QMS Technical Writing Course for Dietary Supplements

Upcoming

Virtual Learning
May 26 – 27, 2022

2 days

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Virtual Learning
July 7 – 8, 2022

2 days

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Virtual Learning
August 11 – 12, 2022

2 days

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About This Course

This training covers the documentation needed for a robust quality management system (QMS) when manufacturing dietary supplements, as well as the best practices to follow when conducting internal audits. The first section of the course covers types of documentation and associated best practices. Emphasis will be placed on the procedures and documentation required for when deviations or unexpected occurrences are encountered and the associated material reviews and CAPA process needed.

In the second section, we take a deeper dive into internal auditing and audit documentation. We also discuss how to implement corrective actions for nonconformances found in internal audits and how to evaluate their effectiveness. We explore how to best handle QMS documentation situations as well as review examples.

Key Learning Objectives

At the end of the QMS technical writing course for dietary supplements, you will know and understand:

  • Documentation requirements and writing best practices
  • Investigative and corrective documentation
  • Documentation protocol
  • Internal audit basics and best practices

Course Outline

Part One - QMS Documentation

  • Documentation requirements and writing best practices
  • Programs and policies, standard operating procedures (SOPs), MMRs and BPRs, specification sheets, forms and logs
  • Investigative and corrective documentation
  • Deviation/nonconformance reports, material review and CAPA reports
  • Documentation protocols
  • Good documentation practices, change control, document and revision control, record retention, requirements for electronic records, training

Part Two - Audit Observation Reporting

  • Internal audit basics and best practices
  • Introduction to internal auditing
  • Using checklists
  • Conducting the audit
  • Incorporating regulatory and cGMP requirements in internal auditing
  • 21 CFR 111 and 21 CFR 117 for warehousing and distribution
  • Supplier program requirements
  • Records and procedures
  • Turning audit findings into useful information and continuous improvement
  • Communicating audit reports
  • Importance of a good CAPA system

Who Should Attend?

  • Management
  • Manufacturing
  • Quality control/assurance
  • Packaging
  • Marketing
  • Auditing
  • Suppliers and distributors
  • Regulatory affairs

Instructor

Vijay Bachus - Vijay Bachus is a contracted consultant at NSF Health Sciences, LLC, offering subject matter expertise in cGMP compliance related to 21 CFR Parts 111 and 117. He is experienced in guiding top industry leaders through strategic growth and catapulting business owners to success. Vijay currently owns a successful consulting company specializing in facility and business operations compliance. He lives in Longmont, Colorado, where he enjoys spending time with his family, hiking, gardening and appreciating the natural beauty of the state. He holds a Bachelor of Science in molecular, cellular and developmental biology from the University of Colorado.