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TMCNet:  Research and Markets: Key GMP Systems in Pharmaceutical and Biotech Labs: 2-Day In-person Seminar - Philadelphia, January 29-30th, 2015

[August 19, 2014]

Research and Markets: Key GMP Systems in Pharmaceutical and Biotech Labs: 2-Day In-person Seminar - Philadelphia, January 29-30th, 2015

DUBLIN --(Business Wire)--

Research and Markets (http://www.researchandmarkets.com/research/6np8pv/key_gmp_systems) has announced the addition of the "Key GMP Systems in Pharmaceutical and Biotech Labs: 2-Day In-person Seminar" conference to their offering.

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 inspection. 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

FDA requirements for method validation

- Overview of relevant ICH guidances and USP chapters

- What are the requirements for different methods

- 483s related to method validation and lessons learned

Regulatory inspections

- How to prepare for regulatory inspections

- How to handle regulatory inspections

Who Will Benefit:

- QC chemists, supervisors and managers

- R&D chemists, supervisors and managers

- QA managers and personnel

- Regulatory affairs personnel

For more information visit http://www.researchandmarkets.com/research/6np8pv/key_gmp_systems


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