Process Validation & Equipment Validation

Course details

Process Validation is required in the Pharmaceutical, API and Medical Device Healthcare Sectors. A comprehensive, well thought-out approach to validation is a key element in assisting any company meet European & US FDA regulatory inspection requirements. This course looks at regulatory guidances & recent trends in validation.

Learning Outcomes

On successful completion of this training course, delegates should be able to:

• Recognise the regulatory requirements for process validation
• Appreciate the benefits of conducting validation studies.
• Demonstrate an understanding of the key elements of process validation
• Appreciate European & FDA Guidance publications on process validation
• Determine where to use process capability and other statistical methods during validation studies
• Demonstrate an understanding of the approach adopted by the Global Harmonisation Task Force regarding verification and validation
• Design a validation master plan, validation protocols & reports
• Describe the main requirements for maintaining a state of validation

Course Programme

DAY 1

• Introduction
• Business Benefits of Process Validation
• Validation Regulatory Requirements & Guidelines
• Getting Started
• Validation Master Plan
• Validation versus Verification
• Exercise on validation versus verification
• Statistical Methods & Tools for Validation
• Risk Analysis
• ISO 14971 & Risk Assessment
• Equipment Qualification

DAY 2

• Cleaning Validation
• Product & Process Validation
• Case study (Determining what needs to be included in the VMP for a specific manufacturing process)
• Preparing a Validation Master Plan, Protocol & report
• Maintaining a state of validation
• Retrospective Validation
• Review of recent FDA enforcement action