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Lessons from Recent FDA Actions
Tylenol recall and Genzyme $175M fine
Conducted by David Markovitz
Founder and President - GMP Training Systems, Inc.
May 21, 2010
McNeil Consumer Healthcare, manufacturer of Tylenol and other products, has come under intense scrutiny from FDA at two of their plants. They have massive recalls in place and have suspended production until GMP problems are addressed and resolved.
Genzyme expects a Consent Decree (Federal Court Injunction) and has budgeted $175M for a court ordered fine for GMP problems.
During this web seminar, we will examine the FDA-483 Observation reports and Warning Letters issued to both companies. We will also review McNeil's response to the FDA-483 and Warning Letter.
These are very serious situations and will have a huge impact on their customers as well as their employees. There are numerous lessons to be learned from both these situations. A proven method of avoiding problems with FDA is to learn from peoples’ problems. That’s what is seminar is designed to do.
Leading this seminar will be David Markovitz, Founder and President of GMP Training Systems, and author of GMP Makes Good Business Sense (an Ebook) and the popular GMP Training System line of products for internal trainers.
In this unique web seminar format, lasting just one hour, you will be able to follow along on several resource documents, ask questions, and interact with Mr. Markovitz. Mr. Markovitz' qualifications can be found below.
The resource documents will be available for download as soon as your registration is processed.
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All registrations include handout materials. Once you’re registered, you will receive via e-mail (the e-mail address you provide in your registration) the presentation handout materials the day before the seminar.
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|Get the MP3 file and handout
GMP100520E - MP3 audio file and Handout materials
Lessons from Recent FDA Actions
David is the President of GMP Training Systems, Inc. an education, training, and consulting firm whose mission is to help organizations improve their productivity, quality, and long-term profitability by implementing strategies focused on innovation, continual improvement and optimization of work systems and processes throughout all levels in an organization. David is:
The author and/or co-author of Becoming the Best: Making Optimization Happen, GMP Makes Good Business Sense, The Team Process Improvement Workbook, Innovation Resource Handbook: A Practical Blueprint for Leaders in Industry, Government, and Education, 212 Optimization Tips to Improve Performance, Productivity, and Profits, and Essential Tips for a Successful Speech.
- The creator of the popular GMP Ready-to-Use Training System™.
- A contributing author to the Journal of GXP Compliance.
- The creator, host and moderator of FDA-focused audio seminars and web seminars.
- A Member of the Editorial Advisory Board of the Journal of GXP Compliance.
- An internationally recognized and award-winning speaker and workshop leader.
- President of the Los Angeles chapter of the National Speakers Association (2003-04), the world’s leading society for experts who speak professionally. Listed in the Who’s Who of Professional Speaking.
David had the rare privilege of assisting Dr. W. Edwards Deming, the 20th century’s leading quality guru, in several of his famed Four-Day Seminars. David created and led the Deming Roundtable, an intensive year-long cooperative effort involving eight different organizations working to implement Deming’s teachings.
An internationally recognized and award winning speaker and workshop leader, David has been invited to present at conferences and meetings throughout the world. He is the recipient of the Gold Microphone Award (National Speakers Association) and the 2004 winner of the prestigious Connie Award for Professionalism on the Speaking Platform.
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