KEC Consulting

KEC Consulting specializes in conducting on-site, practical FDA/QSR training programs and realistic, simulated FDA-style audits.

Training programs and audits are performed by company president Kenneth E. Carrier who draws on his prior experience as an FDA investigator and medical device industry regulatory professional.

Using Ken’s program has yielded dramatic improvements in compliance. I highly recommend Ken’s training programs, simulated FDA-style audits and employee coaching, and consulting services.

Howard Miller, President
Teleflex Arrow Cardiac Care

Without question Ken Carrier is the number one person we would go to for our independent audit and training needs.

John Coolidge
Sr Vice President Operations
iWalk, Inc. (BiOM Personal Bionics)

Bio

Ken Carrier began his regulatory career as an Investigator with the U.S. Food and Drug Administration for a seven year period from 1977 to 1984.

It was during this period that the medical device industry was first acclimating to the medical device Good Manufacturing Practices (GMP) regulation.

In 1984, Ken joined the regulatory team at Dyonics Inc. (now part of Smith and Nephew), a manufacturer of powered arthroscopic surgical equipment, and managed that department through late 1988, a period of explosive growth in arthroscopic surgical equipment sales.

Ken then joined Neoligaments LTD. (now Xiros), an English orthopedic company, as manager of North American Operations. This position involved managing all U.S. clinical trials, regulatory submissions and business activities.

In 1991, Ken established KEC Consulting, a regulatory consulting company specializing in conducting FDA/QSR training programs, performing simulated FDA audits to help firms prepare for an actual FDA inspection, and assisting medical device companies with regulatory compliance issues. During this period, Ken has successfully assisted many large and small companies.

Ken worked as an investigator for the FDA in the Boston district office and performed inspections within the various industries regulated by FDA with an emphasis in the medical device area.

Ken is a member of the Regulatory Affairs Professional Society and the ASQ, and has served as a speaker on GMP and Quality System Regulation issues at medical device seminars. Ken is also the Founder/President of Shared Sciences, a company dedicated to bringing exciting, hands-on science education programs into schools.

Course Outline

THE QUALITY SYSTEM REGULATION AND THE FDA

How Do They Affect Your Job?

Kenneth E. Carrier of KEC Consulting (a former FDA Investigator himself) announces the availability of the following in-house medical device training program which is designed to increase awareness and understanding of both the FDA and the Quality System Regulation (QSR) for employees at all levels of your organization.

Course Outline (Four-Hour Course)

Section 1; The FDA

A brief review of the origins, background, authority, and focus of the FDA and the basis of the law they enforce relative to medical devices
An understanding of the primary enforcement terms; adulteration and misbranding
How your procedures and records are assessed for compliance to the law
When and what to expect during an FDA inspection

Section 2; The Quality System Regulation

An example-based section by section review of the intent and meaning of the QSR with a focus on frequent errors and deficiencies which often result in significant non-conformities. I use specific examples from many of my prior audits of companies, as well as, examples pertinent to your own organization, if available.
Steps individuals can take to “self-diagnose” potential deficiencies within their areas of work and the importance of striving for compliance

Section 3; The Inspection

Preparing for and managing FDA inspections
What FDA investigators are looking for
The “do’s and don’ts” of interacting with FDA investigators

Section 4; After the Inspection / Summary

Discuss FDA’s current position relative to enforcement using experience based situations, example 483s, Warning Letters, etc.
A brief interactive exercise is used to reinforce the concept that quality must be designed and built into a product; it cannot simply be inspected in as the final step of a process.
Summary / Wrap up / Gold Standards for inspections
Questions and Answers

This course is designed as a four hour program and the course certificates provide documentation of FDA/QSR training. There is also 6 hour version which includes internal auditing techniques for QSR elements.

Services

No employee comes to work saying, “I can’t wait to screw up the company’s quality system compliance today!"

Generally, employees want to do a good job and to do tasks correctly. Yet we often hear from the FDA of medical device companies which were found to have systematic/major quality system deficiencies during inspections. Some of these are significant enough to result in Warning Letters and/or regulatory actions including recalls.

What is going on here? Based on my experience these are some common causes;

Some procedures simply do not meet FDA/QSR requirements and/or expectations;
Often procedures do not clearly and succinctly state the practices which the company intends for their personnel to follow. They can be ambiguous, confusing, or even wrong.
In some cases, personnel are not adequately trained.
In many cases, practices have evolved without updating the procedures or employees are trained to verbal practices rather than written instructions.
Finally, many employees are terrified of the entire inspectional process and may panic when observed or asked questions during an inspection.

