| Dear Esteemed Invitees, |
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| 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, June 27th, and on Thursday, June 28th, 2018. |
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We are extremely excited that we will have several knowledgeable speakers from the US FDA, INDUSTRY AND CONSULTING FIRMS at this conference:
Eminent Speakers include: |
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DAY 1 – June 27, 2018
Mahesh Ramanadham, Ph.D.
US FDA, CDER/OPQ/OPF/DIA, Silver Spring, MD
TOPIC: The Integration of Quality Assessments and Inspection
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Aryo Nikopour
Senior Vice President, Scientific & Technical Services,
Nitto Avecia Pharma Services, Irvine, CA
TOPIC: Systematic Approach to Extractables & Leachables: A Review of
Guidance from the Industry
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Timothy Moseley, Ph.D.
Scientific Consultant, Paisley Laboratories, LLC, San Diego, CA
TOPIC: Stem Cell Research and Management of Regulatory Requirements
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DAY 2 – June 28, 2018
Susan Rosencrance, Ph.D.
Director, FDA/OMPT/CDER/OPQ/OLDP, Silver Spring, MD
TOPIC: The Modernization of Quality Assessments for Generic Drugs
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Lokesh Bhattacharyya, Ph.D.,
Chief, US FDA, CBER/OCBQ/DBSQC/LACBRP, Silver Spring, MD
TOPIC: Replacing Analytical Methods for Biologics-Pre-Approval and Post-Approval
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Danita Scott Broyles
Merck Compendial Affairs - Senior Compendial Affairs Specialist, West Point, PA
TOPIC: USP’s General Chapter <661> Plastics Packaging used in Pharma & Medical
Device Industries & its Challenges
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To register or to learn more about this exciting event, visit:
http://www.aoac-scs.org/2018-spring-conf.html
We look forward to seeing you at this conference!
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Thank you.
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Sumit Sen, Ph.D., President AOAC SCS
on behalf of AOAC SCS - USP WCDG Executive Committee Members
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