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FDAnews Announces Device Software Verification and Validation: Get Ready for a New Breed of Investigators, On-Demand Webinar, Aug. 12, 2014
Date:7/15/2014

Falls Church, VA (PRWEB) July 15, 2014

Device Software Verification and Validation:
Get Ready for a New Breed of Investigators
**FDAnews On-Demand Webinar**
Aug. 12, 2014 ? Any Time at Your Convenience
http://www.fdanews.com/DeviceSoftwareOnDemand

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.

Veteran FDA consultant John Lincoln explains what the FDA expects now, and how to achieve it in a hurry.

In a 90-minute in-depth chalk talk, Mr. Lincoln demonstrates 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 addresses 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 your 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 your 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 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 the 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, and Regulatory Affairs as well as Director of R&D. A prolific author, he writes a regular column for the Journal of Validation Technology.

Who Will Benefit
Here’s a suggested list of potential participants:

  •     Software development
  •     Programming, documentation
  •     Testing
  •     QA/RA
  •     R&D and engineering
  •     Manufacturing production and operations

Conference Details
Device Software Verification and Validation:
Get Ready for a New Breed of Investigators
**FDAnews On-Demand Webinar**
Aug. 12, 2014 ? Any Time at Your Convenience
http://www.fdanews.com/DeviceSoftwareOnDemand

Tuition
$487 per site -- includes webinar registration and audio cds and transcripts

Easy Ways to Register
Online:    http://www.fdanews.com/DeviceSoftwareOnDemand
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.

Read the full story at http://www.prweb.com/releases/FDAnews/DeviceSoftwareOnDemand/prweb12019361.htm.


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