Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)

Topics

• Where does the Process Validation commence
• What FDA segments are included and excluded within the "NEW" Process Validation
• How Stage 1 integrates with Phase 1
• What are the Three Stages and Where Do They Apply within the NEW Process Validation
• The Statutory and Regulatory Requirements for Process Validation
• The Validation approaches that are included within this Guidance document
• The Phase 1 Investigational Drug Requirements -- What is and What is NOT Required
• An Introduction tPhase 1 Guidance for Industry and Its Application within the "NEW" Process Validation
• Regulatory Strategies for Phase 2 and 3 and their Incorporation within Stages 1 and 2
• General Considerations for Process Validation - Stage 2 Process Qualification
• A Review of EU Annex 15 and its Comparison tFDA`s Process Validation Guidance
• General Considerations for Process Validation - Stage 3 Continued Process Verification

Who should Attend

• Project Management
• Product Development
• Quality Assurance
• Regulatory Compliance
• Manufacturing and Facilities professionals
• Quality Control