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.

Jul 13, 2016

Aligning ISO 13485:2016 With Additional Standards and Regulations

The 2016 MedTech Intelligence Conference 
will provide a wealth of ISO information 
and CEU credit, too.

by Marci Crane

Localization Manager


MedTech Intelligence, a content hub for the medical device industry, provides a continuous stream of new business analysis, technological news, trend summaries, regulations, expert opinions and networking opportunities to medical device professionals. MedTech Intelligence will host the upcoming 13485:2016 conference on July 28-29, 2016 at Dentons, 1900 K Street NW, Washington D.C.

Jul 12, 2016

What Will Quality Look Like in 20 Years?

What is the future of quality if 
young professionals don't enter the field?

by Peter J. Holtmann

President and CEO 

Exemplar Global

To look to the future, the quality profession is revisiting its roots. The question is, “Where is the next generation to help the profession look ahead?” Or, as I like to think of it, “What’s the emoticon for quality?”

I recently attended ASQ’s World Conference on Quality and Improvement where we discussed powerful questions such as, “What will quality look like in 20 years? What will it be called? Will it still be relevant?”

Jul 7, 2016

From Spectacular to Sensible: How Cost Control is Driving Innovation in the Medical Device Industry

Value-based reimbursement requires 
a new innovation paradigm.

by Mickey Garcia 

Segment Manager, Medical Devices, MasterControl  

In the old world, small incremental improvements to medical products could mean big profits if you could get them to market first. In other words, the business drivers in the medical device industry typically included evolutionary innovations in product performance and speed to market. Cost savings rarely, if ever, came into play. However, in today’s brave new health care world, payers are increasingly scrutinizing the precise gains in the outcomes from an improved product. 

Jul 5, 2016

Clinical Trial Recruitment Planning: FDA and Others Provide Tips and Tools

Recruitment plans should start early 
in the trial planning stage, involve 
all stakeholders, and continue throughout 
the life of the trial.

by Mukesh Kumar

Adjunct Assistant Professor, Clinical Research and Leadership at George Washington University

Challenges in recruiting patients are the most common reason for delays and increasing costs of clinical trials. This week (1) the Clinical Trial Transformation Initiative (CTTI), a joint program between FDA, Duke University and industry representatives, announced recommendations for creating robust recruitment plans for clinical trials taking into consideration the most common challenges and potential solutions. CTTI also released a set of four tools to help with the recruitment planning. These recommendations are based on a survey of the most common reasons trials fail to recruit adequate number of participants and suggest actionable solutions.