QMS Technical Writing for Dietary Supplement Q&C Training Event

Virtual Learning

May 11 – 12, 2023

Course Overview

This course is 8-Hours. In this course we will cover 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. In part one we will cover types of documentation and associated best practices. Particular emphasis will be given to the procedures and documentation required for when encountering deviations or unexpected occurrences and the associated material reviews and CAPA process needed.
In part two of the course we will take a deeper dive into internal auditing and the audit documentation. We will also discuss how to implement corrective actions for non-conformances found in internal audits and how to evaluate their effectiveness.
We will review and discuss general examples of how-to best handle QMS documentation situations
PART I – QMS Documentation
Documentation Requirements and Best Writing Practices
Programs and Policies, Standard Operating Procedures (SOP), MMRs & BPRs, Specification Sheets, Forms and Logs
Investigative and Corrective Documentation
Deviation /Non-Conformance Reports, Material Review, Corrective and Preventative Action (CAPA) reports
Documentation Protocols
Good Documentation Practices, Change Control Document and Revision Control, Record Retention, Requirements for Electronic Records, Training
PART II – 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

Part 1 - May 11, 2023 1:00pm.-5:00pm Eastern Time
Part 2 - May 12, 2023 1 :00pm-5:00pm Eastern Time

Cost: $800.00
Find out more about the:
Quality and Compliance Training Event

Attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification.

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