cGMP Compliance Series Teleseminar: Variances

cGMP Compliance Series Teleseminar: Variances

Presented: November 1, 2011

Published: Tuesday, November 1, 2011

Customer complaints, product returns, out-of-specification lab results, calibration failures, manufacturing deviations … all of these are serious issues no business in the dietary supplement industry wants to face. But variances--an exception or departure from approved protocol--occur and have to be prepared for and managed under dietary supplement cGMP. The cGMPs apply to all domestic and foreign companies that manufacture, package, label, or hold dietary supplements, including those involved with the activities of testing, quality control, packaging and labeling, and distribution in the United States.

Under FDA regulations for cGMPs, variances must be detected, investigated, documented, explained, and addressed. With the right guidance, information, and tools, the process is much easier.

This AHPA educational teleseminar and accompanying standard operating procedure (SOP) templates (more than 30 are included) will assist dietary supplement marketers, manufacturers, distributors, and suppliers with a thorough understanding of the following key variance issues:
  • FDA regulations and how they apply to your business
  • A review of variance issues with practical guidance on how to address them from a panel of industry cGMP experts. Topics include:
  • Customer complaints and product returns
  • Out-of-specification investigations
  • Corrective and preventative actions
  • Product recalls
  • Reportable foods, recordkeeping, and SOPs

Materials in this packet include:

  • Teleseminar presentation files
  • Teleseminar audio file
  • More than 30 fully customizable examples of SOP reports and log forms, including:
  • Unplanned Events
  • Calibration Failures
  • Nonconforming Materials
  • Planned Deviations
  • Production Failure
  • Corrective & Preventative Actions
  • Out-of-specification Investigations
  • Customer Complaints
  • Returned Goods
  • Reportable Foods
  • Recall Procedure
Member Price: $220.00
Non-Member Price: $520.00



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