ComplianceOnline

The New Dietary Supplement Good Manufacturing Practices

Instructor: John Suzuki
Product ID: 700642
  • Duration: 60 Min

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Oct-2007

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This New Dietary supplements webinar will highlight from a quality perspective the introductory requirements of these new CGMP regulations and examine methods and strategies for meeting these new requirements.

Why Should You Attend:

The FDA has issued the final rule (June 22, 2007) establishing regulations to require current good manufacturing practices (CGMPs) for dietary supplements. These new regulations will require that dietary supplement manufacturers put into place proper controls to insure that dietary supplements are processed in a consistent manner and meet quality standards. To limit the disruption to dietary supplements businesses, the final rule has been staggered over a three-year period based on the size of the organization. The final CGMPs is effective June 2008 for large companies, June 2009 for companies with less than 500 employees, and June 2010 for companies with less than 20 employees. This presentation will highlight from a quality perspective the introductory requirements of these new CGMP regulations and will examine methods and strategies for meeting these new requirements, especially for organizations with limited resources.

Areas Covered in the seminar:

  • General Provisions.
  • Personnel.
  • Physical Plant.
  • Equipment and Utensils.
  • Production and Process Control Systems.
    • Establish Production and Process Control System
    • Requirements for Quality Control
    • Requirements for Components, Packaging and Labels
    • Requirements for the Master Manufacturing Record
    • Requirements for the Batch Production Records
    • Requirements for Laboratory Operations
    • Requirements for Manufacturing Operations
    • Requirements for Packaging and Labeling Operations
  • Holding and Distribution.
  • Returned Dietary Supplements.
  • Product Complaints.
  • Records and Record Keeping.
  • Strategies for implementation.

Who Will Benefit:

This webinar will provide basic information about the CGMPs for supplement manufacturers or for new companies that are anticipating manufacturing new dietary supplements. The individuals who will benefit include:

  • End users responsible for the various aspects of day-to-day production of dietary supplements
  • Physical plant and maintenance personnel
  • Operators of automated, mechanical or electronic manufacturing equipment
  • Quality control and quality system personnel
  • Laboratory and lab testing personnel
  • Production and process control personnel
  • Packaging and labeling personnel
  • Manufacturing engineers and personnel
  • Regulatory personnel
  • Plant managers
  • Quality system auditors
  • Consultants

Instructor Profile:

John Suzuki, is the founder and owner of JKS & Associates, a consulting firm that specializes in the implementation of quality systems for the regulated industries and in equipment and automated computer systems validation. He has extensive experience in the laboratory and diagnostics industries and has consulted with both large and small companies in the pharmaceutical, biotech, and medical device industries. He has participated in several industry and FDA joint working groups and has experience with implementing FDA-type quality systems in several types of companies and industries.

Follow us :
Validation, Verification and Transfer of Analytical Methods
Upcoming In-person Seminars by EX-FDA OFFICIALS

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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