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Medical Device Non-Product Software Validation Training

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

This presentation focuses on the verification and validation planning and execution of software, used in medical device manufacturing, after basic developmental testing and de-bug. It includes COTS (commercial off-the-shelf), custom, and the growing field of "cloud"-based software. A suggested FDA model (mandated for submissions) will be evaluated, implemented, with V&V documentation and test case examples. The focus is on the most recent issues the FDA has had in this area, and remediation approaches. Software considered: 1) Production / Test, and 2) QMS / 21 CFR Pt. 11, and 3) Cybersecurity / Networked systems. Examples will be demonstrated. Evaluation of the chief areas of FDA concerns will focus on actual and anticipated changes in emphasis based on the changing regulatory climate.

Why Should You Attend:

Software design, development, implementation and use is under increased scrutiny by a "tougher" U.S. FDA. Software V&V issues are becomming a growing area of concern by regulatory agencies. Product production / test equipment, and even the QMS are heavily software / firmware driven in today's manufacturing. Part 11 and cybersecurity are often important considerations. A comprehensive, corporate wide plan is a necessity. Growing "cloud" issues add urgency to upgrade control. Software's complex logic pathways mandate resourse-intensive V&V activities, in a resource-constrained environment, demanding a risk-based approach. What are the best approaches for companies to take? How can tougher expectations be met? What V&V is necessary to minimize software failures? Use the FDA's own "model" to document all types of SW V&V. And use this model to add predictability to bring software V&V in under budget and within project timelines.

Course Outline:

• Major areas of industry failure

• Tougher FDA Expectations / Requirements; Cybersecurity

• Roles of Verification and Validation

• An FDA "Model"

• A Typical Software V&V Protocol / Test Report; "Black" and "White" box

• A Brief Overview of 21 CFR Part 11, and its implementation

• Legacy, Hybrid, New and ER / ES Systems

• Expected Regulatory Deliverables

• Cybersecurity

What You Get:

• Training Materials

• Live Q&A Session with our Expert

• Participation Certificate

• Access to Signup Community (Optional)

• Reward Points

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies in evaluating their existing or anticipated device production software / firmware V&V activities and documentation requirements, especially in light of the changes in the FDA's stance vis a vis industry compliance, past problems, and the growing "cloud" environment. It will help attendees understand and recognize the most common software V&V failings and their fixes. The webinar will allow attendees to develop and use a repeatable software V&V template for all software production equipment and process validation projects. This information applies to personnel / companies in the Medical Device and some Combination fields. The employees who will benefit include:

• Senior management

• Regulatory Affairs

• Quality Assurance / QAE

• Production

• Engineering, R&D, and software development and testing teams

• All personnel involved in a U.S. FDA-regulated environment. Especially those involved in new product development with products and production / test equipment that are software    

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

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