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. IQ/OQ/PQ validations deliver 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.
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.
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
Objectives of the Presentation
- 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
Why Should you Attend
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?
- 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
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.
Mr Kenneth Zabel,
Compliance Auditor ,
Kenneth Zabel is a high energy, resourceful, creative problem solver whose skills enable manufacturers of automotive, aerospace, heavy equipment, medical, commercial food equipment, and other manufacturers achieve a competitive edge and maintain highest quality standards. Prior to focusing on quality and social compliance auditing, Ken developed and expanded the Global Food Equipment Sanitation Certification Programs of commercial food equipment against NSF/ANSI public health safety standards at NSF International, Intertek/ETL Semko, and CSA International. Ken has conducted risk analyses of medical device suppliers who had not completed supplier validations for their special processes.
Today Ken conducts SMETA, SA8000, WRAP, AIAG Sustainability and customer-specific audits for Asia Inspection, SGS North America, Samsung, KOHL'S, JC Penny, ALDO, Amazon, Walmart, Mattel, Fashion Angels, and ELEVATE as well as electrical safety audits for NSF International.
Who will Benefit
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