21 CFR Part 111 - Master Manufacturing Records and Batch Production Records

Speaker

Instructor: Andy Swenson
Product ID: 706762

Location
  • Duration: 60 Min
The single most critical document in an FDA inspection is the master manufacturing record and associated batch production record. While the 21 CFR Part 111 regulations have a checklist of elements the documents must contain, it can be difficult to translate that into a working document. This training will review the basic principles of what an MMR & BPR must contain and give you tools to create an “FDA Acceptable” document.
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Areas Covered in the Webinar:

  • The contents an MMR must contain
  • The contents a BPR must contain
  • Translating the regulatory requirements into a workable document that is quality and production friendly
  • What quality, warehouse and production responsibilities should be in an MMR
  • The required special instructions and corrective actions
  • How to present and record information in the MMR & BPR
  • What the creation process (flow chart) should look like
  • Identifying which departments should be involved in the creation of an MMR

Who Will Benefit:

  • Dietary supplement manufacturers
  • Employees involved in the creation of an MMR & BPR
  • Quality, Manufacturing and R&D/PD departments
  • Executives responsible for the MMR & BPR
Instructor Profile:
Andy Swenson

Andy Swenson
VP of Quality & Product Development, Dietary Supplement Experts, LLC

Andy Swenson has been in the dietary supplement industry for over 25 years. Starting as a machine operator in the encapsulation department back in the mid-90's he quickly fell in love with the industry and its unique approach to providing solutions for people looking for alternative therapies. As his career progressed his expertise shifted from operating machines to product development and, for the last 15 years, quality. In 2009 the 21 CFR Part 111 dietary supplement cGMPs were introduced and he saw this as an opportunity to be on the forefront of developing compliant systems. Since that time, his focus has been on helping companies navigate the regulations while coming up with realistic and budget friendly solutions. Andy has assisted many companies with FDA inspections and responses, consent decree management, and the proactive implementation of required cGMP quality systems. He is currently a consultant at Dietary Supplement Experts and oversees the cGMP compliance sector. Between Andy and Curtis Walcker (his DSE business partner who is responsible for 21 CFR Part 101 labeling compliance), they offer a complete package for dietary supplement companies looking to reduce regulatory risk.

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