Implementing an FDA Compliant Stability Program

At the end of the two-day course attendees will:

• Gain a solid understanding of the regulatory compliance requirements and expectations (FDA, EMA, ICH, WHO) for API and drug product stability programs, for both chemical drugs and biologics
• Have the tools and understanding to develop and implement a regulatory compliant stability program that is clinical phase-appropriate, incorporating Quality Risk Management (QRM)
• Understand the ICH Q8, Q9 and Q10 Quality by Design (QbD) approach applied to the stability program as part of an effective control system
• Be able to appropriately package stability information into Module 2.3 and Module 3 of the Common Technical Document (CTD)
• Learn how to avoid major delays in clinical development or market approval due to an ineffective stability program

Why Product Stability Profiles Are Necessary

• Terminology defined: shelf life specification, expiration date, shelf life, stability-indicating assay, re-test date, in-use period
• Long-term vs. accelerated vs. stress (forced degradation) testing – value and limitations
• Patient safety impact of an ineffective product stability assessment

Regulations and Guidances on Product Stability

• Regulatory stability requirements – FDA and EMA
• ICH Q, FDA, EMA, WHO and pharma industry stability guidances – similarities and differences between chemical drugs and biologics
• Handling out-of-specification (OOS) stability test results

Clinical Phase-Appropriate Stability Programs

• Preliminary stability assessment for early stage clinical development
• Thorough stability programs for late stage clinical development
• Significant differences between API and DP stability studies, and between FDA and EMA stability expectations, during clinical development

Stability Program Prerequisites

• Critical importance of an effective stability sample tracking system
• Appropriate and adequate qualification, maintenance and calibration of stability chambers/storage units
• Selection of relevant stability-indicating test methods – similarities and differences between chemical drugs and biologics

Effective Design of a Formal Stability Protocol

• Role of Quality by Design (QbD) in the formal stability program
• Key stability study parameters – batch selection, storage conditions, testing frequency, stress conditions, in-use period
• Bracketing and matrixing study design

Statistical Approaches to Setting Shelf Life

• Understanding of basic statistics - mandatory
• Regression line and Arrhenius plot extrapolations
• Defining what is a ‘significant change’

Preparing CTD Regulatory Submissions on Product Stability

• Stability data presented in Module 2.3 Quality Overall Summary, and Module 3 Quality of the CTD – minimum data requirements and formatting
• Post-approval stability protocols and stability commitments
• ‘Stability budget’ and product distribution stability study reporting

Managing Regulatory Authority Stability Interactions/Inspections

• Inspector interest in product stability studies – what they want to see and why
• Regulatory report card on pharmaceutical stability programs – case examples in Warning Letters and cGMP certification withdrawals
• Ultimate regulatory authority concern – stability data fabrication

Please Note: This course primarily covers pharma products. Medical Devices are not addressed in this training program.

"The course binder we received will be a great tool in the future and it was useful while the course was happening for note taking."

Alex K., Stability Coordinator, Particle Sciences

"It was the most relevant and thorough course for my work."

Mitchell G., R.A. Quality Control, AGTC

"In comparison to courses I've taken with other providers this was an excellent presentation with examples and discussion."

Rita P., PhD, Associate Director for Product Stability, Celularity

"This course was very informative and contained great real world scenarios/examples relating to stability topics."

Efren B., Senior Scientist, Analytical Development, Celgene

"The background material was very helpful and provided a good foundation to the applications of shelf-life assignments."

David M., Director Quality and Analytical Technology, Ironwood Pharmaceuticals

"The course director did an excellent job putting things straight. This was the most comprehensive course I ever attended. I am grateful and I will take advantage of the information I received."

Thomas B., QC Manager, Neovii Biotech

"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

"The course was taught very well. Being new to the industry, I found it extremely useful. The course director is very engaging in the 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. There was a real effort to move through the information quickly, yet answered each and every question."

Barbara 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

"Course was very helpful as an overview of stability issues.;

Aniello P., Stability Manager, Glaxo (GSK)

"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