IQ,OQ,PQ in the Verification and Validation Process
|Date||:||28th May 2019|
|Time||:||11:30 AM PST | 02:30 PM EST|
Validation is an important element of the Quality System Regulations and ISO 13485. This course will cover what processes needed to be validated and what steps you need to take to validate processes. You'll also learn the essentials of validation planning, protocol writing, and change management.
We'll also cover the steps of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices. This webinar will discuss the Consideration of IQ, OQ, and PQ and their equivalents for processes, equipment (production and test), product, and cGMP e-records / e-signatures.
Why Should You Attend:
Failure to validate is a significant cause of 483 observations. Even worse, it can result in customer complaints, adverse events, and even recalls. In this webinar, you'll learn how to avoid these problems and use validation concepts to ensure process stability and control. You'll learn the benefits and impacts of validation and how it can benefit your customers and your business. We'll cover tools and techniques that can help you successfully validate your processes.
Objectives of the Presentation:
- IQ, OQ, and PQ, major components of robust Verification and Validation programs - Regulatory requirements
- The Master Validation Plan(s)
- Individual V&V Plans and their execution
- Product Verification and Validation
- Process and Equipment V&V, including software
- QMS V&V and 21 CFR Part 11
- When / How to Use DQ, IQ, OQ, PQ
- Incorporating the Hazard Analysis / Risk Management tools of ISO 14971 or ICH Q9
Areas Covered in the Session:
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big-name device and pharma companies, many going back to insufficient, poor or non-existent product/equipment/ process V&V requirements and execution. And now the FDA is taking an even tougher stance.
- Why do companies need robust V&V
- What are the "must have" elements from the cGMPs and best practices
- How do you define and use IQ, OQ, PQ, or their equivalents
- How do ISO 14971 and ICH Q9 for hazard analysis and product risk management factor in and assist in allocating limited company resources
- How can these be integrated into the company's quality management system
- While focused on cGMP compliance, it is suitable for ISO 13485 and ISO 9001 (international/global) compliance as well
Who will Benefit:
- Senior Management
- Middle Management
- Research & Development
- QA / RA
- cGMP Instructors
Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with an emphasis on quality, compliance, and six sigma. She has worked at industry leading companies such as GE, J&J, and Medtronic with an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She is a Presidential Scholar with a BS in Biomedical Engineering and an MBA from the University of New Mexico. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and is a CQA (Certified Quality Auditor) from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.