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Drafting a Software Verification and Validation Report Package and Protocol - The 11 Must-have Documents

Tuesday June 19 2018  10:00 AM PDT | 01:00 PM EDT

Training Duration = 90 Min                    Sponsored by Compliance Online

Click Here to register $349.00

Click Here to register and receive recording $199.00

A tougher U.S. FDA expects a company to maintain certain documents in equipment, process and product software V&V. These documentation requirements can assist in a 21 CFR Part 11 CGMP records / signature V&V as well.

This training program will provide valuable assistance to all regulated companies in evaluating their existing or anticipated software 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 validation projects.

Why Should You Attend:

Software and related hardware design, development, verification and validation is difficult to manage, document and control. This presentation will focus on the documentation required by the U.S. FDA for the verification and validation planning and execution of software after basic developmental testing and de-bug. It includes COTS (commercial off-the-shelf) and growing cloud-based software.

A suggested field-tested 11-element FDA model will be evaluated, implemented, with V&V documentation and test case examples. The focus of the webcast 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 and 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.

Areas Covered

  • Major industry failures
  • Tougher FDA expectations / requirements
  • Roles of verification and validation
  • The 11-element FDA model - and where it's required
  • A typical software V&V protocol / test report
  • A brief overview of 21 CFR Part 11, ER / ES
  • Legacy, hybrid, new, and cloud systems
  • Expected regulatory deliverables
  • Complementary guidelines, e.g., GAMP


John 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.