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.
Objectives of the Presentation
Why Should you Attend
- 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
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.
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.
Who will Benefit
- 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 to 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
This webinar will provide valuable assistance to all regulated companies that need to review and modify their company's planning and execution of verification and validation, based on a proper understanding of the roles of IQ, OQ, and PQ, or equivalent terminology. Its principles apply to personnel / companies in the Medical Devices, Pharmaceutical, Diagnostic, and Biologics fields. The employees who will benefit include:
- Senior management
- Middle management
- Research & Development
- QA / RA
- cGMP instructors
All personnel involved in verification and/or validation planning, execution and documentation.