QMS Technical Writing & Audit Observation Report Writing

Virtual Learning

January 27 – 28, 2022

Course Overview

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 - January 27, 2022 1:00pm.-5:00pm Eastern Time
Part 2 - January 27, 20221:00pm-5:00pm Eastern Time

Cost: $700.00

*Completion of the course means being in attendance 95% of the log in time*
Attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification.