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 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.

Apr 14, 2016

CFDA Medical Device Software Regulation Undergoes Major Revision

As more and more medical devices 
rely on software to function, regulatory
 requirements for software become 
increasingly demanding.

by Beth Pedersen

Marketing Communications


With so many international regulatory bodies governing different countries and industries, it can be difficult for manufacturers to stay abreast of all of the changing regulatory environments and requirements across the globe. On August 5, 2015, China Food and Drug Administration (CFDA) released its “Principle of technical review of medical device software” (2015 Order No. 50). The principle, which is only available in Chinese, signals a major change for documentation requirements for stand-alone software or software components developed by medical device manufacturers or their development partners.

Apr 12, 2016

Med Device: How to Address the Documentation Burden of Design Control

by Matthew M. Lowe

Executive Vice President


This is an excerpt from an article published in the March 2016 issue of Medical Design Briefs.

Design control issues represent a key challenge for many medical device firms. This is the reason why in 1996, the U.S. Food and Drug Administration (FDA) added design control principles to 21 CFR Part 820 and required rigorous documentation to demonstrate design control.

The revision required manufacturers of some Class I and all Class II and Class III devices to follow the conditions and parameters provided under Subpart C, Section 30 of 21 CFR Part 820, also known as the Quality System Regulation (1). The mandate added a whole new level of complexity to the already rigorous and challenging device development process. In addition to designing and testing devices, development engineers must also ensure that all necessary documentation pertaining to design control is in place. This amounts to hundreds if not thousands of documents for every single product launch.

Apr 7, 2016

Can’t-Miss Tips for Exposing Risk during Medical Device Development

The road to product success 
begins and ends with risk. 

 by Lisa Weeks, MasterControl  Communications

Do you confuse risk analysis with risk     assessment? Do you struggle to distinguish between a hazard and harm? Does the term risk management strike fear into your heart? If so, you’re not alone. Despite the publication of ISO 14971 in 2000 and, more recently, the inclusion of risk-based thinking among ISO 9001:2015 and ISO 13485:2016 requirements, many device manufacturers still struggle to understand, identify, assess and track risk across the product development lifecycle.

Apr 5, 2016

Income Tax Myths and Document Control Systems

This is the United States Treasury, seat of our nation's  
accounting, revenue collection, money production, 
and economic policy formulation.

by Robyn Barnes

Marketing Communications


Sometimes myths remind us how technology can change the course of history.

I’ve been reading Steve Berry’s novel, “The Patriot Threat.” The crux of the book is that the 16th Amendment to the Constitution, the one that requires Americans to pay income tax, may be illegal. The story goes that some of the states may have never ratified the Amendment, and some may have ratified a document that didn’t have the same wording as others. (I won’t spoil the mystery by telling you what transpires.) 

Apr 4, 2016

Compliance, Innovation and GMPs at the 32nd SQA Annual Meeting & Quality College

MasterControl's Ken Peterson and 
Michael Alfano will address attendees at the 
32nd SQA Annual Meeting & Quality College.

by Robyn Barnes

Marketing Communications


If you’re not cultivating a culture of quality at your workplace, what are you doing to improve compliance, innovation and good manufacturing practices (GMPs)?

Ken Peterson and Michael Alfano of MasterControl will be addressing these questions at the 32nd SQA Annual Meeting & Quality College, to be held April 3-8 at the Gaylord Texan Resort & Convention Center in Grapevine, Texas.