2021 - Quality Control Laboratory Compliance - cGMPs and GLPs
Date2021-01-13 - 2021-01-14
Deadline2021-01-03
VenueVirtual Seminar, USA - United States
KeywordsQc lab regulations; Fda lab regulations; Lab compliance training
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.
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.
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Last modified: 2020-12-07 21:02:21