Q&A with Bill McLain on Internal Audits

Q&A with Bill McLain on Internal Audits

Mark Crawford

Bill McLain is an American Society on Quality (www.asq.org) expert on auditing. He is a member of Regulatory Affairs Professional Society (RAPS) and ASQ’s Biomedical Division. McLain has earned the Regulatory Affairs Certification and holds a Bachelor of Science degree in mechanical engineering from Grove City College.

Q: What is the purpose of doing internal audits? Keeping the FDA from knocking on the door? Keeping clients and end users safe? Saving on operational costs? Being competitive?

There are two main reasons for conducting internal audits. A mature organization will conduct audits because it truly believes in the “plan-do-check-act” cycle. Those organizations realize that internal auditing is one of the best tools available to check what has been implemented. These organizations may be further along in their auditing experience to entrust the auditors with auditing for business improvement, efficiency, and overall effectiveness. (more…)

FDA and CMS Team up to Review Innovative Medical Devices

FDA and CMS Team up to Review Innovative Medical Devices

On October 7 the FDA and the Centers for Medicare & Medicaid Services (CMS) on announced a “parallel review” pilot program for reviewing medical devices for FDA approval and Medicare coverage.

Both organizations have agreed on guiding principles that are designed to streamline the processes and reduce the time span between marketing approval or clearance decisions and national coverage/payment determinations.

“By reducing the interval between FDA marketing approval and Medical coverage, this process will facilitate the development of innovative products and shorten the time it takes to bring these important products to patients,” states the FDA. (more…)

Are You Ready for the EU’s New e-Labeling Rules?

Are You Ready for the EU’s New e-Labeling Rules?

Mark Crawford

In June 2011 the European Commission released a draft regulation on e-labeling (http://ec.europa.eu/enterprise/tbt/). The comment period is over and the final version is expected to be adopted on December 14, with activation starting in March 2013. This gives medical device companies about a year to catch up on the details—of which there are many. (more…)

Will the Medical Device Regulatory Improvement Act Be a Game-Changer?

Mark Crawford

Three years ago the FDA enacted tougher measures to reduce the potential conflicts of interest for medical device experts advising the U.S. Food and Drug Administration (FDA).

Claiming that these rules are strangling the timely advance of new medical devices to the market, U.S. Senators Amy Klobuchar (D-Minnesota), Richard Burr (R-North Carolina), and Michael Bennet (D-Colorado) have introduced the “Medical Device Regulatory Improvement Act” in an effort to streamline the FDA regulatory process.

Their hope is to reverse the 2007 law that bans experts with financial ties to companies from serving on advisory panels without a waiver. Currently individuals are barred if they have potentially conflicting financial interests exceeding $50,000. (more…)

Beware: Annex 11 Has Implications for Medical Devices

Beware: Annex 11 Has Implications for Medical Devices

Mark Crawford

In January 2011 the European Medicine Evaluation Agency (EMEA) released an updated version of the European Union’s GMP Annex 11 for computerized systems (Annex 11), as well as an expanded version of Chapter 4 on document management.

These are significant changes for the pharmaceutical industry—the new Annex 11, for example, is about four times larger than the older version

EMEA decided to overhaul Annex 11 to keep up with the increased use of computerized systems in all aspects of good manufacturing practice (GMP), as well as their increased complexity. Annex 11 now addresses the regulatory needs of modern IT systems and imparts extensive requirements for compliance at all levels—for example, it dictates how computer printouts of critical records must indicate if any data has been changed since the original entry. Other key topic areas include business continuity, incident management, electronic signatures, migrating and archiving documents, and more comprehensive security controls. (more…)

Root Cause Analysis and Human Factors

Root Cause Analysis and Human Factors

Mark Crawford

In its new white paper, “How to Reduce Human Error by Managing Human Factors,” the FDA indicates the “typical response to a human error is retraining. But studies have now shown that training —or lack thereof—is responsible for only about 10 percent of the human errors that occur. Despite [an increased] awareness of human errors, companies still frequently fail to substantively and correctly address errors.”

Companies often turn to training, or retraining, as a quick and easy solution for a human error, when the real cause may be a deeper, systemic issue that could be revealed through root cause analysis (RCA). (more…)

Could Your Quality Systems Protect You in a Court of Law?

Could Your Quality Systems Protect You in a Court of Law?

Mark Crawford

Quality system management and documentation contain a wealth of information (or lack of) that can be used by a regulatory agency like the FDA or a plaintiff in a lawsuit to determine if the company is in compliance with federal regulations or its own internal quality management procedures. Failure to meet these requirements can be highly damaging to a company in litigation.

“Quality manuals and quality system documents are intended to guide the operation of a company’s quality management system, says James Kolka, president of Kolka & Associates in Atlanta and an international legal consultant in regulatory affairs. “Quality system documents are neither intended nor constructed to provide evidence of a company’s concern for patient safety and product safety. If a company wants to prove it cares about patient safety and make safe products, it must build documentation to prove that point.” (more…)

New Guidance on Postmarket Surveillance from the FDA

New Guidance on Postmarket Surveillance from the FDA

Mark Crawford

The FDA continues to roll out new guidance documents for medical device regulations—this time presenting updated rules for postmarket surveillance.
The draft entitled “Postmarket Surveillance under Section 522 of the Federal Food, Drug and Cosmetic Act,” released by the FDA on August 16, provides a summary of the revised postmarket surveillance program, including new modifications. (more…)

Lean Is the Cornerstone of Quality

Lean Is the Cornerstone of Quality

Mark Crawford

Eliminating waste in a process is essential for reducing complexity, lowering risk, increase productivity, improving quality, and reducing overall costs—savings that can be passed on to the client through lower pricing. A simpler, more streamlined process also makes reproducibility and validation easier.

There are lots of ways to tackle quality improvement, including monitoring equipment and software. But one of the easiest and least-expensive ways to improve quality and reduce risk is value stream mapping (VSM), one of the key principles of lean manufacturing. In fact, VSM is so simple it just requires a pencil and a piece of paper. (more…)

Take the Lead when It Comes to Compliance

Take the Lead when It Comes to Compliance

Mark Crawford

Even though it’s easy to complain about regulatory agencies, without them things tend to get worse, not better (the financial industry, for example). There will always be companies that, when regulatory agencies aren’t looking over their shoulders, are tempted to slack off a bit, especially when the economy is tough, money is tight, and there are plenty of fires to put out.

So resist the temptation to slide (it’s always rough at the bottom). Be your own regulatory cop, whether you are being watched or not. Invest in whatever is necessary to fully understand compliance regulations, meet them, and even exceed them—for the simple reason that it is the best thing to do to protect yourself and your customers. (more…)