Risk-Based Software Verification and Validation

Instructor: John E Lincoln
Product ID: 701461
Training Level: Intermediate
  • Duration: 80 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Oct-2009

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367


Read Frequently Asked Questions

This software verification and validation training / webinar will discuss and address software verification and validation issues and their documentation to meet regulatory / cGMP expectations, reducing the risk of 483 observations and Warning Letters.

Why You Should Attend:
Software design and development is coming under increased U.S. FDA scrutiny, and with good reason. Increasingly, product, production and test equipment, and even the quality management system are software driven. Software's inherent complexity makes V&V activities time and money intensive, in an increasingly resource-constrained environment. What is the way out? How can be the desired results achieved, safe and effective products be developed and manufactured that meet regulatory expectations / requirements, as well as project dates and budgets?

Software (and its related hardware) design, development, verification and validation is difficult to manage, document, and control. This presentation focuses on the verification and validation of software after basic developmental testing and de-bug and includes COTS (commercial off-the-shelf) software. A suggested FDA model will be developed with examples of implementation. Risk-based software V&V will be discussed. The focus will be on recent issues the Agency has had with software V&V and suggested methods of remediation. Areas of concern to be addressed are: 1) Software "in product", 2) software "as product", 3) production and test equipment software, and 4) QMS software. The webinar will be presented using field examples, both good and bad.

It will help attendees understand, how to recognize the most common industry problems and likely system failure sources / locations, and prevent or correct. Develop and use a repeatable V&V template.

Areas Covered in the seminar:

  • FDA Expectations / Requirements.
  • Complementary / Alternative Guidelines, e.g., GAMP.
  • Verification and Validation.
  • One "Model" and its Implementation.
  • A Brief Overview of 21 CFR Part 11.
  • The CMM.
  • Legacy, Hybrid, and ER/ES+D33 Systems.
  • Expected Regulatory Deliverables.

Who will benefit:

This Risk based validation verification webinar applies to personnel / companies in the Pharmaceutical, Medical Device, Diagnostic, and Dietary Supplement, but the principles apply to all industries, regulated or not. The employees who will benefit include:
  • Senior management
  • Regulatory Affairs
  • Quality Assurance
  • Production
  • Engineering

Instructor Profile:
John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 28 years experience in U.S. FDA-regulated industries. John has worked with companies from start-up o 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 software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).

In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. John is a graduate of UCLA.

Follow us :
Seminars by Ex-FDA Officials
Critical Vendor Risk Management

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email call +1-888-717-2436 (Toll Free).

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