Quality Control Laboratory Compliance - cGMPs and GLPs

Learning Objectives:
Key goals of the conference will include learning:

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.
Who will Benefit:
Senior directors, managers, supervisors and those who have responsibility for ensuring that QC laboratory operations and practices comply with current good manufacturing practices and good laboratory practices.

Quality Assurance
Quality Control
Research & Development