GMP

COURSE OVERVIEW

This training program is designed to provide participants with a comprehensive understanding of Good Manufacturing Practice (GMP) audits in the pharmaceutical, food, and other regulated industries. The course will cover the fundamental principles of GMP audits, including regulatory requirements, audit planning, execution, and reporting. Participants will learn how to conduct effective GMP audits, identify non-compliance issues, and implement corrective and preventive actions.

COURSE OBJECTIVE

1. ·         To define the activities and requirements of GMP Audit
2. ·         To identify the roles and benefits of GMP Audit in a Food Safety Management System
3. ·         To learn how to plan, perform and monitor GMP Audit

WHO SHOULD TAKE THIS COURSE?

1. ·         Quality Assurance (QA) and Quality Control (QC) Personnel
2. ·         Regulatory Affairs Professionals
3. ·         Production and Manufacturing Managers
4. ·         Auditors and Compliance Officers
5. ·         Anyone involved in GMP compliance and audits in the pharmaceutical, food, or other regulated industries.

 COURSE OUTLINE

1.    Introduction

■    Objectives

■    Description of GMP Audit

■    Scope of GMP Audit

■    Benefits of GMP Audit

■    The key principle of GMP Audit

■    The role of GMP Auditor

2.    Managing the GMP Audit program

■    Process Flow for Managing of an audit program

■    Authority of audit program

■    establishing the audit program

■    Audit program implementation

■    monitoring and reviewing the audit program

3.    Audit Activities

■    Overview of Audit Activities

■    initiating the audit

■    Conducting Document Review

■    preparing for Onsite audit activities

■    Conducting on-site audit activities

■    Preparing, approving & distributing the audit report

■    Completing & Conducting Follow up

4.    Audit Format

5.    Conclusion

Assessment

After completing the session, the students will be evaluated through a multiple-choice final exam. Once the final exam is cleared the passing grade should be 70% then it is considered as an end of course.

Duration/Discount

The training session is scheduled to last for one day.  Skedmia intends to provide discounts to a starting of 4 to 5 individuals. 

Disclaimer

The author expressly disclaims responsibility for the accuracy, completeness quality of the material given. This training does not imply that the provide materials will ensure student mastery. This insinuates that it is the responsibility of the students to further improve the knowledge and skills gained through this training through in-field experiences and or other methods as applicable.