Efficient Process Validation Strategies and Validation Master Plan (VMPs) for Medical Devices 2017

Topics

• Regulatory requirements, industry practice, and associated guidance documents relevant to process validation
• When and why validation is required
• The components of a good validation strategy
• The consequences of not validating or doing it poorly
• Successful validation master plans
• Application of problem solving methods to help asses which strategy is best in various situations
• Write a comprehensive protocol
• Requirements for validation documentation
• IQ/OQ/PQ validation sequence
• Common statistics for sound results
• When revalidation is needed
• Ongoing process monitoring and control requirements

Who should Attend

• Compliance professionals
• Quality professionals
• Auditors
• Production supervisors
• Design/development engineers
• Manufacturing engineers
• Quality engineers
• Process owners