Navigation Links
FDAnews Management Report: Implementing Risk-Based Verification and Validation
Date:12/19/2013

Falls Church, VA (PRWEB) December 19, 2013

Implementing Risk-Based Verification and Validation
**FDAnews Management Report**
http://www.fdanews.com/RiskBased

Switching to risk-based verification and validation is likely to save drug and devicemakers money on projects, plus reduce liability and recalls.

It’s a good business idea. And what’s more, the FDA is pushing companies to do it.

But like any basic change, there’s a learning curve.

This all-new management report from FDAnews is just the ticket for drug and device manufacturers ready to take the first step … and seeking a helping hand.

The author, consultant John E. Lincoln, has more than 30 years of experience assisting drug and device manufacturers to design new products, pilot them, set up production, validate and bring them to market.

Implementing Risk-Based Verification and Validation begins with the basics — understanding what risk-based V&V is — then shows how to start implementation. Readers will discover:

  • Validation and verification basics
  • Master validation planning and product risk
  • Design qualification, installation qualification, operational qualification and performance qualification
  • Software validation and verification under 21 CFR Part 11
  • Product life cycles and validation
  • Quality System Regulation under 21 CFR 820 and ISO 13485
  • And much more

When FDA-regulated companies fail to do the basics of V&V, warning letters and Forms 483 often follow. Shifting to risk-based V&V helps keep drug and devicemakers on the FDA’s good side. All companies have to make the switch sooner or later. Why not start now? Order Implementing Risk-Based Verification and Validation.

About the Author:
John E. Lincoln is a partner at J.E. Lincoln and Associates. With a background in engineering, R&D, manufacturing, QA and regulatory affairs, he has more than 30 years of working in FDA-regulated industries under his belt. His experience includes designing, piloting, setting up production, validating and bringing drugs and devices to market.

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

  • Validation specialists
  • QMS managers
  • Product/Process/Equipment managers
  • Product/Process/Equipment testers
  • Computer system operators
  • GMP auditors
  • Project managers
  • Risk managers
  • Compliance officers
  • Training personnel
  • Service providers
  • Software developers

Management Report Details:
Implementing Risk-Based Verification and Validation
**FDAnews Management Report**
http://www.fdanews.com/RiskBased

Format: Print or PDF
Price: $397

Easy Ways to Order
Online: http://www.fdanews.com/RiskBased
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/RiskBased/prweb11434431.htm.


'/>"/>
Source: PRWeb
Copyright©2012 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. In children born with severe heart defect, surgical management has little effect on neuro outcomes
4. Moffitt researcher publishes book on nutritional management of cancer treatment effects
5. Study finds overmanagement of benign breast disease
6. New biospecimens management system in development
7. 53 million Americans might have diabetes by 2025, according to a new study in Population Health Management
8. Rutgers leads effort to replicate care management programs in 4 U.S. cities
9. NOVAtime Solutions to be showcased at Booth #1821 in the upcoming Society for Human Resource Management (SHRM) Annual Conference and Exposition
10. Funding for teacher classroom management study
11. Does Stress Management Slow MS?
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/23/2017)... Segundo, CA (PRWEB) , ... March 23, 2017 ... ... Verisys FACIS Monthly Monitoring Healthcare products at competitive pricing. Verisys ... source sanctions, Exclusions, Debarments, License restrictions and Disciplinary actions. , “We are delighted ...
(Date:3/23/2017)... ... March 23, 2017 , ... On 2 March 2017, the ... Special Operations Command’s Patriot Award. The award was presented by the USSOCOM Commander, ... Foundation for its significant and enduring support to the command. , Accepting ...
(Date:3/23/2017)... ... , ... News Advisory/Interview Opportunity , After six years of advocacy, testimony and ... for public health and the environment and is calling on the United States to ... overwhelming support of European citizens, the European Union (EU) will, beginning next year, ban ...
(Date:3/23/2017)... ... March 23, 2017 , ... ... HealthiPASS, an innovative patient - centric payment system, to expand its focus on ... in the patient financial experience. , “At Ogden Clinic, we are working ...
(Date:3/23/2017)... , ... March 23, 2017 , ... ... announced the publication of “Profiling protein expression in circulating tumor cells using microfluidic ... describes the use of the Vortex technology to capture CTCs and ...
Breaking Medicine News(10 mins):
(Date:3/22/2017)... , 22 de marzo de 2017   ... líder de soluciones de productos y servicios para ... que ha adquirido EPL Archives, Inc., una organización ... clientes en todo el ciclo de vida de ... una muestra de archivo, almacenamiento de documentos y ...
(Date:3/22/2017)... March 22, 2017 Ampio Pharmaceuticals, Inc. ... of Ampion™, a low molecular weight fraction of ... that it is re-issuing its previous release that was ... disclosures that are required under the NYSE MKT ... these additional disclosures along with the previously disclosed ...
(Date:3/22/2017)... -- New Jersey,s hospitals and ... saved $641 million in healthcare costs between 2012 and ... improvement program. The results reflect five ... of a national initiative from the U.S. Department of ... Hospital Association and its affiliate, the Health Research and ...
Breaking Medicine Technology: