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Analytical Methods Validation for FDA Compliance

 
  December 05, 2016  
     
 
CfPA-The Center for Professional Advancement, Burlingame, CA
October 23-25, 2017


Who Should Attend?
This course is intended for individuals who have the responsibility for establishing the integrity of analytical methods for active pharmaceutical ingredients (APIs) or finished pharmaceutical dosage forms. This course will benefit individuals in:

  • R&D 
  • Quality Control
  • Quality Assurance 
  • Technical Operations

Regulatory affairs personnel responsible for the review of such data will also benefit from this course.

RAPS - Regulatory Affairs Professional Society 
This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's recertification of their Regulatory Affairs Certification (RAC) upon full completion.

Course Description
One of the most critical factors in developing and marketing pharmaceutical drug substances and drug products today is ensuring that the analytical methods used for analysis can generate valid data upon which business and regulatory decisions can be made. FDA, ICH and USP have each recognized the importance of this to the drug development process and have separately expanded method validation requirements in recent years. However, with only limited guidance, industry has been left to interpret how to adequately comply with the regulations. 

Whether involved in method development, method validation, method verification or method transfer, this course will provide a broad understanding and “hands-on” knowledge of the method validation process and the difficulties encountered in validating methods to comply with today’s upgraded FDA CDER requirements. Lectures will include not only theoretical basis and practical applications, but actual validation examples of HPLC, GC, UV/Vis, AA and titration methods for small organic molecules. Some of the more common mathematical and statistical treatments of validation data will also be discussed. Because of the tremendous effort that can be expended in conducting validation studies, efficiency of experimental design and documentation will be stressed throughout the discussions.

Although the general principles in this course may be applied to methods for testing biological molecules and medical devices, the focus of this course is on the validation of methods for the analysis of small molecules and not the unique analytical procedures often used for testing products of a biological nature.
 
 
Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
Course Director
J. Mark Green, Ph.D.; Pharmaceutical CMC Consultant

Dr. J. Mark Green is a Pharmaceutical CMC Consultant, providing expertise and practical guidance in CMC development from pre-IND phase through commercialization.

Dr. Green was previously Director of Pharmacy and Analytical Development with Lautheus Medical Imaging, where he was responsible for the development, validation, and transfer of analytical methods for drug substances and drug products. Additionally, he was responsible for stability testing, analytical support of safety assessment studies, and the preparation of CMC sections of regulatory submissions.

Dr. Green has over 26 years of experience in drug development, and previously worked for Bristol-Myers Squibb, DuPont Merck and DuPont. He has published and lectured on analytical method validation, and on applications of HPLC, TLC, and Chiral Chromatography. Dr. Green received his PhD in Analytical Chemistry from the University of Illinois.

 

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Course Director
David E. Wiggins; Sr. Associate Director of Analytical Development, Bayer Consumer Care

David E. Wiggins is Sr. Associate Director of Analytical Development for Bayer Consumer Care with responsibility for pre-market stability, analytical method validation and method transfer. 

Prior to joining Bayer, Mr. Wiggins worked for Schering-Plough and Merck with responsibility for Method Optimization, Method Validation, Method Transfer and Stability (both pre- and post-market). These responsibilities have additionally included involvement with multiple NDA submissions and FDA general and PAI inspections. 

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.
 
Deadline for Abstracts: N/A
 
Registration: Please click here for registration information.
E-mail: Jmorbit@cfpa.com
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