May 24, 2016

Accelerate Time-to-Market by Improving Process Validation

In the eyes of the FDA and other regulatory 
bodies, inadequate documentation is unacceptable.

by James Jardine, Marketing Communications, MasterControl

Process validation, a general term for critical disciplines such as risk mitigation/management, quality assurance and change management, is something that far too many life science manufacturers only worry about when a product is just about to go to market. That late in the game, though, it can be hard to produce the required and relevant information that has accumulated during years of product development. In a recent article in PharmTech titled “Reducing the Documentation Burden in Process Validation,” Patricia Santos-Serrao, RAC, of MasterControl explains how regulatory agencies define process validation as it pertains to the collection and evaluation of data from the process design stage all the way through to commercial production. 

May 19, 2016

SOP Revision SWAT-Style

You can SWAT your SOPs using 
the procedure outlined below.

by Laurie Meehan

Social Media Manager

Polaris Compliance Consultants, Inc.

SOP revision. It falls somewhere between income tax prep and colonoscopy prep on the likability scale.  So why would you want to read about it?  Maybe you’re hoping someone’s figured out a way to make the process more efficient and less painful.  Maybe we have.

The SWAT Technique

Last month, we worked with a company to revise a set of SOPs (standard operating procedures) using a technique we call SWAT.  (Any edgy appeal that name might have otherwise had will be immediately dulled by its acronym expansion: “SOP Working Analysis Team.”  It’s the best we could do.  Don’t judge.)

The goal of the SWAT technique is to revise the most documents in the least time, while preserving friendships, sobriety, and original hair color.  The heart of SWAT is an immersive, multi-day working session in which participants discuss SOP revisions and incorporate them in real time.  Careful planning, thorough preparation, and commitment from management and participants are keys to keeping the SWAT session productive.

May 17, 2016

Five Reasons Why TMF Training is Important

Providing employees with the proper training 
takes time but pays off when it's time to
prove your TMF is inspection ready.

by Sholeh Ehdaivand

President and CEO

LMK Clinical Research Consulting

Training is a vital component of workplace efficiency especially when it comes to one of the most important deliverables of a clinical trial – the Trial Master File (TMF). Perhaps that’s why, according to a recent article in Forbes magazine, U.S. companies spent over $70 billion on corporate training in 2014, an increase of 15% over the previous year.  If you are lucky enough to oversee the TMF, you spend so much time bringing the right employees on board, it only makes sense you would understand the importance of providing them with the proper training to ensure your TMF is always inspection ready. 

May 12, 2016

The FDA Just Completed Its Inspection...Now What?

by David R. Butcher

Marketing Communications, MasterControl

Even after an FDA investigator has completed an inspection at your facility, there’s still plenty of work that remains. At the conclusion of an audit, the inspector will hold an exit interview to discuss observations and present significant findings on a Form 483. What do you do next?

In the second installment of an ongoing webinar series on FDA inspections, ARC Experts President and CEO Walt Murray, a consultant with more than 30 years of experience in quality management and regulatory affairs, recently offered some ideas about what steps to take after an FDA investigator has finished an inspection, issued a 483 and left your facility.

May 10, 2016

Need Help Navigating UDI? FDA Can Help

Free UDI training is available 
on FDA's website

Compiled from MedTech Intelligence
and FDA reports

Although the unique device identification (UDI) rule was finalized in September 2013, the compliance rollout period will last several years (based on device classification).  To help companies as the rule is phased in, FDA has posted five new education modules.  You can find these on the CDRH Learn site.

More UDI information is available in a previous GxP Lifeline blog post.  

May 5, 2016

Cleanroom Compliance: How to Address Common Challenges in Document Control

by Dave Hunter

Product Management Director 



This is an excerpt from an article published in the March 2016 issue of Controlled Environments.

A recent warning letter to a medical device firm shows the importance of proper documentation of cleanroom maintenance procedures and corresponding control of those documents. The FDA noted the company’s failure to establish and maintain written procedures for avoiding contamination of equipment, as well as the incongruity between some of its cleanroom procedures and records of actual practice (1).

For companies regulated by the U.S. Food and Drug Administration (FDA), requirements pertaining to cleanroom and controlled environment procedures can be found in predicate rules such as 21 CFR Part 211 for pharmaceutical companies and 21 CFR Part 820 for medical device manufacturers (2).

