Aug 30, 2016

UDI: When the Rule is Not Enough

FDA recently issued a draft guidance 
on the form and content of the UDI.

by Jennifer D. Newberger

Hyman, Phelps & McNamara, P.C

With less than two months to go before the UDI compliance date for Class II devices, on July 26, 2016, FDA issued a draft guidance related to what would seem to be the most basic of concepts: the form and content of the UDI. More specifically, the draft guidance states that its intent is to “clarify” for industry and FDA-accredited issuing agencies the form and content of the UDI, and to “better ensure the UDIs developed under systems for the issuance of UDIs are in compliance with” the UDI rule.

Aug 25, 2016

10 Things I Wish I’d Known Before Writing my FDA Response Letter

Don't bury your head in the sand; 
start your response letter ASAP

by Alex Butler

Medical Device Segment Manager, MasterControl 

If you’ve ever received a 483 or warning letter, as I have, you know the chaos that can ensue. The clock is ticking; the FDA requires a response to most compliance notices within 15 business days!

I received a warning letter while working for a leading global manufacturer of dental materials, devices, and instruments. As part of the remediation team assigned to address the citation, which entailed overhauling the company’s entire quality system, I understand that time is of the essence when crafting a response letter and remediation plan. Working many nights and weekends, it took my team eight months to receive our close-out letter, then we spent another year implementing our remediation plan—all while performing our “regular jobs.” It was a grueling process, but I learned a few remediation lifehacks that may save you time and frustration.

Aug 23, 2016

If Taylor Swift Were Your FDA Auditor or How to Present Yourself and Your Company During an FDA Audit

Would you pass or fail if 
Taylor Swift audited your company?

by Marci Crane

Localization Manager


Note to the reader: If you’re one of the few Americans or “Planet Earthians” who has not yet heard the sweet stylings of Miss Taylor Swift blasted enthusiastically by excited millennials, then the Taylor humor in this article may not make a whole lot of sense. However, it is still worth reading. After all, you wouldn’t want to be caught off guard if an FDA auditor were to say:

“Saw you there and I thought/ Oh my God, look at that face/ You look like my next mistake.” – "Blank Space"

The current data show that an adult is likely to change employment at least a few times during his or her lifetime. Taylor Swift, on the contrary, is one of the rare individuals who most likely will never have to remake her career. However, surprises do happen, and would it be so far-fetched to imagine that at some point in the near future Taylor might take up auditing? And not just any auditing, but auditing for the FDA?

Aug 19, 2016

Mayday! Mayday! These "Unknown Unknowns" Can Torpedo Your QMS

Are knowledge gaps leading your 
quality efforts off course?

by Walt Murray, CLA, CSSMBB

ARC Experts

In psychology, people talk about knowledge and learning in terms of four levels: what we know, what we think we know, what we know we don’t know, and what we don’t know we don’t know. In the life sciences, the fourth level, what we don’t know we don’t know (or unknown unknowns, for short), carries the most risk in quality and compliance.

Aug 16, 2016

Why Russia Is an Attractive Market for Clinical Trials

Russia is an emerging 
market for clinical trials.

by Sue Lee

Technical Portfolio Manager

World Courier Management

When you think of countries as candidates for clinical trials, which ones come to mind?  North America, Great Britain, France?

What about Russia?

Aug 11, 2016

QA is Like Pro Soccer and 4 Other Things You Might Not Know About QA

QA and pro soccer have a lot in common.
Well, other than the bright lights.

by Beth Pedersen, 

Marketing Communications, MasterControl

1979 was a pretty momentous year. The Sony Walkman made its debut, Michael Jackson released his breakthrough solo album, “Off the Wall,” and Margaret Thatcher became the first woman in history to be elected as the British prime minister (more on Thatcher in a minute). But anyone who works in quality will remember 1979 for another reason altogether: the introduction of the term “quality assurance” (QA) in FDA’s 21 CFR Part 58 (1), also recognized as the first Good Laboratory Practice (GLP) regulation.

Incidentally, 1979 is also the year that Dr. Andrew Waddell, a seasoned QA pro and now director of the Scotland-based GxP consultancy TMQA, began his foray into the field. Waddell delivered the keynote presentation, titled “The Challenges Facing Today’s Quality Assurance,” at the 2016 Masters Conference, the annual event for MasterControl enterprise quality management software (EQMS) users in Europe. Drawing from his unique life experiences and 37-year tenure in QA, Waddell examined five lesser-known aspects of QA that challenge the relevance of a nearly 40-year-old regulation and point to an exciting new future of quality.

Aug 4, 2016

Leverage the Power of SOPs

by Cindy Fazzi

Editor, MasterControl Insider

Most companies establish standard operating procedures for compliance purposes, but that’s just the start and it doesn’t leverage the power of SOPs, according to Lillian Erickson, MasterControl’s global quality manager, in a recently published article in Fleet Maintenance magazine.

Erickson told the magazine that SOPs are meant to standardize processes and reduce risk. “A large company without SOPs runs the risk of having ‘too many cooks in the kitchen’ and not having critical processes performed consistently,” she said. “A small organization without SOPs runs the risk of having very little oversight, and therefore, making decisions based on best guesses.”

Aug 2, 2016

The Most Treacherous Evil Villains and the Software They Won’t Let You Buy!

by Marci Crane

Localization Manager, MasterControl

Villains, like their heroic counterparts, have interesting and complex pasts. Their complexity can be strange at times and is often hard to comprehend. After all, they generally want to kill pretty much every living creature and that can be somewhat uncomfortable for  “normal” humans to process. However, taking a look at a villain’s back story and his recurring behavior can help average human beings understand why villains are constantly trying to destroy love, joy, beauty and oh yes, that professional software you’re about to purchase.

Villains HATE Powerful Software

The utter and final truth about villains is that they hate software. Software empowers normal humans to do things faster, more effectively and without error, which makes villains seem not quite as intimidating as they would like to be perceived.

Each of the seven villains mentioned in this article hate every kind of powerful business-changing software. There may be one kind of software that each villain happens to hate the most, which is something you will see as you read this article. Take care to note the software solution(s) that you are planning to implement in your own business and which villain may come calling at your door!

Watch out!