Verification and Validation - Planning and Execution

Topic Background:

Both the U.S. FDA and EU's MDR expect documented risk-based V&V under U.S. FDA cGMPs, the EU MDR, ICH Q9 and ISO 14971

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 lack of sufficient or targeted risk-based V&V planning / execution. Consider some basic principlses in the FDA's various guiidance documents on Validaiton. A softawre V&V "model" will be presented. The "must have" elements from ISO 14971( and ICH Q9) for hazard analysis and product / process risk management. Integration of validation essentials into a company's quality management system.

Description:

Review a company's Verification and Validation system for major cGMP deficiencies. Address the FDA's newer and tougher regulatory stance, and it's most recent Process Validation guidance upgrade (device principles from pharma). 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 and ICH Q9 for hazard analysis and product risk management, allows the development of meaningful product quality-specific process validations. Consider Human Factors / Use Engineering elements where required. 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, equipment and process software, assuring key FDA requirements are not overlooked. The QSR/QMRS/ISO 13485 and 21 CFR Part 11 and cybersecurity are all considered.

Areas Covered:

Participants will learn how an effective 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.

Issues to be covered include:

• Assurance of product quality from CGMP compliant validation
• Prospective, Concurrent, or Retrospective Validations
• Learn how to improve process system knowledge and understanding
• Learn methods for developing validations and best practices
• Understand the scope of regulations governing validation and identify gaps
• Develop a plan to rectify existing validation plans, protocols and reports; the use of "working definitions"
• Learn about Product, Process, Production / Test Equipment V&V
• Learn how to construct, implement and deploy a Validation Master Plan
• Compile a Compliant V&V Test Report with Various Test Cases