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:4/25/2017)... , ... April 25, 2017 , ... ... solutions, announces the continuation of its strategic partnership with and platinum sponsorship of ... nations in the safe and effective management of complex spine deformity cases, particularly ...
(Date:4/24/2017)... ... ... The Santana Telehealth Project was honored with the 2017 ATA Humanitarian Award. The ... conference, on April 23 in Orlando, FL. , “I am proud that ATA is ... poor and underserved in other parts of the world,” said Jonathan Linkous, CEO of ...
(Date:4/24/2017)... ... April 24, 2017 , ... The bar for just about everything—apparel, ... inhabiting the rarified air of pop and film stardom.(1) Not to be left out ... the smile. Grins now run the gamut from being encrusted with jewels and precious ...
(Date:4/24/2017)... ... ... Veteran Theresa James awoke to the sound of her newly ex-husband breaking ... James depicts every parent’s worst nightmare, when her three children were violently taken from ... throughout my divorce,” James said. “After the death of my children, I continued to ...
(Date:4/24/2017)... ... April 24, 2017 , ... My T Chai, a South African company that ... for purchase on RevNutrition.com, a popular website specializing in sales of nutritional products. ... ancient India and Siam. It spread across Asia and Africa quickly, and today recipes ...
Breaking Medicine News(10 mins):
(Date:4/19/2017)... 2017 Global Surgical Drainage Device Market: Overview ... to remove excess liquid and air. The fluid to ... or lymph. Surgical drains are used in a wide ... surgery, cardiovascular surgery, neurosurgery, plastic surgery etc. Common use ... accumulation of fluid e.g. blood or pus. Surgical drains ...
(Date:4/19/2017)... Companion animal vaccines ... pets such as canine, avian and feline. ... such as Attenuated Live Vaccines, Conjugate Vaccines, Inactivated ... Recombinant Vaccines. Attenuated live vaccines are derived from ... have been weakend under laboratory conditions. Conjugate vaccines ...
(Date:4/18/2017)... 2017 Cogentix Medical, Inc. (NASDAQ: CGNT), a ... Uro/Gyn and Gynecology markets with innovative and proprietary products, ... March 31, 2017 after the market close on Tuesday, ... host a conference call and webcast to discuss its ... 2017 at 4:30 p.m. Eastern Time (3:30 p.m. Central ...
Breaking Medicine Technology: