The Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation) 2016 is a seminar that covers topics such as:
- What FDA segments are included and excluded within the "NEW" Process Validation
- Why these FDA Guidance for Industry/EU Guidelines - Process Validation is so important to the pharmaceutical and biotechnology industry
- What are the Three Stages and Where Do They Apply within the NEW Process Validation
- Where does the Process Validation commence
- The Validation approaches that are included within this Guidance document
- How Stage 1 integrates with Phase 1
- An Introduction to Phase 1 Guidance for Industry and Its Application within the "NEW" Process Validation
- The Statutory and Regulatory Requirements for Process Validation
- General Considerations for Process Validation - Stage 2 Process Qualification
- The Phase 1 Investigational Drug Requirements -- What is and What is NOT Required
- General Considerations for Process Validation - Stage 3 Continued Process Verification
- Regulatory Strategies for Phase 2 and 3 and their Incorporation within Stages 1/2
- A Review of EU Annex 15 and its Comparison to FDA`s Process Validation Guidance
The Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation) 2016 brings together senior attendees from:
- Microbiology Professionals
- Facilities
- Quality Control personnel
- Quality Assurance personnel
- Research & Development
- Regulatory Affairs Professionals
- Auditors
- Validation
