GMPs for All Phases - Ensuring GMP Compliance - 2018 Workshop by Ex-FDA Official

Topics

• Raw material requirements and process development
• Core principles of GMP Regulatory requirements across phases
• SOPs
• Quality Assurance Required
• Manufacturing process development & scale-up
• Batch records
• Qualification vs. Validation
• Method development
• Validation Requirements across regions & phases of study
• Discussion & Review: Qualification vs. Validation
• Vendor Management & Oversight
• Vendor selection & management
• SOP Development & Evolution
• Training Requirements
• Life cycle management considerations; document granularity
• Quality & Manufacturing Content Requirements for the IND/CTA/INDS – in CTD format
• Considerations for Setting specifications and expiring / re-test dates

Who should Attend

Senior attendees from:

• Quality Control Departments
• Quality Assurance Departments
• Regulatory Affairs Departments
• Manufacturing Departments
• Documentation Departments
• Production Departments