Navigation Links
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.


'/>"/>
Source: PRWeb
Copyright©2014 Vocus, Inc.
All rights reserved

Related medicine news :

1. FDAnews Announces The FDA Unique Device Identification (UDI) Rule Virtual Conference
2. FDAnews Management Report: Managing Contract Manufacturers and Testing Labs
3. FDAnews Management Report: Implementing Risk-Based Verification and Validation
4. FDAnews Announces CDRH’s Office of Compliance Reorganization: A “One-On-One” with Office Director Steve Silverman, Webinar, Feb. 5, 2014
5. AFAR announces the 2012 Hartford Centers of Excellence in Geriatric Medicine awards
6. Bascom Palmer Eye Institute announces breakthrough for degenerative vision disorder
7. University of Houston Graduate College of Social Work announces partnership with MD Anderson
8. The Ludwig Institute for Cancer Research announces launch of iTeos Therapeutics SA
9. AGA announces prestigious awards recognition recipients
10. TheBestHeartRateMonitorReviews.com Announces The Top 3 Heart Rate Monitors
11. Article Marketing Company Content Writing King Announces Training Of New Graphic Design Artist
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/11/2019)... ... 2019 , ... Women’s Excellence is excited to announce the opening of their ... Suite 103, Royal Oak, MI 48073 in the heart of Royal Oak off Woodward ... services in a contemporary, spa-like atmosphere. We are thrilled to be in a ...
(Date:9/11/2019)... ... September 10, 2019 , ... Episcopal Relief & ... vulnerable communities impacted by Hurricane Dorian. , In partnership with the Episcopal ... of Georgia, and the Episcopal Farmworker Ministry, Episcopal Relief & Development is giving ...
(Date:9/9/2019)... ... September 09, 2019 , ... Sharon, the respected Practice Administrator ... of Dental Office Management (AADOM) Annual Conference. This year, esteemed dentist, Dr. Patrick ... is Sharon’s third nomination in a row. The entire team at Cieplak Dental ...
(Date:9/9/2019)... NEW YORK (PRWEB) , ... ... ... Center of NYC ( https://www.orthodonticscenternyc.com ) located on the Upper East Side ... division to their busy orthodontic practice. The pediatric orthodontic division specializes in ...
(Date:9/8/2019)... ... , ... The reviews from patients of ABM Medical Clinic who have had ... pain free fat loss system, has patients booking their sessions and recommending this procedure ... state of the art technology incorporating radio frequency and heat to rid the fat ...
Breaking Medicine News(10 mins):
(Date:9/11/2019)... ... September 11, 2019 , ... ... today the launch of Annatto-GG™ 150 , a revolutionary compound that supports ... (geranylgeraniol), a patented form found in nature through the annatto plant, it’s a ...
(Date:9/11/2019)... , ... September 11, 2019 , ... Abilene Christian University ... of Nursing Practice (DNP) degree. The online BSN to DNP program pathway is meant ... Bachelor’s of Science in Nursing (BSN) degree to a Doctor of Nursing Practice degree. ...
(Date:9/11/2019)... ... 2019 , ... This event is free and takes place on Saturday, September ... 4 p.m. The Foundation for Senior Services Wellness Expo will feature entertainment and educational ... in a variety of fields. , The mission of the Foundation for Senior ...
Breaking Medicine Technology: