Stability Programs for Product Shelf Life – From Development to Approval™

This comprehensive course will be valuable to personnel evaluating stability of new chemical entities (NCEs) and new molecular entities (NMEs). Additionally, this course will be of great benefit to those in research and development, manufacturing, quality assurance, the quality control laboratory and regulatory affairs who are involved in conducting, supervising, or managing stability testing.  This includes those whose job responsibilities require an in-depth knowledge of the FDA guidelines and ICH regulations as applied to establishing stability programs and conducting stability testing.

Providing a step-by-step foundation for establishing 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 (OOS) results, and deviations.

Practical techniques are reviewed to improve the integrity and predictability of 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 necessary to interpret regulatory guidelines, design compliant stability programs, and effectively prepare submission-ready documents for  FDA inspections of their stability testing laboratories and sample storage facilities. Sample 483s are reviewed to better understand typical deficiencies and how to avoid them.

This continually updated course covers current FDA regulatory requirements and ICH guidelines for designing stability programs from the early stages of product development all the way to approval.  Among the topics to be discussed will be:

• FDA’s guidelines and ICH regulations 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 investigations and deviations
• Preparation for inspection of stability programs as part of the approval process by regulatory agencies

Additionally, case studies will be covered for small molecule NCEs, large molecule NMEs, polymer therapeutics and photodynamic chemotherapy.

“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