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.
Software/ firmware design and development is under increased scrutiny by the new tougher U.S. FDA. Recently a major pharma company paid a $750 M fine for poor compliance, and software V&V was one of the key contributors.
Product, production/ test equipment, and even the QMS are heavily software/ firmware driven in today's manufacturing. A comprehensive, corporate wide plan is a necessity. Growing cloud issues add urgency to upgrade control. Software's complex logic pathways mandate resource-intensive V&V activities, in a resource-constrained environment. Risk-based software documentation is the answer. What are the best approaches for companies to take? How can tougher FDA expectations be met? What V&V is necessary to minimize software failures in the field or in-house? How to bring software V&V in under budget and within project timelines?
John E. Lincoln,
J. E. Lincoln and Associates
John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 29 years experience in U.S. FDA-regulated industries. 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, 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.
This information applies to personnel / companies in the pharmaceutical, medical device, diagnostic, nutraceutical and biologics fields. Employees who will benefit include:
- Senior management
- Regulatory affairs
- Quality assurance / QAE
- Software development and testing teams
- All personnel involved in a U.S. FDA-regulated environment
- Those involved in new product development with products and equipment that are software driven
- Companies with quality management / MRP / ERP systems moving toward paperless systems or other regulated medical products activities