Process Validation with Qualification

Process Validation with Qualification is a conference dedicated to the FDA and EU Process Validation Guidelines.

Topics

• Quality Risk Management
• Science and Risk Based Approach to Process Validation for Pharmaceutical and Biopharmaceutical Products
• EU Process Validation Guideline
• FDA Process Validation Guidance
• Lifecycle Approach to Process Validation
• EU Draft Annex 15
• Equipment and Utility Qualification
• Process Design
• Continued Process Verification/Ongoing Process Validation
• Process Performance Qualification/Process Validation
• Process Improvement
• Continued Improvement and Process Optimisation
• Business Benefits
• Implementation Challenges

Who should Attend

• Manufacturing attendees
• Development personel
• Quality managers
• Engineers
• Pharmaciss
• Process Engineers
• Quality Assurance Professionals
• Scientists
• Late Stage Product and Process Development Engineers, Scientists, Pharmacists
• Quality Control Managers
• Validation and Qualification Managers
• Technology Scale up and Transfer Managers
• Risk Management Specialists
• Validation and Qualification Specialists
• Operation Managers, Engineers
• Lean management Specialists