Process Validation Guidance Requirements (FDA and EU Annex 15: Qualification and Validation) 2016

Key Topics

• 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

Who should Attend

Senior attendees from:

• Microbiology Professionals
• Facilities
• Quality Control personnel
• Quality Assurance personnel
• Research & Development
• Regulatory Affairs Professionals
• Auditors
• Validation