FDAnews Announces — Device Software Verification and Validation: What Is Now Required Under ISO 13485:2016 Webinar, Oct. 31, 2016

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After 13 years of the same old, same old ISO 13485, the first major revision to the standard has been introduced. Join veteran FDA consultant, John Lincoln on Oct. 31 when he’ll demonstrate a preferred FDA 11-element documentation model in various applications including ERP, in-device, as-device, process/equipment control and cGMP data/Part 11 applications.

Device Software Verification and Validation:
What Is Now Required Under ISO 13485:2016
**An FDAnews Webinar**
Oct. 31, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/devicesoftwarevv

After 13 years of the same old, same old ISO 13485 — the first major revision to the standard has been introduced.

With it comes an added emphasis placed on validating the Quality Management Systems.

What are the expectations of FDA investigators? How can manufacturers meet those expectations?

Join veteran FDA consultant, John Lincoln on Oct. 31 when he’ll demonstrate a preferred FDA 11-element documentation model in various applications including ERP, in-device, as-device, process/equipment control and cGMP data/Part 11 applications.

After this 90-minute webinar attendees will come away with an understanding of:

  •     Validating QMS software
  •     Developing and creating buy-in for a project validation plan
  •     Understanding what the FDA accepts as an appropriate documentation model
  •     Beyond just in-product software V&V — understanding the FDA’s expectation for testing software, ERP software and more
  •     When and how to use DQ, IQ, OQ, PQ or their equivalents
  •     How GAMP 4/5 requirements fit into V&V planning and execution
  •     Detailing the FDA’s 11 key V&V documentation elements:

1.    Level of Concern
2.    Hazard/Risk Analysis
3.    Software Description
4.    SRS (Software Requirements Specification)
5.    Architecture
6.    Design Specification
7.    Traceability (Matrix; Paragraph Numbering)
8.    Development
9.    V&V (Verification/Testing & Validation: IQ, OQ, Part 11 test cases, if required, PQs)
10.    Revision History and Release Number
11.    Unresolved Anomalies ('Bugs')

  •     “White Box” and “Black Box” validations
  •     And much more

Register today for a clear understanding of FDA investigators expectations and how to meet them.

Meet the Presenter:
John Lincoln, Principal of J.E. Lincoln and Associates LLC
John Lincoln has nearly 20 years experience as an FDA consultant. As Principal of J.E. Lincoln and Associates LLC, John has worked with start-ups through Fortune 100 companies in the U.S., Mexico, Canada, France, German, Sweden, China, and Taiwan. John has held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, and Director of R&D. As a frequently published author, he also writes a column for the Journal of Validation Technology.

Who Will Benefit:

  •     QA/RA
  •     Software development, programming, documentation, testing
  •     R&D
  •     Engineering
  •     Production
  •     Operations    

Webinar Details:
Device Software Verification and Validation:
What Is Now Required Under ISO 13485:2016
**An FDAnews Webinar**
Oct. 31, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/devicesoftwarevv

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/devicesoftwarevv                            
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
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