SOP and Recordkeeping

The FDA's 21 CFR 111 is a performance-based regulation for the dietary supplement industry. If you manufacture, package, label or hold a dietary supplement, you must establish and follow Current Good Manufacturing Practices (cGMPs) to ensure the quality of the dietary supplement. You must also make sure that the dietary supplement is packaged and labeled as specified in the master manufacturing record. While cGMPs instruct you on what you need to accomplish, there is very little detail on how to go about it.

The good news is that you have a great deal of flexibility in how to accomplish the requirements outlined in the cGMPs. The downside is that you have to write SOPs that detail how you will meet those requirements. This training course will guide you through the construction of an SOP and recordkeeping system and then walk you through the process of creating SOPs and records.

At the end of NSF's dietary supplement SOP training, you will know and understand:

• Requirements of the critical components for compliance with 21 CFR 111
• Recordkeeping requirements for compliance with 21 CFR 111
• How to construct your SOP system
  • Your SOP on SOPs
  • Locations and availability
  • Writing SOPs
  • Change control
  • Part 11 (briefly)
• Records
  • Forms
  • Batch production records
  • Dos and Don'ts
• Summary of required SOPs and records

• Management
• Marketing
• Quality control/assurance
• Packaging
• Sales
• Laboratory operations
• Product development
• Suppliers and distributors
• Regulatory affairs
• Legal

Course instructors will be selected from the following:

Nicole Leitz - Nicole Leitz has more than 20 years of experience in the 21 CFR regulated industries. She has written and presented numerous training sessions on quality system elements and best cGMP practices to corporate clients and at national conventions. Nicole is also an experienced remediation consultant. She has advised, and written documentation such as SOPs and WIs and has completed root cause investigations, CAPAs and complaints for corporate clients.

Nicole has a Master of Science degree in organic chemistry from Bucknell University and a Bachelor of Science in ACS chemistry from Hope College.

Norman Howe - Norman Howe is an experienced quality consultant. Norman has taught a course in quality systems as adjunct faculty at the University of Michigan, Ann Arbor. He serves as an expert witness in FDA-regulated product quality cases.

Previously, Norman was the plant manager of a pharmaceutical plant with BASF and was responsible for manufacturing, quality assurance, engineering, maintenance, contract manufacturing and a small product development group.