Quality Control Laboratory Compliance - cGMPs and GLPs

Topics

• 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 should Attend

Senior attendees from:

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