This Validation training will set forth the regulatory requirements for process validation, and will also include definitions and application of applicable terminology, and hints and recommendations for the more common types of process validation.
It is the goal of every manufacturing firm to maximize profit. This is often accomplished by process automation. Domestic and international regulations contain the requirements to verify that the process yields output that is both safe and effective, and meets all requirements. These requirements are also applicable to manual, “un-automated” processes.
This webinar will set forth the regulatory requirements for process validation, and will also include definitions and application of applicable terminology, and hints and recommendations for the more common types of process validation. These recommendations will address the challenges most commonly experienced during validation. Also covered will be the validation technique used for processes that are already in place.
Areas Covered in the Session :
- What is Validation?
- When should it be used?
- Validation vs. Verification: Which One?
- Different types of validation: Advance, retrospective, and concurrent
- Protocol preparation.
- Different types of validation.
- IQ, OQ, and PQ.
- Case studies and examples.
Who Should Attend:
- Research and Development Departments
- Quality Departments
- Process and Quality Engineers
- Regulatory Affairs Departments
- Quality System Auditors
Course Director: JEFF KASOFF
Jeff Kasoff, RAC, CMQ/OE, LBB, is the Principal at Lean to Quality, LLC. He has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from startup to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes.
Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff has the following certifications: Manager of Quality and Organizational Excellence certification from ASQ, Regulatory Affairs Certification from RAPS, and Lean Black Belt from IIE.