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

Training CD

One CD is for usage in one location only.
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CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-565-8542


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.

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