FDAnews Announces — Device Software Verification and Validation: Get Ready For A New Breed of Investigators Webinar, Jan. 6, 2016
Falls Church, VA (PRWEB) December 18, 2015 -- Device Software Verification and Validation:
Get Ready For A New Breed of Investigators
Jan. 6, 2016 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/devicesoftwareverificationandvalidation
Meet the FDA’s new software investigators. They’re armed — with IT knowledge — and are cracking down on medical devicemakers whose software doesn’t measure up.
It’s a crackdown for certain on device software verification and validation. The agency has hired a cadre of sophisticated enforcers, tough new inspectors trained in IT to recognize that software validation and documentation are the foundation for the safety of any device.
FDAnews has scheduled a learning session to get devicemakers ready for these inspectors’ visits. Mark the calendar for Wednesday, Jan. 6, when veteran FDA consultant John Lincoln takes the virtual stage to explain what the FDA expects now, and how to achieve it in a hurry.
In a 90-minute in-depth chalk talk, Mr. Lincoln will 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.
He’ll address use of FDA guidances, GAMP 4/5, 21 CFR 11, and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Risk Management models and their real-world implementation.
Attendees will come away with an actionable understanding of:
• 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 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 fits 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
Device Software Verification and Validation will give attendees a clear understanding of FDA inspector expectations and how to meet them, with a specific focus on software that is as-product, in-product, process and/or in overall manufacturing and operations. Why risk FDA sanctions, let alone multimillion-dollar liability lawsuits?
Meet Your Presenter:
John Lincoln has nearly 20 years’ experience as an FDA consultant. As Principal of J.E. Lincoln and Associates LLC, Mr. Lincoln has worked with companies from start-ups through Fortune 100 giants, in countries from the U.S. to Taiwan. He has held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, and Director of R&D. A prolific author, he writes a regular column for the Journal of Validation Technology.
Who Will Benefit:
• Software development
• Programming, documentation
• Testing
• QA/RA
• R&D and engineering
• Manufacturing production and operations
Webinar Details:
Device Software Verification and Validation:
Get Ready For A New Breed of Investigators
Jan. 6, 2016 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/devicesoftwareverificationandvalidation
Tuition:
$287 per site
Easy Ways to Register:
Online: http://www.fdanews.com/devicesoftwareverificationandvalidation
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.
Michelle Butler, FDANEWS, http://www.fdanews.com, +1 (703) 538-7665, [email protected]
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