January 2013

For Quality Companies

Featured Articles

Craig Gygi

MasterControl Revs Operational Excellence Using Six Sigma

by Craig Gygi
Executive Vice President Operations, MasterControl, Inc.

The de facto standard for excellent business operations is Lean Six Sigma. Only five years ago you could not say that. But today, in every industry and every geography, companies have determined that the principles and practices of Lean and Six Sigma are the world-class standard for designing, configuring, improving, and controlling business.

In a better-late-than-never move, ISO published 13053-1/2:2011, "Quantitative methods in process improvement - Six Sigma - Part 1: DMAIC/Part 2: Tools and techniques." This further confirms Six Sigma and Lean as the standards for global operations.

Read more

Cindy Fazzi

Quality Professionals: How to Increase Your Job Security

by Cindy Fazzi
Marketing Communications Specialist, MasterControl, Inc.

The life science industry has not been immune to the global economic downturn, with pharmaceutical companies such as AstraZeneca, Roche, and AMAG Pharmaceuticals recently announcing layoffs. Similarly, medical device companies such as Stryker, Medtronic, and Smith & Nephew have announced job cuts. So, is there such a thing as job security anymore?

Paula Rutledge, president and founder of Legacy MEDSearch, a recruitment firm exclusively serving the medical device and healthcare industry, noted the overall unemployment rate in the United States (7.9 percent in November 2012 versus 8.9 percent the previous year) and was generally upbeat about the job picture.

Read more

Laurie MeehanRosanne Sylvia-Heeter

What SOPs Do You Need As A Dietary Supplement Distributor?

by Laurie Meehan and Rosanne Sylvia-Heeter
Internal Project Manager and Director of Good Manufacturing Practice Compliance, Polaris Compliance Consultants

If you look at the cGMP regulations for dietary supplements, you'll notice that only one subpart includes the words "holding" or "distributing" in its title. With only 10 or so individual requirements, the aptly-named Subpart M, "Holding and Distributing," is shorter than most. If you're thinking this means there's a much lighter regulatory burden placed on companies that simply hold or distribute dietary supplements than on companies that manufacture them, you'd be right. At the same time, you'd be incorrect to assume that regulations for holding and distributing dietary supplements are restricted to this single subpart. At least eight of the 16 subparts that comprise 21 CFR Part 111 are applicable to holders and distributors and all the activities outlined in these subparts require SOPs.

Subpart B, "Personnel" requires that your employees be qualified for the positions they hold and be trained in hygienic practices and warehouse operations. Naturally, this training needs to be documented. SOPs are needed to describe the procedures you have in place to comply with these staffing requirements. That's important, because as you read on, you'll see the warehouse staff has a lot of responsibilities.

Read more

Featured White Paper:

Top Five Ways Automation Can Boost Financial Success in the Life Sciences Industries

View Upcoming Events

Previous Newsletters

Editorial Staff
About MasterControl

Follow us on Facebook, LinkedIn and Twitter