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Learn from FDA 483's and from detailed EIR inspection reports  what FDA inspectors look for, what questions they ask and if company's response is satisfactory.  483's and EIR's typically are not available from FDA's public website.

Labcompliance On-line Audio Seminar

This seminar has been recorded and is available on CD and for instant download. All reference material as listed below and more is available on a special seminar website. The website is regularly updated with most recent information. In case there are questions related to the topic, they can be submitted through a web form and will be answered by the speaker. For ordering info click here
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On-line Audio Seminar 245

Implementing FDA's 21 CFR 111 for Dietary Supplements

Introduction, Strategies and Tool-kit for Implementation


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In June 2007, the FDA issued the Dietary Supplement Current Good Manufacturing Practice (CGMP) Final Rule 21 CFR Part 111. The deadline for all dietary supplement companies is June 2010. The rule requires that the proper controls be in place for dietary supplements during manufacturing, quality control, packaging, labeling, and holding, This has a high impact on manufacturers, distributors and importers of dietary supplemental products. Manufacturers are unsure on how to interpret the rule but the FDA is coming writing 483 observations and warning letters.

Questions related to the CGMP rule for dietary supplements are:

  • Who is affected by the rule?
  • Are there USP or other monographs for quality control
  • Do USP general chapters apply for Part 111?
  • How does the rule compare with drug cGMPs: more or less stringent?
  • Do manufacturers of ingredients have to comply with Part 111
  • How should "identity tests" be performed?
  • Do we need an independent quality control unit?
  • What are FDA inspectors looking at during inspections?
  • What are the most frequently found FDA observations?
  • The rule requires records to be readily available: which records, when, how quickly?

How does the on-line audio seminar help:

Answers will be presented by Dr. Ludwig Huber in a new interactive audio seminar. During the seminar, the speaker will give an overview of key requirements and strategies for  implementation.  After the seminar, an extensive list of reference material like SOPs, gap analysis, implementation plan templates and examples will help immediate and cost effective implementation. .

During the interactive presentation you learn:

  • History, current status and future of the rule
  • Requirements overview overview
  • Going through subparts: Personnel, facility, equipment, production and process control, quality control,, raw material, laboratory operations, manufacturing controls, packaging and labeling, records and record keeping
  • Comparison with drug and general food GMPs
  • The purpose of the interim final rule
  • Examples of typical FDA 483 observations
  • Procedures for identity and strength/potency tests
  • Practical recommendations for implementation
  • Most frequently asked questions and answers

Get 10+ Documents To Do it Right The First Time:
download from special seminar website

  • SOPs:
    - Document Management and Control for GxP Compliance
    - Training for GMP Compliance
    - FDA inspections: Preparation - Conduct - Follow-up
    - Responding to 483 Inspectional Observations
    - Auditing Suppliers
    - Internal Auditing for 21 CFR Part 111 Compliance
    - Sampling for Analytical Testing
  • Checklist: Implementing 21 CFR Part 111
  • Most frequently asked questions and answers about 21 CFR Part 111
  • Case Study: How to Respond to Part 111 Related 483's and Warning Letters
  • Case Study: Real FDA Inspection for 21 CFR Part 111: Without  483 Observations
  • Case Study: Real FDA Inspection for 21 CFR Part 111: With 483 Observations
  • FDA Establishment Inspection Reports (EIR's) related to 21 CFR Part 111
  • FDA 483's Inspectional Observations related to 21 CFR Part 111

Who should attend?

  • Everyone involved in manufacture, testing, packaging, or labeling of dietary supplements
  • Quality assurance
  • Quality control
  • Regulatory affairs
  • Training departments
  • Documentation department
  • Consultants
  • Auditors

Date, time and duration

Order at any time, replay at any time, download the reference material at any time.

How to order

Pick one of the options in the table that fits your needs.

Recorded seminar - Web Download

  • Multiple persons - single site
  • Learn at your desk, meet in a seminar or conference room or share the audio file and reference material at your site.
  • Order includes all reference material.

US$ 399.-
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Recorded seminar - CD

  • Get the CD in your mail
  • Order includes all reference material.

US$ 399.-
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Special offer for Labcompliance Usersclub Members
Recorded Seminar- CD or Web download.

  • Order includes all reference material.
  • for Usersclub information and registration, click here

US$ 299.-
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About audio seminars

Online audio seminars are presented over the phone. During the live presentation attendees can:

  1. Listen to the presentation
  2. Study the printed Powerpoint slide material
  3. Watch the slides on a computer
  4. Watch the slides on a video screen in a seminar room
  5. Ask questions through email and a web form before, during and after the seminar

About Dr. Ludwig Huber

Dr. Ludwig Huber is the editor and author of Labcompliance. He has been conducting over 300 web and audio or video based seminars since 15 years and and he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health agencies.

Dr. Ludwig Huber is a frequent presenter at IVT conferences and has been awarded as the 'Presenter of the Year' out of 170 speakers. This photo is from IVT's conference on Network Qualification with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and compliance, for example: Validation of Computerized Analytical and Networked Systems. He was or still is a member of several committees, e.g., of the GAMP® Special interest group (SIG) on Laboratory Computers, PDA Part 11 task force, IVT task force on network infrastructure qualification and the European Compliance Academy. He frequently visited FDA in Rockville, VA, and participated in panel discussions with FDA professionals. For feedback from attendees of seminars and  for other information on Dr. Ludwig Huber, click here.