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Software Validation and its 11 Key Documents - Webinar

  • ID: 4899592
  • Webinar
  • April 2019
  • Region: Global
  • 90 Minutes
  • Compliance Online
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Why Should You Attend:

Software design and development is under increased scrutiny by a "tougher" U.S. FDA. 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 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, demanding a product risk-based approach. 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? Use the FDA's own "model" to document all types of SW V&V. And use this model to add predictability to bring software V&V in under budget and within project timelines..

Areas Covered in the Webinar:

Major areas of industry failure
Tougher FDA Expectations / Requirements; Cybersecurity
Roles of Verification and Validation
An FDA "Model"
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
Complementary Guidelines
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John E. Lincoln is principal of J. E. Lincoln and Associates LLC, a consulting company with over 31 years’ experience in U.S. FDA-regulated industries, and 17 years as a full-time consultant. Mr. Lincoln 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, and technical files. He's held positions in manufacturing engineering, QA, QAE, regulatory affairs, to the level of director and VP (R&D). In addition, Mr. Lincoln 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. Mr. Lincoln is a graduate of UCLA.
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