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.
Learning Objectives:
- Effectively evaluate audit and report findings
- Identify critical components for a good audit report
- Conduct an audit using an audit trail and checklist
- Understand the concepts behind compliance auditing
- Increased knowledge of cGMP concepts and regulatory requirements related to auditing
- Prepare and conduct audits using an audit trail and checklists
- Identify the critical competencies needed to be a conscientious auditor
RAPS - This course has been pre-approved by RAPS as eligible for up to 8.0 credits towards a participant's RAC recertification upon full completion.
Course Content
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
Course Provider
Ms Kelly Thomas,
Vice President ,
Stallergenes GreerMs. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.
Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.
Who Should Attend
- This course is 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
