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:5/24/2017)... (PRWEB) , ... May 24, 2017 , ... ... practice is offering holistic pediatric dentistry options for its patients on Long Island, ... the patient’s entire physical well being, and is one of the biggest trends ...
(Date:5/24/2017)... ... 24, 2017 , ... Technique, technique, technique – with a dash of common ... strength training and exercise or simply lifting heavy objects, advises Dr. Kaliq Chang, interventional ... Dr. Chang says. “Improper technique in lifting anything heavy or an attempt to lift ...
(Date:5/23/2017)... ... May 23, 2017 , ... Allegheny Health Network and the ... Center for Women’s Behavioral Health at West Penn Hospital , a unique facility ... suffering from pregnancy-related depression. Construction of the Center is underway with a scheduled ...
(Date:5/23/2017)... California (PRWEB) , ... May 23, 2017 , ... ... management (PHM) technology and a 2017 Best in KLAS category winner, has named ... market position to extend and enhance its technology platform and product offerings,” says ...
(Date:5/23/2017)... ... May 23, 2017 , ... By all indications, and due ... County. While officials call for diligence, asking homeowners to scout for any open water ... concerns. Along with the annoying buzz of mosquitos is the buzz associated with potential ...
Breaking Medicine News(10 mins):
(Date:5/10/2017)... , May 10, 2017 Global Health Intelligence ... Latin America , published its 2017 ranking of ... is based on extensive data analysis from GHI,s hospitals ... hospitals database for the region. The GHI database covers 86% ... offering more than 130 data points for each institution in ...
(Date:5/9/2017)... , May 9, 2017  Demonstrating its ... board of directors for the Pharmaceutical Research and ... for membership. Biopharmaceutical companies will now have to ... order to be eligible to join PhRMA. ... the board is sending a clear message that ...
(Date:5/6/2017)... 2017   Provista , a proven leader in the ... today announced Jim Cunniff as the company,s new ... business experience to Provista, including most recently serving as the ... California . He assumed his new role with Provista ... fit for Provista," says Jody Hatcher , president, Sourcing ...
Breaking Medicine Technology: