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

What You Don’t Know You Don’t Know in Quality and Compliance Can Torpedo Your Success

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!

Jul 28, 2016

3 Areas of Focus When Responding to FDA Inspection Findings

by David R. Butcher

Marketing Communications, MasterControl

When an FDA investigator issues a Form 483 after inspecting your facility, the cited observations should be addressed in writing to the FDA within 15 days, even if the initial response will be preliminary. To prepare an appropriate response to the audit findings and get on the necessary path to mitigate and resolve the identified issues, you’ll want to focus on at least three key areas, according to ARC Experts President and CEO Walt Murray.

In the final installment of a three-part webinar series on FDA inspections, Murray, a consultant with more than 30 years of experience in quality management and regulatory affairs, recently explained how quality managers can successfully organize an internal response team, manage the corrective and preventive action (CAPA) process and ultimately provide a proper post-inspection FDA response.

Jul 26, 2016

A Warehouse Love Song

Large or small, new or old, warehouses storing 
pharmaceuticals must comply with FDA regulations.

An Ode to 21 CFR Part 

211 Subpart H

by Laurie Meehan

Social Media Manager

Polaris Compliance Consultants, Inc.

Storing stuff doesn’t sound like it should be difficult, but complying with FDA’s detailed regulations for warehousing pharmaceuticals can be.  To start, your warehouse has to be clean and pest-free.  Dirt, insects, lubricants, or other agents could compromise the packaging or prevent labels from adhering.  Your facility also needs proper drainage, ventilation, adequate space, and work lighting.  (Is your warehouse susceptible to flooding?  Do cramped or dark conditions increase the likelihood of dangerous product mix-ups?)  You also have to make sure your product is not exposed to more heat, cold, humidity, or light than stability testing recommends.  (Do you have moisture and temperature sensors throughout?  Is the heat tunnel you use for sealing shrink wrap too hot?  Do you have backup refrigeration?  Have all of these devices been cleaned, serviced, inspected, and calibrated?)  And what are your procedures if you find any safety threshold has been exceeded?  Are your people adequately trained?

Jul 21, 2016

The Proper Role of the FDA in the 21st Century

The current medical marketplace is 
very different  from the one that existed 
when FDA was founded in 1906.

by Dr. Joseph Gulfo

Executive Director, Rothman Institute of Innovation & Entrepreneurship

The current medical marketplace is vastly different from the marketplace that existed when the basic elements of Food and Drug Administration law were passed. Despite rapidly advancing technology and patients’ increasing desire to try new drugs and devices, the FDA has strayed significantly from the statutorily defined safety and effectiveness standards for drug approvals. The FDA now very often demands proof of clinical utility, including survival and disease outcomes, as a requirement for premarket approval. But hard proof of clinical utility is elusive, even for drugs that are clearly shown to be safe and effective as labeled. Rather than blocking safe and effective drugs on such grounds, we should allow physicians and patients to make outcome-oriented decisions, and rely on the medical marketplace to drive physician adoption of safe and effective drugs that prove to have great clinical utility in real-world settings.

Jul 19, 2016

Failure of Management with Executive Responsibility

FDA says that management with executive 
responsibility shall review the suitability 
and effectiveness of the quality system at 
defined intervals

By Dr. Christopher Joseph Devine

President, Devine Guidance International Inc.

Effective management teams should be fully engaged with their business operations.

For the second time in three weeks, Dr. D was able to quickly locate another rarely cited Form 483 observation: The failure of management with executive responsibility to actually review the quality management system they have been entrusted with managing. Now granted, from time-to-time it becomes a challenging task for the management representative to circle the wagons and corral all of the management-types into the executive conference room for a meeting focused on the performance of the quality management system (QMS). However, every Chief Jailable Officer (CJO) clearly understands the ramifications associated with not complying with the FDA’s sacred text, the quality system regulation (QSR). In fact, not being able to share at least documented evidence that a management review has occurred (agenda and sign-in sheet) is just not excusable. Heck, the agency even gives a ton of wiggle room with the “planned intervals” requirement, so holding at least one review annually should be a piece of cake. Right? Well, based on the performance of the device establishment targeted in this week’s guidance, the answer is a big “evidently not!” As many of the doctor’s friends and readers know, Dr. D is somewhat of a wisenheimer (look-it-up). However, when it comes entertaining the FDA during one of their friendly visits for a cup of coffee and an inspection, it is always Game On! Enjoy.

Jul 14, 2016

Your Suppliers’ Risk Is Your Risk

In today’s global marketplace, your suppliers—whether Tier 1, 2, 3 or more—are an extension of your company and your brand.

By Carrie Mantey

In today’s day and age, in which outsourcing can be the norm, and not only major global corporations stretch across the globe, but also potentially mid-market and mom-and-pop suppliers, supply chains are no longer insulated from external or environmental risk events. These risks can range from a natural disaster, such as the Japan earthquake and tsunami, to lax safety policies, in the case of the Bangladesh garment factory collapse, to the regular ebb and flow of business, including when a supplier is acquired or goes out of business. These risks are not new to the supply chain, but as the supply chain grows more complex, so do the risks to supply, especially when visibility is blurred, suppliers are far-flung and there is no backup plan in sight.