Limited time offer: REGISTER 1 for 1 before 30 April!

GMP Auditing for Quality Assurance Training Course (G07)

26 - 27 Jun 2025 | 9.00-5.00pm SGT
The Chevrons, 48 Boon Lay Way, Singapore 609961

IN-PERSON!

Overview

Auditing is a critical function within a pharmaceutical company. It provides management with information about how effectively the company controls the quality of their processes and products. Auditors must perform their jobs competently to ensure their company’s compliance with pharmaceutical USFDA GMP regulations and other quality standards like ICH Q10. This Auditing for GMP course is specifically designed to address the challenges of GMP auditing for the pharmaceutical industry and present the basic competencies required to effectively perform the auditor's assigned responsibilities.

What You Will Learn

  • Challenges of GMP auditing for the pharmaceutical industry
  • Present the basic competencies required to effectively perform the auditor's assigned responsibilities
  • Contribute to the improvement of auditor performance within a regulated industry

Course Modules

  • Background Information
  • Auditing Department Basics
    • Exercise: Be, Know, Do
  • Traits/Skills of a Good Auditor
    • Group discussion: Fishbone Diagram
    • Group discussion: Exercise: Potential Interview Problems
    • Group work: Exercise: Getting it Right
  • GMP Background Information for Auditors
    • Exercise: Home Base Worksheet
    • Exercise: Preamble Activity
  • Pre-Audit Information
  • Conducting the Audit
    • Group work: Common Items to look for in an Audit

  • Post Audit

    • Group work: Classifying, Managing, Justifying your findings

    Exercise: cGMP Compliance

  • Exercise: Ranking – GMP Observations
  • Group work: Root Cause Analysis 5 Why’s
  • Group work: Root Cause Analysis From Fishbone

 

  • Additional Resources and Worksheets/Checklists
    • Calibration, Equipment and Validation Information
    • Audit Strategies
    • Additional Considerations for GMP Auditing
    • Audit Report Example 1, Example 2, Example 3

Who Should Attend

  • Recommended for individuals with two to three years of direct experience working with the USFDA and PIC/S GMP guidelines who want to develop additional expertise in GMP Auditing
  • New auditors or individuals wanting to become auditors
  • Professionals who are responsible for conducting internal or vendor GMP audits
  • Suppliers and others who are audited, such as quality assurance and quality control specialists, validation scientists, manufacturing supervisors, technical support personnel, engineers, and all levels of management

Led by:

Shanshan Liu
Technical Director
No Deviation Pte Ltd

 

Registration

Limited time offer: REGISTER 1 for 1 before 30 April!

Member - US$ 895 / SGD 1,195
Non-ISPE Member - US$ 1,095 / SGD 1,485
Government / Academia / Emerging Economies - US$ 550 / SGD 730

Register Now