91AV

Introduction

This workshop will provide the audience with an overview of the key systems which have been mentioned by FDA inspectors as major areas of concern in FDA regulated pharma laboratories.

Course Description:
This workshop will provide the audience with an overview of the key systems which have been mentioned by FDA inspectors as major areas of concern in FDA regulated pharma laboratories. The topics addressed will include FDA requirements for OOS investigations, equipment program, pharmaceutical and biologics stability programs, method validation and handling regulatory inspections. During the discussion of each of the areas listed below, the workshop participants will work through a series of related FDA 483s to fully understand FDA expectations and the errors which lead to the 483s.

FDA requirements for the equipment program

Equipment qualification
Equipment operation and maintenance
FDA requirements for pharmaceutical and biologics stability programs

Overview of ICH and WHO requirements for stability programs
What are the stability study requirements for Phase I, Phase II and Phase III clinical studies
Stability methods and specifications
483s related to stability programs and lessons learned

Note: Use coupon code 232082 and get 10% off on registration

Useful links

Speakers

• Nanda Subbarao Dr. Nanda Subbarao 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. She has extensive experience in evaluation of analytical methods and method validation for products ranging from pre-clinical to clinical and commercial phases. Her hands-on expertise also covers setup of cGMP/GLP complaint quality systems for laboratory and stability programs as well as upgrade of existing quality systems for products during development and commercial phases. She serves on the American Association of Pharmaceutical Sciences, Stability Focus Team Steering Committee., United States

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Venue

Philadelphia, PA

Philadelphia, PA, Philadelphia, PA, Philadelphia, PA, 19019, United States

Organised by

ComplianceOnline At ComplianceOnline, we are focused on: Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety. Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns. Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally. Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.

Contact information

Chandrakala R
ComplianceOnline
+1-650-620-3915
Contact us by email

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