Featured Product
This Week in Quality Digest Live
FDA Compliance Features
Gary Shorter
Pharma needs to adapt and evolve with the changing environment of life science data
Etienne Nichols
Quality management system regulation explained
The short answer: Standard weights, rigorous procedures, and state inspectors ensure measurements are fair and accurate
Duxin Sun
One way researchers can select better drug candidates
Violetta Njunina
Five common HACCP shortages and the strategies your food establishment can use to address them

More Features

FDA Compliance News
First trial module of learning tool focuses on ISO 9001 and is available now
Free education source for global medical device community
Good quality is adding an average of 11 percent to organizations’ revenue growth
Further enhances change management capabilities
Creates adaptive system for managing product development and post-market quality for devices with software elements
VQIP allows for expedited review and importation for approved applicants that demonstrate safe supply chains
An invite from Alcon Laboratories
Intended to harmonize domestic and international requirements
Pharma quality teams will have performance-oriented objectives as well as regulatory compliance goals

More News

Quality Digest

FDA Compliance

2005 Pharma IT Compliance Week to be Held in Puerto Rico

Published: Tuesday, February 22, 2005 - 23:00

The Regulatory Compliance Workshop Group will present the 2005 Pharma IT Compliance Week training event March 7–11, in Puerto Rico. The event will feature five one-day workshops, with topics including “Auditing Computerized Systems to Pass FDA and European Regulatory Standards,” “Understanding and Applying Risk Management to Meet FDA Expectations for Computerized Systems,” “Update on the Impact of the FDA’s New Guidance for Industry on 21 CFR Part 11, Electronic Records and Electronic Signatures,” and “Designing and Implementing the Paperless Laboratory: the Regulations, the Problems, and the Practical Solutions.”

The event will be held at the Embassy Suites San Juan Hotel & Casino. For more information, visit www.rcwg.org.


About The Author

Quality Digest’s picture

Quality Digest

For 40 years Quality Digest has been the go-to source for all things quality. Our newsletter, Quality Digest, shares expert commentary and relevant industry resources to assist our readers in their quest for continuous improvement. Our website includes every column and article from the newsletter since May 2009 as well as back issues of Quality Digest magazine to August 1995. We are committed to promoting a view wherein quality is not a niche, but an integral part of every phase of manufacturing and services.