Both the U.S. FDA and EU's MDR expect documented risk-based device test method and design Verification and Validation under U.S. FDA cGMP, EU MRD and ISO 14971
Review a company's Test Method and Design Verification and Validation system for major cGMP deficiencies. Address the FDA's newer and tougher regulatory stance. One major failing is 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 for hazard analysis and product risk management, allows the development of meaningful product quality-specific process validations, especially at the design stage (820.30). Also 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 where required.
Issues to be covered include:
Review a company's Test Method and Design Verification and Validation system for major cGMP deficiencies. Address the FDA's newer and tougher regulatory stance. One major failing is 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 for hazard analysis and product risk management, allows the development of meaningful product quality-specific process validations, especially at the design stage (820.30). Also 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 where required.
Why Should You Attend:
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in test method/device design verification and validations. What are the regulatory requirements? One major failing is lack of sufficient or targeted risk-based process V&V planning/execution. The 'must have' elements from ISO 14971 for hazard analysis and product/process risk management. Integration of test method validation essentials into a company's quality management system, specifically its design control activities.Areas Covered in the Webinar:
Participants will learn how an effective Test Method Validation system is a critical requirement to the movement toward a risk-based approach to compliance and product safety.Issues to be covered include:
- Assurance of product quality from CGMP test method compliant validation
- FDA Test Method V&V requirements
- Learn methods for developing process validations and best practices
- Understand the scope of regulations governing test method/design 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
Who Will Benefit:
This webinar will provide valuable assistance to all regulated companies that need to review and modify their Test Method/Device Design Validation Planning and Execution/Documentation. While this information is focused on Medical Devices, many of its principles apply to personnel/companies in the Pharmaceutical, Diagnostic, and Biologics fields. The employees who will benefit include:- Senior management
- R&D
- Quality Assurance/Regulatory Affairs
- Production
- Engineering, including Software
- All personnel involved in verification and/or validation planning, execution and documentation.
Course Provider
John E Lincoln,
