Course Description

OTC Stability Program for FDA Compliance

March 28-29, 2019
New Brunswick, NJ

Course Offering 190328NJ2650
Course ID 2650

In-Person Course

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
  • QA/QC
  • Technical Operations
  • Contract Laboratories

WATCH THE VIDEO...Meet the Instructor and Learn More About this Course

Course Description
In 2006, FDA withdrew both their approved 1987 Stability Guideline and their draft 1998 Stability Guidance and referred industry to the ICH Stability Guidances. With the ICH guidance documents covering New Chemical Entities (NCEs) and their associated drug products, there was no guidance provided for OTC drugs covered by an ANDA or OTC monograph. In 2014, FDA issued Guidance for Stability testing requirements for all drug products covered by an ANDA, but no guidance has been provided for OTC monograph drug products.

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.

This 2-day intensive course will provide an understanding of how the pre-market stability programs can be successfully managed while minimizing the overall timeline. Lectures will address the seven key GMP aspects of a stability program along with all of the relevant ICH, FDA, WHO and CHPA guidelines that cover drug product stability. Accelerated testing that allows the marketing of a new OTC drug product prior to the generation of long term, real time stability data and confirmation of the stability projections through an appropriate post-market stability program will also be covered.

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
venue
The Heldrich Hotel
10 Livingston Avenue
New Brunswick , NJ 08901 US
Phone: 732-729-4670
Fax: 732-729-4672
Website: The Heldrich Hotel

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.