This 90-minute session on risk-based verification and validation planning will discuss "must have" elements from the U.S. FDA cGMP, EU MDR, ICH Q9, and ISO 14971 for hazard analysis and product risk management, and show how you can integrate these into a company's quality management system.
Why Should You Attend
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in verification and validations. And now the FDA is taking an even tougher stance. One major failing is the lack of sufficient or targeted risk-based process V&V planning/execution. Consider some basic principles in the FDA's Process Validation Guidance Document for pharma. The "must have" elements from ISO 14971( and ICH Q9) for hazard analysis and product/process risk management. Integration of process validation essentials into a company's quality management system.
This webinar will review the company's Process Verification and Validation system for major cGMP deficiencies. Address the FDA's newer and tougher regulatory stance, and its most recent Process Validation guidance upgrade (device principles from pharma). One major failing is the lack of sufficient or targeted risk-based V&V planning and associated documentation. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management allows the development of meaningful product quality-specific process validations.
It will also discuss the roles of different V&V protocols; how to employ equipment/process DQs, IQs, OQs, and PQs, or their equivalents. Our matrix examples simplify "as-product", in-product", process and equipment, et al, software VT&V, assuring key FDA requirements are not overlooked. The QMS and 21 CFR Part 11 and cybersecurity are considered.
Webinar Takeaway
Participants will learn how an effective Process Validation system is a critical requirement to the movement toward a risk-based approach to compliance and product safety. Also to be discussed is how to tackle process validation for medical device combination products.
- Assurance of product quality from CGMP-compliant validation
- Learn how to improve process system knowledge and understanding
- Learn methods for developing process validations and best practices
- Understand the scope of regulations governing process validation and identify gaps
- Develop a plan to rectify existing validation plans, protocols, and reports
- Learn how to construct, implement and deploy a Validation Master Plan
Speakers
John E. Lincoln,
Principal Consultant ,
J. E. Lincoln and Associates LLCJohn E. Lincoln is principal of J. E. Lincoln and Associates LLC, a consulting company, with over 33 years’ experience in U.S. FDA-regulated industries and 20 years as a full-time consultant. He has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan.
He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process/ product/ equipment including QMS and so+E6ftware validations, ISO 14971 product risk management files / reports, design control / design history files, and technical files. He's held positions in manufacturing engineering, QA, QAE, regulatory affairs, to the level of director and VP (R&D). In addition, Mr. Lincoln has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CGMP subjects. He is a graduate of UCLA.
Who Should Attend
This webinar will provide valuable assistance to all regulated companies that need to review and modify their Process Validation Planning and Execution/Documentation. While this information is focused on Medical Devices, its principles apply to personnel/companies in the Pharmaceutical, Diagnostic, and Biologics fields. The employees who will benefit include:
- Senior management
- Regulatory Affairs
- Quality Assurance
- Production
- Engineering, including Software
- All personnel involved in verification and/or validation planning, execution and documentation
