11:00 AM - 03:00 PM
GMPs – Government Regulations

- What are the regulations governing Good Manufacturing Practices?
- Your responsibilities
- Pertinent GMP topics as per the code of Federal Regulations
- Quality Management
- Personnel
- Premises and equipment
- Documentation
- Production
- Quality Assurance
- Materials management
- Production and in-process controls
- Packaging and labeling
- Storage and distribution
- Laboratory controls
- Validation
- Change control
- Rejection and re-use of material
- Complaints and recalls
- Supplier controls

11:00 AM - 03:00 PM
GMP Inspections

– Preparing for a GMP Inspection
– The consequences of not being ready
– The specific areas that are inspected during a GMP inspection

11:00 AM - 03:00 PM
GMP Inspections

- The FDA Inspection – how is it structured and conducted
- Responding and organizing for the FDA Inspection
- Importance of truthfulness
- Importance of knowledgeability and confidence
- FDA Tricks to elicit information
- Arguing and challenging
- Behavior during the inspection
- Importance and role of documentation
- Effective communication skills
- Being deceptive
- Opinion versus fact
- Phrases never to say
- Handling adverse findings during the inspection