May 3, 2016

Top 10 Medical Device Inventions Critical to Parenting

The forehead thermometer is on 
the author's list as a top 10 medical 
device invention for parents.

by Robyn Barnes

Marketing Communications


I’m a medical device article junkie and I love all those “Top 10” lists that everyone publishes.  Recently I saw one entitled “Top 50 Medical Device Inventors of All Time.” Nice article but it had a few flaws.  First, most of the inventors were men.  Who doesn’t know that necessity is the mother of invention?
In that same vein, as I perused the list, I noticed that not one of the inventions is something I’d ever use at home on my son.  While I certainly appreciate the importance of the full-body MRI, I don’t keep one around the house.

So I’ve compiled my own “Top 10 Medical Device Inventions” critical to parenting, in no particular order.  See how many of these you use on a weekly basis:

Apr 28, 2016

Proposed Legislation Would Create a New Conditional Approval Pathway to Market for Regenerative Medicine Products

Human cells, tissue or cellular and 
tissue-based  products are known as HCT/Ps.

by Jeffrey K. Shapiro & 

Charlene Cho Hyman

Phelps & McNamara, P.C.

In the emerging world of regenerative medicine, there is a stark dichotomy in the level of regulation applied to products derived from human cells and tissues, or what FDA calls “human cells, tissue or cellular and tissue‑based products” (HCT/Ps).

If an HCT/P meets certain requirements, it is eligible for regulation solely under section 361 of the Public Health Service (PHS) Act. A “361 HCT/P” does not undergo any premarket review by FDA prior to marketing.   Once marketed, under 21 C.F.R. Part 1271, such products must comply with donor screening and eligibility requirements, as well as labeling, adverse event/manufacturing deviation reporting to FDA and product handling (Good Tissue Practice) requirements.

Apr 26, 2016

Don’t Trip over These 9 Document Control Pitfalls

Most organizations that use a paper-based 
or a partially electronic system stumble 
over these nine common document control issues.

by Dave Hunter 

Product Management Director


Document control issues are among the most commonly cited observations in FDA Form 483s and warning letters. In the medical device sector alone, document control-related issues represented 10 percent of Form 483 observations and 8 percent of warning letters in 2014(1).

Document control refers to procedures for approval, distribution, and change of a document and the designation of a person or people to implement those procedures. It is a basic requirement fulfilled by one person in some companies and a full-scale department in others. While companies vary, for most of them, document control spans the following stages: 

Apr 21, 2016

4 Downton Abbey Characters Who’d Make Great Quality Professionals (and 4 Who’d Be Bloody Awful)

Is there a Lady Mary sitting in the cubicle next to you?   

by Lisa Weeks, Marketing Communications, MasterControl 

Are you experiencing Downton withdrawal now that the award-winning PBS costume drama is officially over? You’re not alone. Monday morning water cooler banter hasn’t been the same since our friends in the Great House threw the dust shields over the furniture and bid us farewell. If you’re missing your favorite Downton characters, don’t fret. There is probably a Mr. Carson or Lady Mary sitting in the cubicle next to you. After all, several of members of the Crawley household, upstairs and down, possess the skills and personality traits needed for a successful career in quality management—others clearly don’t. Warning: Spoilers ahead!

Apr 19, 2016

Coming Soon to a Pharma Inspection Near You: The Program Alignment Group (PAG) Plan

by Mark Schwartz Of Counsel,  Hyman, Phelps & McNamara P.C.

There have been at least four FDA initiatives, in the works for some time that, in the coming years, will change the way pharmaceutical (and indeed all FDA) inspections are conducted. We think you should know about these initiatives, and how they are likely to affect the way companies prepare for, and deal with, FDA inspections. Today, we are going to discuss the Program Alignment Group (PAG) plan, arguably the least controversial of the four. Over the next few weeks we will discuss the other three programs that are likely to dramatically affect the inspection landscape.

Apr 18, 2016

The Importance of Applying Risk-based Design Control to Process Validation

Design transfer continues to be a 
major cause of quality problems.  
Walt Murray will address this regulatory 
development at INTERPHEX.

by Lisa Weeks, MasterControl Communications

In order to have a successful submission for approval of drugs, medical device, biotechnology, supplements, combination product and IVD an organization must have a prolific and structured design process. According to regulators, this process must now include the explicit condition of technical transfer as a formal review step to manufacturing/assembly.