Document management is such a fundamental need in any FDA compliance effort, and it poses so many challenges, that we could easily discuss the ?top 20? or more problems that plague life science companies. But in the interest of space, here are the top five document control issues that most companies complain about and some tips on solving them.
In June 2007, the U.S. Federal Drug Administration issued the Dietary Supplement Current Good Manufacturing Practice (CGMP) Final Rule (21 CFR Part 111). In essence, the final rule requires that the proper controls be in place for dietary supplements during manufacturing, packaging, labeling, and holding operations.
The medical device and pharmaceutical industries are built upon process orientation to complete tasks in a uniform and documented fashion. Both industries also depend upon a systematic series of linked and reproducible activities completed by trained people to enable inputs to become outputs and outputs to realize a return on investment.So, how does process mapping help these industries in turning inputs into predictable outputs that would help them comply with regulations, as well as realize co
Training employees to perform tasks in a laboratory or technical environment is critical to the success of any regulated business. Assessing employee skill levels is one way to see if employees are comprehending what they are learning.
April 13, 2017
By David Hofstetter, Manager, Learning and Development, New England Organ Bank
Keeping up with the changes and the training in tissue and organ banking is an ongoing process. We know what works well and what doesn't. We know with a field-based staff that classroom training is difficult to pull off when trying to coordinate everyone's schedules and of course working around the case load. What we have found is that online learning or on-demand learning does work. This allows all of the staff to access training when and where they need it. We currently offer the following typ
April 4, 2017
By Paul Sanderson, Solutions Consultants Manager, MasterControl
“Quality management” is one of those terms that sounds so simple and esoteric at the same time, like DNA or free cash flow. I’m pretty sure I know what those terms mean until I start explaining them to someone.
March 27, 2017
By Beth Pedersen, Staff Writer, MasterControl
We all have those days where everything that can go wrong, does. Where it seems the entire universe is working against you, testing your patience, your determination and your will to carry on. But in the scheme of things, are these so-called bad days really
March 21, 2017
By Christine Park, Founder and Consultant, Christine Park & Associates
Most organizations are well under way with the transition to the new ISO 9001:2015. As such you should be very familiar with the emphasis on two four-letter words found throughout the document ….
March 1, 2017
By Erika Miller, Food Safety Specialist, D.L. Newslow & Associates, Inc.
As a food safety and regulatory consultant, I work with diverse clients who face many different challenges with Food Safety Modernization Act (FSMA) implementation. The ones that are the hardest to address fall into the intersection between company policy and regulatory requirements. Supply-chain approval is a major challenge for many larger corporate clients, as well as smaller clients who must remain flexible to maintain profitability. The requirements of the Foreign Supplier Verification Prog
February 7, 2017
By Mike Orzen, Founder, Mike Orzen & Associates
“Over time I’ve come to realize that engaging in this problem-solving process is actually the highest form of respect….The manager truly respects the employee’s knowledge and his or her dedication to finding the best answer….Only by showing mutual respect-- each for the other and for each other’s role-- is it possible to solve problems, make work more satisfying, and move organizational performance to an ever-higher level.”
January 19, 2017
By Christine Park, Founder and Consultant, Christine Park & Associates
I have long been a supporter of being well prepared for FDA inspections, including how data is presented during the inspection. Historically, you’d print the files for FDA review rather than do a live demonstration of the database information. While I haven’t experienced it yet, it is my understanding that the FDA is now requesting a “live” data review. Essentially the expectation is for you to walk the inspector through your files and explain the information rather than have you print and organize paper files before they see it.
November 29, 2016
By Patricia Santos-Serrao, Director of Product Strategy, MasterControl
In a classic episode of Seinfeld, George Costanza is terrified of the potential ramifications of his “worlds colliding” when his fiancée, Susan, becomes friendlier with his dubious pals Elaine, Kramer and Jerry. “Everybody knows you’ve got to keep your worlds apart,” George rants (but when does George not rant?) “If Susan is allowed to infiltrate this world then George Costanza as you know him ceases to exist. If Relationship George walks through this door, he will kill Independent George! A George divided against itself cannot stand!”
November 8, 2016
By Kimberlee Washburn, Regulatory Compliance Associates
It is unfortunate that so many new medical devices and new generation product launches are delayed due to the absence of regulatory input at the beginning stages of design control and the new product development process.
November 2, 2016
By Vivian Bringslimark, President and Owner, HPIS Consulting, Inc.
Ask an operations manager and he’ll acknowledge that what it’s called is less important than getting the “assignment” done and entered into the LMS. He’s usually more concerned about the loss of productivity during the training than the effectiveness of the training at that time. It isn’t until later when the training may have to be delivered again (repeated), that the comment “training doesn’t really work” is heard.
