CGMP companies must develop/implement formal software V&V for medical products under IEC 62304 and a key US FDA Guidance Document.
Software and related hardware design, development, verification, and validation are 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 debugging. 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, 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 the US FDA requirements.
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.
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:
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.
John E. Lincoln is the Principal of J. E. Lincoln and Associates, a consulting company with over 41 years of experience in U.S. FDA-regulated industries, 27 of which as head of his own consulting company. John has worked with companies from start-ups 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, FDA responses, new/changed product 510(k)s, process/product/equipment incl+D33uding QMS and software validations, ISO 14971 product risk management files/reports, Design Control / Design History Files, Technical Files. He's held Manufacturing Engineering, QA, QAE, and Regulatory Affairs positions at the Director and VP (R&D) levels. In addition, John has prior experience in the military, government, electronics, and aerospace. He has published numerous articles in peer-reviewed journals, including 5 chapters in the RAPs validation textbook, and conducted workshops and webinars worldwide on regulatory issues. John is a graduate of UCLA.