Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation) is a conference that covers topics such as:
- 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
Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation) brings together:
- Project Management
- Product Development
- Quality Assurance
- Regulatory Compliance
- Manufacturing and Facilities professionals
- Quality Control
