For the Pharmaceutical Industry it verifies that each piece of equipment or system that enters into a drug’s “chain of custody" has been tested and qualified for use. Validations provide evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes. The FDA is a federal science-based law enforcement agency mandated to protect public health. The validation process is regulated by the guidelines and restrictions set forth by the FDA. However, the actual validation protocol, documentation, and execution is the responsibility of the manufacturer. More specifically, this is the responsibility of the engineer.
Objectives of the Presentation
- Installation Qualification (IQ) evaluates means of accommodating new equipment and testing its materials
- Operational Qualification (OQ) is essential in challenging your equipment parameters
- Performance Qualification (PQ) puts your equipment to the final test
Why Should you Attend
- What are IQ, OQ, PQ requirements - how and why are they performed?
- What are the "must have" elements from the cGMPs and best practices?
- How do you define and use IQ, OQ, PQ or their equivalents?
- Why do companies need robust Verification & Validation practices?
- How can these be integrated into the company's quality management system?
- ISO 14971 and ICH Q9 hazard analysis and product risk management factor in and allocating limited resources
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.
Does your company have a robust Verification and Validation System? Do you understand Good Manufacturing Practices and elements of cGMPs? Are they incorporated into your current Quality Management System? Do you - or your customer - define and use IQ, OQ, PQ, or their equivalents? Are company resources allocated in light of hazard analysis and product risk management factors?
Who will Benefit
- IQ, OQ, and PQ, major components of robust Verification and Validation programs - Regulatory requirements
- Product The Master Validation Plan(s)
- Individual V&V Plans and their execution
- 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
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 quality, verification and/or validation planning, execution and documentation
Validations provide evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes. The FDA has established guidelines on validation protocol, documentation, and execution - Installation Qualification, Operation Qualification, and Performance Qualification (IQ/OQ/PQ). It is the responsibility of the manufacturer, specifically the design engineer, to ensure that these validation qualifications have been performed and documented.