Stability Programs - Key Factors in Meeting FDA/ICH Expectations

Date: February 14, 2017
Time: RECORDED SESSION
Duration: 90 Minutes - Online
Price: $299 - Includes Bonus Handouts!

Course Description:

Stability testing is mandatory as part of cGMP to demonstrate a pharmaceutical product meets its acceptance criteria throughout its shelf life.  A sustainable stability program in compliance with current regulations is therefore critical to development of new pharmaceutical products.  ICH Guideline Q1A (R2) contains harmonized expectations for global stability submission.  Although sometimes confusing and contradictory, FDA and ICH mandates must be considered in tandem to gain market approval

The objective of this interactive 90-minutes online course is to provide you with an overview to establish an effective and compliant stability program for pharmaceuticals and biopharmaceuticals.  Discussion will include a thorough review of US FDA cGMP regulations/ICH Stability guidelines, development stability testing protocol supporting global markets, and strategies to minimize redundant testing for resource saving.

By attending this course, you will learn:

  • How to interpret FDA cGMP regulatory requirements for stability testing
  • The role of the Stability Program during the drug development process
  • Essential activities for Drug Product and Drug Substance/API stability programs
  • Impact and proper use of ICH Guidelines in Stability Programs
  • How to review FDA Warning Letters and 483s to enhance and maintain compliance
  • How to keep your stability knowledge up to date

This course will be of benefit to methods development scientists and project managers, Stability Group scientists and managers, QC analysts, laboratory managers, validation specialists, QA managers and staff, and anyone involved with regulatory affairs and GMP Laboratory Control Systems compliance. In addition, this course is extremely useful for both sponsor and CROs (e.g. Contract Research 

Judy Carmody

Judy Carmody, Ph.D., is the founder and Principal Consultant of Carmody Quality Solutions, LLC., a dynamic, innovative consulting agency that provides Quality services to the pharmaceutical, biologics and medical device industries.  

Dr. Carmody is the former president of Avatar Pharmaceutical Services, a GMP CRO which she founded and led for over 8 years, prior to selling it in 2010. Since then she has held senior level positions in small and large pharma and has strengthened her knowledge of robust quality systems. With each custom-crafted solution she fulfills her vision of connecting everyday quality processes and procedures with the strategic needs of her client's business.

Prior to founding Avatar, Dr. Carmody spent 10 years in the (bio)pharmaceutical industry, developing methods for small molecules and oligonucleotides, managing QC, Analytical, and Validation groups. In addition to this solid grounding in pharmaceuticals, she worked at Waters Corporation's Applied Technology and Marketing groups where she developed novel separations methods with colleagues and (bio)pharmaceutical customers. At Waters, Dr. Carmody brought numerous new technologies to market through published papers and technical presentations both at world-wide conferences and leading (bio)pharmaceutical companies.
Scientific understanding underscores Dr. Carmody’s unique approach to solving the most challenging Quality or Analytical issues. A resume that spans roles in applied technology, marketing, bench chemistry, validation, quality management and several leadership roles provides the basis of Dr. Carmody’s approach to solution building. Her experience leverages the creative integration of technologies from diverse fields and enables these elements to be transformed into client solutions. 

Dr. Carmody holds a PhD in Analytical Chemistry from Clark University in Worcester, Massachusetts.