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Risk-based Software Verification and Validation

Duration : 90 Minutes

John E. Lincoln,

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 38 years experience in U.S. FDA-regulated industries, 24 as an independent consultant. John has worked with companies from start-up to Fortune 100, world wide.  He specializes in quality assuranc Read more

FDA Warning Letters and recalls indicate major cGMP deficiencies in big name device and pharma companies, many centered around master / discrete V&V planning and execution.  What is V&V planning.  What really is a Master Validation Plan? Why do companies need one?   What is the discrete / individual V&V plan? It’s format and key components? What are the "must have" elements from ISO 14971 and ICH Q9 for hazard analysis and product risk management?  How can these be integrated?   What are the differences and similarities between Product, Equipment (production and lab/test), Process, and QMS V&V? Examples of specific, targeted Test Cases for each subject and each qualification (IQ, OQ, and PQ).  Software / firmware V&V consideration and integration into the plans / protocols. All information and formats have decades of field testing with the US FDA and EU Notified Bodies.

Course Objectives:

Software and related hardware design, development, verification and validation is difficult to manage, document and control.  This presentation focuses on the verification and validation planning and execution of software, after basic developmental testing and de-bug.  “Working” definition of terms, e.g., verification and validation. It includes COTS (commercial off-the-shelf)  and the growing field of "cloud"-based software.  A suggested 11-elements FDA model (mandated for submissions) will be evaluated, implemented, with V&V documentation and each type of test case examples.  The focus is on the most recent issues the FDA has had in this area, and remediation approaches.  Software considered: 1) In-product, 2) As-product, 3) Production / Test, and 4) QMS / 21 CFR Pt. 11.  Field examples, good and bad will be addressed. Evaluation of the chief areas of FDA concerns will focus on actual and anticipated changes in emphasis based on the changing regulatory climate. The information provided will allow the project leader to develop key milestones / tasks for a successful V&V project that have cleared numerous FDA and Notified Body reviews.

Why Should You Attend:

Both the U.S. FDA CGMPs and Guidance Documents and EU's MDD/MDR and standards require documented risk-based "master" and "individual" software V&V planning and execution with clearly documented Test Reports / Protocols.

Course Outline:

• Software verification or Validation – what is it in a real-world environment?
• Regulatory expectations.
• The Master and Individual Validation Plans.
• Roles of Verification and Validation.
• What Are, When / How to Use DQ, IQ, OQ, PQ, ASTM E2500 Equivalents; Part 11
• 11 FDA required V&V documents.
• A Typical Software V&V Protocol / Test Report; "Black" and "White" box
• Test case examples for each type of qualification.
• Using the Risk Management tools of ISO 14971 and ICH Q9 for “risk-based”.
• Product, process, equipment (production / test / lab), QMS  SW V&V.
• Legacy, Hybrid, New and ER / ES Systems.
• Compliance problems.

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Senior and Middle Management
• Validation teams
• Supervisors
• R&D
• Manufacturing Engineering
• Software Engineering
• Operations
• Marketing

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register


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Subject : Risk-based Software Verification and Validation

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