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HUM-MOLGEN
-> Events
-> Courses and Workshops |
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April 20, 2015 |
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CfPA-The Center for Professional Advancement, New Brunswick, NJ
October 19-20, 2015
Who Should Attend?
This course is intended for individuals who have the responsibility for establishing the stability of Over-the-Counter (OTC) drug products. This course will benefit individuals in:
• R&D
• Quality Control
• Quality Assurance
• Technical Operations
• Contract Laboratories Course Description
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Organized by:
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CfPA-The Center for Professional Advancement |
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Invited Speakers:
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| David E. Wiggins; Director, Analytical/Stability R&D, Merck Consumer Care |
David E. Wiggins is Director of Analytical/Stability R&D for Merck Consumer Care (formerly Schering-Plough Consumer Health Care). Since joining the company in 1982, Mr. Wiggins has worked in both Quality Control and Research and Development with responsibility for Method Optimization, Method Validation, Method Transfer and Stability (both pre- and post-market). These responsibilities have additionally included involvement with every NDA submission and every FDA inspection of the division since 1991.
Mr. Wiggins has over 30 years experience in the pharmaceutical industry in both a QC and an R&D setting. During this time, he has been instrumental in establishing and updating stability and method validation policy to be consistent with the changing regulatory requirements. Mr. Wiggins has frequently lectured on stability and analytical method validation in the US, Puerto Rico, and throughout Europe. He has been active in submitting comments and validated stability-indicating analytical methods to the U.S. Pharmacopeia and has been an invited speaker to FDA, university, and industry conferences.
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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sberg@cfpa.com
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As a result, strictly following the ICH stability guidance for NCEs is unwarranted and ignores this significant database of information that is typically available for OTC drug products. For OTC drug products covered by an OTC monograph or an ANDA, there is frequently years of proven experience with the drug substance as well as the drug product. It is this body of data that can often be used to justify a pre-market stability program that represents a subset of the full ICH NCE stability requirements.
Whether involved with OTC drug products covered by an NDA, ANDA, or OTC monograph, this course will provide an understanding of how the pre-market stability programs can be successfully managed while minimizing the overall timeline, a key factor to the timely launch of new products. Lectures will address the six key GMP aspects of a stability program along with all of the relevant ICH, FDA, WHO and CHPA guidelines that cover drug product stability. An important aspect to be covered is the successful use of accelerated testing that allows the marketing of a new OTC drug product prior to the generation of long term, real time stability data. Confirmation of the stability projections through an appropriate post-market stability program will also be covered. Participants will also be able to get answers to their questions about the stability of OTC drug products.