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Cost Effective – Time Effective –
In your Conference Room or Office
Implementing cGMPs for
Dietary Supplements
21CFR Part 111
Conducted by David Markovitz
President, GMP Training Systems, Inc.
May 29, 2008
The clock is ticking!
On June 22, 2007 FDA
released the long awaited
cGMPs for Dietary Supplements.
These go into effect in June 2008. This new
regulation will have a profound effect on the manufacturers and distributors
of dietary supplement products. This workshop is designed to examine this
new regulation in detail. At the conclusion of this seminar, you should be
able to develop a checklist of what you need to do in order to comply with
this new regulation.
Conducting this web seminar is David Markovitz,
President of GMP Training Systems, Inc. David's career includes nine years
(1989 - 1998) where he headed all the education and training activities for
Nutrilite Products, Inc., one of the pre-eminent manufacturers of dietary
supplements. David knows this business.
In this unique web
seminar format, lasting just one hour, you will be able to
follow along with a PowerPoint presentation,
ask questions, and interact with Mr. Markovitz. An outline of this
seminar and Mr. Markovitz' qualifications can
be found below.
Bonus Resource Documents
You will
be able to download the following resource
documents upon registration.
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cGMP for Dietary Supplements
Final Rule - FDA's Preamble and Final Rule
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cGMP for Dietary Supplements 21CFR
Part 111 - Current Good Manufacturing Practice in Manufacturing,
Packaging, Labeling, or Holding Operations for Dietary Supplements
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FDA Press Release
announcing cGMP for Dietary Supplements
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FDA's Background info on
cGMP for Dietary Supplements
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FDA Consumer article on new
Safe Use of Dietary Supplements
Implementing cGMPs
for Dietary Supplements
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Part I 21 CFR 111 Subparts A -
H
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General Provisions
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Personnel
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Physical Plant and Grounds
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Equipment and Utensils
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Requirement to Establish a Production and
Process Control System
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Production and Process Control
System: Requirement for Quality Control
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Production and Process Control System:
Requirements for Components, Packaging, and Labels for Product
That You
Receive for Packaging or Labeling as a Dietary Supplement
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Production and Process Control System:
Requirements for the Master Manufacturing Record
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Part II 21 CFR 111 Subparts I -
P
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Production and Process Control System: Requirements for the
Batch Production Record
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Production and Process Control System: Requirements for
Laboratory Operations
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Production and Process Control System: Requirements for
Manufacturing Operations
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Production and Process Control System: Requirements for
Packaging and Labeling Operations
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Holding and Distribution
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Returned Dietary Supplements
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Product Complaints
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Records and Recordkeeping
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Part III Questions and Answers
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Register now!
Don’t like to order online?
Call us at 714-289-1233
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 web location to download the handout materials.
We accept Visa, MasterCard, and
American Express (AMEX). All prices are in US
dollars.
Note International shipments: If ordering the CD for shipment,
additional shipping charges will be added for all international shipments.
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cardholder named on the credit card.
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EXACTLY as it appears on
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Get the CD and handout
GMP080208E - CD and
Handout materials
Implementing cGMPs
for Dietary Supplements
CD price includes all HANDOUT MATERIALS and audio
CD. CD will be shipped three weeks after the seminar |
$397.00 |
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Instructor
David Markovitz
David Markovitz 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. With a corporate
background of management positions in Manufacturing Operations for four
different companies over two decades, David knows first hand how to overcome
the challenges in implementing quality systems.
David
honed his expertise on Quality Systems when he 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 and develop a Quality Systems approach.
A
leading thought leader in the FDA regulated industry, Mr. Markovitz is:
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The author and/or co-author of several books and booklets
focused on quality optimization.
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The creator of the GMP Training System™ - for both instructor
led and computer based trainings
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A contributing author to the Journal of GXP Compliance.
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The creator, host and moderator of FDA web seminars and webcasts.
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A Member of the Editorial Advisory Board of the
Journal of GXP Compliance.
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An internationally recognized and award-winning speaker and
workshop leader.
Please forward this to your colleagues who may be
interested.
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