Training

My FDA/QSR training program is designed to help employees understand in very practical terms, their regulatory responsibilities and FDA’s expectations for Quality System compliance. The course is based on actual examples which help to increase employee awareness regarding what constitutes a violation in the eyes of the FDA. This in turn helps drive cultural changes to create an environment of compliance. In addition, the course provides valuable insights to help prepare people for the experience of interacting with an FDA investigator or other auditors.

This course is a resource used by many companies to help acclimate new or existing employees to the culture and expectations of working within the medical device industry.

Audits

Simulated FDA-style audits are intended to provide a snapshot of the firm’s current level of compliance and to provide employees with first-hand experience regarding what to expect during an FDA inspection.

Many companies fail to do well in inspections because of a frustrating inability to;

properly and effectively communicate with the investigator;
understand QSR terminology and expectations;
locate documentation requested by the auditor during an inspection
respond to an investigator’s questions during an inspection.

Both the training programs and audits are intended to reduce the likelihood of incurring unexpected outcomes during subsequent FDA inspections.

Testimonials

"Without question Ken Carrier is the number one person we would go to for our independent FDA/QSR audit and training needs. The next best thing to a visit from the FDA is an audit by Ken. Use his services if you truly want to be prepared."

John Coolidge
Sr. Vice President Operations
iWalk, Inc. (BiOM Personal Bionics)

"It has been my pleasure to have been working with Ken Carrier as our internal auditor, consultant and FDA/QSR trainer for fifteen years. Undergoing an FDA/QSR inspection is always challenging, but Ken has done an excellent job of ensuring our Quality Management System is prepared for an inspection."

Michael Zalewski
Vice President – RA/QA/CS
Intersurgical Incorporated

"Regulatory training is a very dry subject but Ken made it interesting by using experiences from his FDA days and clients, some of which were hilarious, and others shocking. He never lost the interest of the group and made the presentation relevant to our particular audience. The audit was an eye-opener, even for those of us accustomed to being audited. He approached it from the perspective of an FDA investigator and identified issues which prepared us for actual FDA inspections."

Nancy Royalty
Director of Quality and Regulatory
Allen Medical Systems (Division of Hill-Rom, Corp.)

"One of our pressing needs when I joined the company was to drive home to our division the importance that compliance to FDA regulations is not optional – it had to become a “way of doing business” and embedded in our culture. I also wanted to drive home the point that these FDA/QSR regulations, if properly complied with, would improve our quality metrics, the quality of our products, and customer satisfaction. We found that Ken’s training courses and reviews of FDA regulatory compliance were the key to making this happen. Ken provides a complete overview of the “why’s and how’s” of compliance appropriate for employees at all levels within the company. But the critical point is that Ken makes these sessions fun and entertaining as well as educational, and he is able to drive home the importance of making compliance not simply a program, but a way of life. This is not subjective: using Ken’s program has yielded dramatic improvements in compliance. I highly recommend Ken’s training programs, simulated FDA-style audits and employee coaching, and consulting services."

Howard Miller
President
Teleflex Arrow Cardiac Care

"Ken Carrier has been consulting for Cytori, our medical device-based cell therapy company, for thirteen years. Ken is a true partner in the process and takes a personal interest in the success of his clients. His thorough audits help fulfill our internal audit obligations and provide invaluable coaching and experience for our employees … Ken has an uncanny knack for finding potential issues before they become a problem. Ken conducts the most robust yet enjoyable FDA/QSR training program I have ever attended! His course enables employees to gain the necessary knowledge to understand and relate to the regulations in a real-world manner."

Doug Arm, Ph.D.
Senior VP, Operations
Cytori Therapeutics, Inc.

"Ken’s auditing and training have been a great help to me at various companies. His approach to auditing is open, non-adversarial, and he presents the audits as a learning opportunity for employees. People respond to him positively. The result is people understand what FDA expects and what is needed to improve the company’s quality system. Ken’s training course in the FDA’s Quality System Regulation is the best I’ve encountered. He directly engages his audience with stories and humor, and uses real-life examples of what to do, and what not to do."

John Sokolowski Independent Consultant

Bio