GxP Lifeline Newsletter
MasterControl Logo
 
January | 2018
author

FDA Guidance Answers Questions Regarding Data Integrity
by David Jensen, MasterControl Staff Writer

 

An alarming increase in CGMP violations involving data integrity has come to the attention of FDA. To spotlight this issue, the regulatory watchdog has drafted a question-and-answer-based guidance, “Data Integrity and Compliance with cGMP.”

 

READ MORE

QA vs. QC, Quality Control vs. Quality Management: What’s the Difference?
by Beth Pedersen, MasterControl Staff Writer

 

In a company organized properly, quality assurance resides independent of manufacturing and operations, and quality control resides within manufacturing and operations. But what is the difference?

 

READ MORE
featured whitepaper
FEATURED WHITEPAPER
Quality 4.0: Get Educated, Get Involved, and Build a Successful Strategy
featured video
FEATURED VIDEO
Demo: MasterControl Quality Management System (QMS) Overview
featured article
SPECIAL FEATURE
FDA Inspections: Top Five Violations for FY2017
author

Future Trends and Opportunities in Quality Assurance
by David Jensen, MasterControl Staff Writer

 

It’s impossible to know exactly what future trends will influence the direction and methodologies of quality assurance (QA). However, according to Bristol Myers Squibb executive Donna Gulbrinski, looking at how quality professionals overcome current challenges can lend some insight on future QA strategies and processes.

 

READ MORE
author

20 Years Later, 21 CFR Part 11 is More Relevant than Ever
by Cindy Fazzi, Staff Writer, MasterControl

 

If 21 CFR Part 11 and the life science industry were a married couple, they would be celebrating their platinum wedding anniversary this year. For better or for worse, in sickness and in health, it has been 20 years of compliance. It’s an important milestone to celebrate and think about.

 

READ MORE
author

How to Minimize Protocol Deviations
by Laurie Meehan, Social Media Manager, Polaris Compliance Consultants, Inc.

 

If you’ve seen FDA’s Inspectional Observation Summaries, you know that in 2015 the most frequently cited violation in clinical research by far was “failure to conduct research in accordance with the investigational plan.” Do you know this also topped the list the year before that?

 

READ MORE
 

Wondering what the next five articles offer? Leadership tips, questions about ISO 13485 and 9001 and CAPA were also hot topics in 2017:

MasterControl Logo White

Corporate Headquarters 6350 South 3000 East
Salt Lake City, 84121
800.825.9117

Contact information for other regional MasterControl offices can be found at mastercontrol.com

Facebook   LinkedIn   Twitter   Pinterest  

View our other newsletters: Medical Device & Pharmaceutical

© Copyright 2000-2018 MasterControl. All rights reserved.