Who Should Attend

Because of its comprehensive content, this course will be valuable to personnel in stability, research and development, regulatory affairs, manufacturing, quality assurance, and the quality control laboratory, who are involved in conducting, supervising, or managing stability testing.  This includes those whose job responsibilities require an in-depth knowledge of the FDA regulations and ICH guidelines as applied to establishing stability programs and conducting stability testing.




Learning Objectives

Providing a step-by-step foundation for determining product shelf life through stability testing, this comprehensive training course outlines the issues and guidelines surrounding FDA and ICH regulatory requirements.  Specifically, this course will focus on establishing a successful stability program through in-depth discussions on writing and revising stability protocols, stability sample management, stability indicating assays, out of specification results, and deviations. Sample 483s are reviewed to better understand typical deficiencies and how to avoid them.

Practical techniques are reviewed to improve the integrity of the stability data and ensure that test results comply with FDA and ICH requirements. By the end of the two-day course, attendees will gain the skill set to interpret regulatory guidelines, design compliant stability program, and effectively prepare for an FDA inspection in their stability testing laboratory and sample storage facility.

Course Description

This continually updated course covers current FDA regulatory requirements and ICH guidelines as applied to designing stability programs from the early stages of product development all the way to approval.  Among the topics to be discussed will be: identifying FDA’s regulations and ICH guidelines for stability testing, writing study protocols and SOPs, designing and validating stability indicating analytical test methods, establishing Successful Stability Data Management Systems, conducting and documenting OOS results and deviations, and preparing for an FDA inspection of stability program.

“The course was taught very well.  Being new to the industry, I found it extremely useful.  The course director is very engaging in his presentation and has my brain thinking about a lot of non-statistical issues (statistics is my specialty).  Thank you very much!”
Eileen D., Quality Engineer, Amgen

“Very informative course and the instructor was very interesting.  He made a real effort to move through the information quickly, yet answered each and every question.”
Barbra D., QC Stability Supervisor

“Excellent course for someone new to the field.  Instructor was very knowledgeable and presents well.” 
Chris M., Quality Assurance Associate, First Horizon Pharmaceuticals

“Very informative!” 
Kathy F., Stability Tech, Teva Pharmaceuticals

“A lot of information covered but managed well by instructor.  Excellent course.” 
Tom H., Product Development Leader, Multisorb Technologies, Inc.

“The course was very good.  Notes provided are great and useful for future reference.  I will definitely stay in contact for additional information.”
Jennifer S., QE Analyst, Sanofi Pasteur

"The Center's small classes and this knowledgeable instructor with real-life experience made this course worthwhile.  The instructor was very well prepared to answer all questions that were asked."
Chemist, Aventis

“What a wonderful experience and opportunity to learn for a relative newcomer to the industry and stability!  The pace of the course was fantastic and I really enjoyed the discussion on bracketing and matrixing!”
Michael G., Assistant Scientist, Pfizer

“Very informative.”
Johanna P., Stability Analytical Chemist, Accra Pac

"Course was very helpful as an overview of stability issues."
Aniello P., Stability Manager, GSK

"The information presented in this course was very informative.  The class was able to do group projects which was a significant aid in the understanding of course material.  I am very impressed with the binder of handouts that was provided with the course and I'm sure that I will use it in the future."
Sarah D., Research Associate, Isis Pharmaceuticals

"Excellent course for regulatory affairs personnel.  The course content was very comprehensive and provided material that will be of great use to me and my colleagues."
Alex P., Forest Research Institute