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
Day 1: Foundations of GMP Auditing & Regulatory Requirements
Welcome & Course Introduction
- Overview of GMP and its importance in quality assurance
- Understanding the role of auditing in compliance & risk management
GMP Regulatory Frameworks
- FDA, EU GMP, WHO, PIC/S, and other global guidelines
- Key differences and harmonization efforts
Types of GMP Audits & Audit Planning
- Internal audits vs. supplier audits vs. regulatory inspections
- Developing an effective audit plan & checklist
Conducting a GMP Audit - Step-by-Step Guide
- Opening meetings & setting audit objectives
- Interview techniques & document review best practices
Identifying Non-Conformities & Risk Assessment
- Categorizing major vs. minor observations
- Evaluating risk impact & root cause analysis
Q&A & Recap of Day 1
Day 2: Corrective Actions, CAPA, & Regulatory Inspections
Recap of Day 1 & Key Takeaways
Writing Effective Audit Reports
- Key elements of a strong audit report
- Using clear, objective, and actionable language
Coffee Break
CAPA (Corrective and Preventive Actions) Implementation
- Addressing audit findings with root cause analysis
- Developing CAPA plans & ensuring follow-ups
Preparing for Regulatory Inspections
- Mock audits & real-world case studies
- How to respond to FDA/EU regulatory auditors
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.
