QMS Technical Writing & Audit Observation Report Writing-SSE Virtual Training

Virtual Learning

April 21 – 22, 2022

Course Overview

QMS Documentation Audit Observation Writing
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 of the course, we will take a deeper dive into internal auditing and the audit documentation.

PART I – QMS Documentation

· Documentation Requirements and Best Writing Practices

· Programs and Policies, Standard Operating Procedures
(SOP), MMRs & BPRs, Specification Sheets, Forms and

· 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

Day 1: Thursday April 21, 2022

Day 2: Friday April 22, 2022

Start Time: 11:00 am to End Time 3:00 pm Eastern Time

Course Duration: 8-Hours

Cost: General Registration: $800.00

A Certificate of Attendance will be provided upon completion of the course. Attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification.
Course log in details will be sent in a separate email.