GxP Lifeline Pharmaceutical Publication Click to visit GxP Lifeline Home Click to visit mastercontrol.com

Featured Articles

June 2010

Marla A. Phillips

Six New FDA Enforcement Policies: How They Impact You

Marla A. Phillips
Director, Med-XU, Xavier University

On August 6, 2009, FDA Commissioner Dr. Margaret Hamburg publicly announced the FDA's new enforcement strategy. This strategy involves six new policies that went into effect on September 15, 2009. What are the policies and what do they mean to you? The best line of defense is to have excellent quality oversight now to ensure that the systems in place are compliant, functional, and effective. Then your firm won't have to worry about getting a warning letter in the first place. Easier said than done...but more critical now than ever.

Read more


Seth Mailhot

Tips for Avoiding Internal and External Supplier Problems

Seth Mailhot
Lead, FDA Practice, Nixon Peabody LLP

The signing of the historic healthcare reform legislation will have a significant impact on both the medical device and pharmaceutical industries. A significant increase in the number of individuals carrying health insurance will translate into a greater demand for medical devices and pharmaceuticals. While this will improve profitability for many companies, it will present challenges to manufacturing and quality managers tasked with finding ways to quickly increase production.

Read more


Jason Clegg

Quality Audit: A Tool for Continuous Improvement

Jason Clegg
Marketing Director, MasterControl, Inc.

The word "audit," in the broadest sense, refers to a variety of activities. It may refer to an accounting firm examining the financial statements of a public corporation, or a consultant checking the process of lid sealant dispensing in a semiconductor package assembly line. It may even refer to a mystery shopper testing the patience of sales clerks in an upscale department store.

In this article, we'll systematically take a closer look at some things (e.g, financial statements, a factory process or even customer service) and discuss the results for purposes of evaluation and—ultimately—decision making.

Read more


 

Featured Webinar:

Featured White Paper:

Previous Newsletters:

Watch Customer Videos

View Upcoming Events

Did You Know?

MasterControl CAPA Workshop & Regulatory Session
August 4-5, 2010, Tokyo, Japan

MasterControl CAPA Workshop & Regulatory Session
September 15-16, 2010, Newport Beach, CA

MasterControl CAPA Workshop & Regulatory Session
October 27-28, 2010, San Francisco, CA

BARQA Annual Conference
November 2-5, 2010, Leeds, UK

View More Events

Did you know that an efficient, collaborative document review process can reduce document review cycles and therefore project timelines by up to 65 percent? Studies undertaken by PleaseTech's PleaseReview™ customers show that using collaborative document review can reduce document review cycles by as much as 65 percent. Multiplied over a single project that is quite the savings!
Read More