Web seminar - Implementing cGMPs for Dietary Supplements

04/16/2010 - 1:01pm
Etc/GMT-8

Cost Effective and Convenient - in your office or conference room

Implementing cGMPs for Dietary Supplements

Conducted by David Markovitz
President - GMP Training Systems, Inc.

April 16, 2010

June 2010 is the deadline for ALL companies manufacturing dietary supplements to comply with the new cGMPs for Dietary Supplements (21CFR Part 111). This new regulation is having 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.

  • cGMP for Dietary Supplements Final Rule - FDA's Preamble and Final Rule
  • cGMP for Dietary Supplements 21CFR Part 111 - Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
  • FDA Press Release announcing cGMP for Dietary Supplements
  • FDA's Background info on cGMP for Dietary Supplements
  • FDA Consumer article on new Safe Use of Dietary Supplements

Implementing cGMPs for Dietary Supplements

Part I - 21 CFR 111 Subparts A - H

  • General Provisions
  • Personnel
  • Physical Plant and Grounds
  • Equipment and Utensils
  • Requirement to Establish a Production and Process Control System
  • Production and Process Control System: Requirement for Quality Control
  • Production and Process Control System: Requirements for Components, Packaging, and Labels for Product That You Receive for Packaging or Labeling as a Dietary Supplement
  • Production and Process Control System: Requirements for the Master Manufacturing Record

Part II - 21 CFR 111 Subparts I - P

  • Production and Process Control System: Requirements for the Batch Production Record
  • Production and Process Control System: Requirements for Laboratory Operations
  • Production and Process Control System: Requirements for Manufacturing Operations
  • Production and Process Control System: Requirements for Packaging and Labeling Operations
  • Holding and Distribution
  • Returned Dietary Supplements
  • Product Complaints
  • Records and Recordkeeping

Part III - Questions and Answers

  • Mr. Markovitz will field your questions live on the phone. You will hear all questions and answers from all participants of this seminar.

 

 

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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
GMP100326E - MP3 audio file and Handout materials
Implementing cGMPs for Dietary Supplements 		$397.00 Add to Cart

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:

  • The author and/or co-author of several books and booklets focused on quality optimization.
  • The creator of the GMP Training System™ - for both instructor led and computer based trainings
  • A contributing author to the Journal of GXP Compliance.
  • The creator, host and moderator of FDA web seminars and webcasts.
  • A Member of the Editorial Advisory Board of theJournal of GXP Compliance.
  • An internationally recognized and award-winning speaker and workshop leader.

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