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2020 - Quality Control Laboratory Compliance - cGMPs and GLPs

Date2020-04-16 - 2020-04-17


VenueVirtual Seminar, USA - United States USA - United States

KeywordsQC Lab regulations; FDA lab regulations; Stability studies


Topics/Call fo Papers

The basics of FDA law and regulations governing QC laboratories responsible for testing research materials, components of FDA-regulated products, and finished FDA-regulated products (pharmaceuticals, biologics, medical devices, cosmetics, and foods).
Laboratory organization, personnel qualification and training requirements.
Documentation and record-keeping requirements, including e-records and data integrity.
Sample integrity requirements.
Management and control of stability (shelf-life) studies.
Analytical methods verification and validation.
Management and control of laboratory instruments.
Management and control of laboratory supplies.
Proper conduct of laboratory investigations.
Consequences of laboratory non-compliance.

Last modified: 2020-03-25 23:41:15