FDA's New Software Validation Requirements


Instructor: John E Lincoln
Product ID: 706952
Training Level: Intermediate to Advanced

  • Duration: 90 Min
CGMP companies must develop / implement formal software V&V for medical product under IEC 62304 and a key US FDA Guidance Document.
Last Recorded Date: Feb-2024


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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, documenting, and execution of software, used in medical device and drug 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) and based on IEC 62304 and a recently updated FDA Guidance 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. 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 the most recent changes in US FDA requirements.

Why Should You Attend:

Software V&V issues are becoming 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. A long time standard for software V&V has been IEC 62304 . See how this standard can be implemented in accordance with the US FDA's recently revised Guidance Document on 510(k) Submissions of Devices containing software which can be a model for all software V&V. In addition, 21 CFR 11 and cybersecurity are often important considerations for incorporation into many equipment or device validations. Growing "cloud" issues add urgency to upgrade control. Software's complex logic pathways mandate resource-intensive V&V activities, in a resource-constrained environment, demanding a risk-based approach. hat V&V is necessary to minimize software failures? Use the FDA's own "model" to document all types of SW V&V.

Areas Covered in the Webinar:

  • Tougher FDA Expectations / Requirements; Cybersecurity
  • Roles of Verification and Validation
  • IEC 62304 and an FDA Guidance

  • An FDA "Model" - 10 Documents
  • 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

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 driven, companies with quality management / MRP / ERP systems moving toward "paperless" systems, or other regulated medical products / CGMP and ISO QMS activities.

Instructor Profile:
John E Lincoln

John E Lincoln
Principal, J E Lincoln and Associates

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 41 years experience in U.S. FDA-regulated industries, 27 years as head of his own consulting company. John 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 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, 5 chapters in the RAPS textbook on validation, conducted workshops and webinars worldwide on CGMP subjects. John is a graduate of UCLA.

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