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Pharmaceutical cGMP, Data Integrity and FDA Inspections a Current Challenges and Preparations

29th September 2016 - 30th September 2016
Mumbai, India


What are the Current Good Manufacturing Practice regulations (cGMP) for Finished Pharmaceuticals (cGMP)ya Why is it required to follow these regulationsya This seminar will provide a review of cGMP regulations with explanations that will demonstrate the benefits of complying with these simple rules.You will learn how to prepare for and what is the appropriate conduct during FDA Inspections. Acquire the suitable skills necessary for responding to FDAas questions. Descriptions of what records you have to provide and what records you should not provide to FDA. Learn how to write a procedure for preparing for FDA and other regulatory agency inspections.The importance of data integrity and control of electronic records, with particular regards for recent problems with Indian API manufacturers. A comprehensive review of having and following written laboratory investigation procedures. Providing and maintaining adequate audit trails for traceability to your original data.

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