QMS Technical Writing Course for Dietary Supplements

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.

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