Key Topics
- Avoid complacency from past "good" FDA / ISO compliance
- Focus on key cGMP issues
- The major 21 CFR issues in 111, 210 / 211, and 820
- Developing the Annual Lesson Plan(s)
- How to address known problem areas during cGMP training
- Defect recognition
- Monitor and maintain `the edge`
- Stop unauthorized changes -- Prove `in control`
Who should Attend
QA, Senior management in Drugs, Devices, Biologics, Dietary Supplements, R&D, RA, Production, Engineering, Consultants; others tasked with project leadership responsibilities and Operations.
