discussion Session

4:30 P.M.        Adjourn

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Or


Southern California Section