Stability Program for Pharmaceuticals and Biologics

Why Should You Attend:

This interactive webinar will begin with an overview of ICH requirements for stability programs and address current FDA requirements for stability studies during Phase I, Phase II, Phase III clinical studies including shipping studies and in-use studies. The requirements for post approval stability studies will also be discussed. It will discuss how to choose the right methods and specifications to include in a stability study during the different development phases.

The second half of the webinar will address the practical aspects of how to set up, conduct and complete a stability study. Common pit falls and lessons learned from recent warning letters related to deficiencies in stability programs will also be discussed to understand current trends in the industry and regulatory enforcement.

This webinar is designed to be part of the Annual GMP training required for all Pharmaceutical industry laboratory personnel.

Areas Covered in the Webinar:

• Overview of ICH and WHO requirements for stability programs
• What are the FDA requirements for stability studies during Phase I, Phase II, Phase III clinical studies
• What are the required post approval stability studies
• How to set up, conduct and complete a stability study
• How to choose the right stability study analytical methods and specifications
• What are the common pit falls and lessons learned from warning letters

Who Will Benefit:

• QC laboratory staff
• QC supervisors and management
• QA management
• Regulatory affairs personnel
• R&D lab personnel
• R&D lab supervisors

Nanda Subbarao
Senior Consultant, Biologics Consulting Group

Dr. Subbarao, holds a Ph.D. in Bio-organic Chemistry. She is currently a Senior Consultant with the Biologics Consulting Group specializing in Analytical, Stability, CMC and GLP/GMP Quality Systems. Her hands-on industrial experience covers stability and laboratory cGMP systems for both biologics and conventional drugs. As a consultant she has assisted pharma and biotech organizations in evaluation of analytical methods and method validation for a wide range of products ranging from conventional drugs to well characterized proteins and vaccines, from pre-clinical phase to commercial phases. She has been involved several times over her career in projects to setup or upgrade cGMP/GLP complaint Quality Systems for laboratory and stability programs for products during development and in commercial phase. She serves on the AAPS Stability Focus Group Steering Committee.

Topic Background:

The Stability Program is a key component of product development. The time scale for a stability studies is relatively long, ranging from 2-3 years and is very often on the critical path of the product development project. When errors are found in the study design, there may be need to repeat stability studies leading to delays in the product regulatory filings. A well-designed stability protocol can result in significant savings during product development and after product approval. It is necessary to stay in touch with recent developments in the industry and the regulations to ensure that stability programs comply with current requirements and expectations.

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