Dietary Supplements cGMP – 21 CFR 111 Compliance

21 CFR part 111 (“the DS cGMP rule”) requires persons who manufacture, package, label, or hold a dietary supplement to establish and follow current good manufacturing practice-the cGMPs. This is to ensure the quality of the dietary supplement and to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record.

This webinar will discuss basic Dietary Supplement CGMP of Part 111 and related requirements, to include:
– Quality Management System / QA / QC
– Personnel, Facilities, Equipment
– Software controls
– Production and Process Controls
– Holding and Distribution
– Complaints and Returns
– Records

Why You Should Attend:

FDA regulates dietary supplements under a different set of regulations than those covering “conventional” foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), Congress defined the term “dietary supplement”, and requires that every supplement be labeled a dietary supplement. Beyond that, the industry was only subject to voluntary quality management systems and controls / GMPs, until the Dietary Supplements cGMPs were published as a “final rule” by the FDA, 21 CFR 111, in 2007.

Failure to follow these requirements results in products being termed “adulterated” or “misbranded” by the Agency. There is confusion in the industry as just what type of manufacturing controls and record keeping, and labeling content is required by the FDA, and this confusion continues to cause regulatory problems for many new and established companies in this industry.

Areas Covered in the Session :

  • History of Dietary Supplement regulation in the U.S
  • The Dietary Supplement Health and Education Act (DSHEA)
  • The key requirements of the Dietary Supplements cGMPs, 21 CFR 111
  • Required steps for cGMP compliance
  • Problem areas, common pitfalls
  • Implementation: Systems, templates and tools

Who Should Attend:

  • Senior Management in Dietary Supplements Industry
  • QA Departments
  • RA Departments
  • R&D Departments
  • Engineering Departments
  • Marketing Departments
  • Consultants
  • Others Tasked with Product, Process, Validations, cGMP Responsibilities
  • Those Interested Consumer Groups
  • Medical and Other Healthcare Professionals, Staff and Office Personnel
  • Start-Ups

FDB3184

John E. Lincoln

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis.

He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.

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  • Presentation from the Speaker
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  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance