cGMP Refresher

Training Agenda

1. Introduction to cGMP and Regulatory Landscape_ Overview of cGMP requirements and its significance in the Life Science industry Key regulatory agencies and their role in enforcing cGMP compliance
2. Quality Systems and Documentation_ Understanding the essential components of a robust quality system Documentation requirements, including SOPs (Standard Operating Procedures), batch records, and validation protocols
3. Facility and Equipment Considerations_ Good Facility Design (GFD) principles for maintaining a compliant manufacturing environment Equipment qualification and calibration best practices
4. Materials Management and Control_ Supplier qualification and evaluation processes Proper handling, storage, and traceability of raw materials and finished products
5. Process Validation and Control_ Introduction to process validation and its importance in ensuring product quality and consistency Control strategies for critical manufacturing processes
6. Change Control and Deviation Management_ Change control procedures and the impact on cGMP compliance Handling and documentation of deviations and investigations
7. Training and Personnel Qualification_ Training programs for maintaining a knowledgeable and skilled workforce Qualification and training requirements for personnel involved in cGMP operations
8. Inspection Readiness and Post-Market Compliance_ Preparing for regulatory inspections and audits Post-market compliance considerations and surveillance activities
9. Interactive Q&A Session_ Open discussion and clarification of specific questions or concerns related to your organization's compliance challenges