Course Description

Analytical Methods Validation for FDA Compliance

March 23-25, 2020
Edison, NJ

Course Offering 200323NJ1887
Course ID 1887

In-Person Course

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 as well as regulatory authorities who are responsible for the review of such data will also benefit from this course.

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.

“ “Excellent! Very informative and contained most recent FDA changes. Even though both instructors agree on the topic, they have two very different approaches. I would recommend this course, as a CRO company our clients rely on us to know the regulations and processes.”
B.M., Senior Scientist/Team Leader, Eurofins

Course Director
J. Mark Green, Ph.D., Analytical Chemistry Consultant

Dr. J. Mark Green is an Analytical Chemistry Consultant, providing expertise and practical guidance in analytical 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 30 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, Analytical/Stability Consultant

David E. Wiggins is an Analytical/Stability Consultant within the pharmaceutical industry with a focus on pre-market stability, analytical method validation and method transfer.

Mr. Wiggins was previously Sr. Associate Director of Analytical Development for Bayer Consumer Care. 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, ANDA submissions and FDA general and PAI inspections.

Mr. Wiggins has over 35 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.

Venue Information
ExitCertified (MicroTek partner facility)
Raritan Plaza III
105 Fieldcrest Avenue, Suite 405
Edison , New Jersey 08837
Phone: 800-207-9620 (for directions and parking info only)

PLEASE NOTE: Participants must make their own reservations; the cost of hotel accommodation is not included in the course fee. Final hotel information will be emailed to you in your confirmation package approximately 3 weeks prior to the course start date.

Directions: Visit the Hotel Venue topic on our FAQ page.