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.
Perfect for professionals seeking to strengthen their auditing skills and contribute to maintaining high standards in pharmaceutical and healthcare industries
Perfect for professionals seeking to strengthen their auditing skills and contribute to maintaining high standards in pharmaceutical and healthcare industries
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
Agenda
GMP Auditing for Quality Assurance - 2-Day Course AgendaDay 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
- 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
- Take the next step in mastering GMP auditing! This intensive 2-day training will equip you with the knowledge, tools, and confidence to ensure compliance and quality excellence.
Course Provider
Kelly Thomas,
