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, December 4, and on Thursday, December 5, 2019.  


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

Parking, Breakfast and Lunch Included!​






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

​​

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, December 4, 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: Vilayat A. Sayeed, Ph.D., Director, Division of IR Products 1
                        US FDA/CDER/OPQ/OLDP, Silver Spring, MD
                       
TOPIC: : An Update on CDER’s KASA Initiative

9:35 A.M.       Desmond Hunt, Ph.D., Principal Scientific Liaison, United States Pharmacopeia
                        Rockville, MD
                       
TOPIC: Controlling Particulate Matter in Injectable Drug Products


10:25 A.M.     Refreshment Break                       

11:10 A.M.     Mark Wiggins, Owner & Compendial Consultant (Retired Director, Compendial Affairs, Merck, West Point, PA)
                        Global Pharmacopoeia Solutions LLC, Dresher, PA
                       
TOPIC: Challenges in Pharmacopoeia Compliance

12:00 P.M.     Lunch Break and Networking


01:00 P.M.    Kamaljit Kaur, Ph.D., Associate Professor of Medicinal Chemistry & Associate Editor, Scientific Reports NPG

                        Chapman University-School of Pharmacy, Irvine, CA
                        
TOPIC: Breast Cancer Detection and Treatment with Engineered Peptides


1:50 P.M.       Sponsor Presentations


2:30 P.M.       Panel Discussion Session

4:30 P.M.       Adjourn



DAY 2 - Thursday, December 5, 2019


7:30 A.M.        Registration & Continental Breakfast

8:30 A.M.       
KEYNOTE SPEAKER: Derek Smith, Ph.D., Branch Chief

                         US FDA/CDER/OPQ/OPF, Silver Spring, MD                         
                       
 TOPIC: CDER’s KASA Initiative: Manufacturing and Inspection Assessment Perspectives


9:20 A.M       
 Matthew Vankoski, Senior Strategic Customer Development Manager

                         United States Pharmacopeia, San Diego, CA
                         
TOPIC: USP’s Latest Status on Monograph Modernization


10:10 A.M      Refreshment Break

11:10 A.M.     Kwasi Antwi, Ph.D., Field Application Scientist, Biopharma Applications
                        Thermo Fisher Scientific, San Francisco, CA
                       
TOPIC: HR Multi-Attribute Method for Critical Quality Attribute Monitoring and New Peak Detection


12:00 P.M.      Lunch Break and Networking


1:00 P.M.        Ashok Bhagat, M.S., Associate Director, Laboratory Technical Services

                         Par Pharmaceuticals, Irvine CA

                         TOPIC: Analytical Method Life Cycle – Industry Perspective

1:50 P.M.        Sponsor Presentations

2:30 P.M.        Panel Discussion Session

4:30 P.M.        Adjourn

​​

Or


Southern California Section