|
 |
|
|
|
| AOAC SCS Conference in “Grand Partnership” with United States Pharmacopeia, "Critical Regulatory and Compliance Issues with the US FDA in the 21st Century" - REGISTERTODAY! |
|
|
|
| Conference Topics: Current Critical Issues on Pharmaceuticals, Biopharmaceuticals & Medical Devices...Emphasis on Impurities and Excipients |
|
|
| |
| Dear Esteemed Invitees, |
| |
| We are elated to announce that the next AOAC Southern California Section (SCS) - USP Western Compendial Discussion Group (WCDG) Joint Two-Day Conference will be held at Chapman University School of Pharmacy, located at 9401 Jeronimo Rd., Conference Room 181, Irvine CA, on Wednesday, December 12th, and on Thursday, December 13th, 2018. Parking, Breakfast and Lunch will be included. |
| |
We are extremely excited that we will have several knowledgeable speakers from the US FDA, US Pharmacopeia (USP), INDUSTRY AND CONSULTING FIRMS at this conference:
Eminent Speakers include: |
|
| DAY 1 – December 12, 2018 |
| |
Bing Cai, Ph.D.
US FDA/CDER/OPQ/OLDP/DBLP, Silver Spring, MD
TOPIC: Pharmaceutical Lifecycle Management: What’s New in the ANDA
Impurities Assessment Under GDUFA II? |
| |
Catherine Sheehan, PhD.
Senior Director, Excipients
TOPIC: USP Strategies for Excipients Standards Setting: Why Excipients are so Important |
| |
Dilip Choudhury, Ph.D.
Pharmaceutical Consultant, Cary, NC & Former VP, Analytical Sciences and
Microbiology, Allergan, Irvine, CA
TOPIC: Ensuring Quality of Pharmaceuticals Throughout Their Life Cycle - Control of Impurities |
| |
| Kim Huynh Ba |
| |
Executive Director, PHARMALYTIK, Greater Philadelphia Area, PA
TOPIC: Monitoring Organic Impurities in the Stability Program |
|
| DAY 2 – December 13, 2018 |
| |
Gurpreet Gill-Sangha, Ph.D.
US FDA/CDER/OMPT/OPQ/OLDP/DPMAI/PMBII, Silver Spring, MD
TOPIC: Overview of Drug Product Quality from the FDA Perspective |
| |
Antonio Hernandez-Cardoso, Ph.D.,
Senior Scientific Liaison, United States Pharmacopeia, Rockville, MD
TOPIC: Modernization of Organic Impurities Testing in USP Monographs
Ghazal Alipour, Ph.D. |
| |
Field Application Engineer, TA Instruments, Long Beach, CA
TOPIC: An Introduction to DSC, TGA, DMA and Rheology for Characterizing Materials in the Medical Device Industry |
| |
Mark Alsandro, Ph.D.
Director, Analytical Development and Control, Orexigen Therapeutics, La Jolla, CA
TOPIC: Enhancing Pharmaceutical Quality through Predictive Stability
Approaches including the Effect of Impurities |
| |
| To register or to learn more about this exciting event, visit:
|
|
| http://www.aoac-scs.org/2018-december-conf.html |
|
| We look forward to seeing you at this conference! |
| |
| Thank you. |
| |
Sumit Sen, Ph.D., President AOAC SCS
on behalf of AOAC SCS - USP WCDG Executive Committee Members |
| |
|
|
|