Laboratory Inspection and Auditing

Topics

• The key steps in the analytical process
• Non-conformance to cGMP regulations in analytical operations
• The significance of pharmacopoeias in analytical operations
• Commonly-used analytical techniques and instruments
• The importance of GMP controls over analytical method suitability (validation, verification and transfer)
• The requirements for controlling reference standards, reagents and important consumables
• Current expectations for data integrity controls, including electronic data systems
• Analytical instruments according to quality risk and the qualification requirements for each class
• The regulatory requirements for reference and retention samples
• Non-conformances in the control of stability studies

Who should Attend

• Quality assurance professionals
• GMP auditors
• Quality management
• Laboratory managers