Auditing for cGMP Compliance

Length: 2 Days

This training course provides comprehensive insights into auditing practices tailored specifically for cGMP (Current Good Manufacturing Practices) compliance. Participants will delve into the intricacies of auditing processes within the pharmaceutical, biotechnology, and healthcare industries to ensure adherence to regulatory standards.

Learning Objectives:

  • Understand the fundamentals of cGMP and its significance in pharmaceutical manufacturing.
  • Gain proficiency in auditing techniques specific to cGMP compliance.
  • Learn how to identify and mitigate compliance risks within manufacturing processes.
  • Acquire knowledge of regulatory requirements and guidelines governing cGMP.
  • Develop skills in conducting thorough audits and reporting findings effectively.
  • Enhance understanding of corrective and preventive action (CAPA) processes for cGMP compliance.

Audience: Professionals working in pharmaceutical, biotechnology, and healthcare industries involved in quality assurance, compliance, regulatory affairs, auditing, and manufacturing.

Course Outline:

Module 1: Introduction to cGMP Compliance Auditing

  • Overview of cGMP Principles
  • Importance of Compliance Auditing
  • Evolution of cGMP Regulations
  • Role of Auditing in Quality Assurance
  • Key Concepts in Auditing for cGMP Compliance
  • Introduction to Audit Planning

Module 2: Regulatory Framework and Guidelines

  • FDA Regulations for cGMP Compliance
  • International Standards (ICH, ISO) for Pharmaceutical Manufacturing
  • EMA Guidelines for Good Manufacturing Practice
  • Regulatory Expectations for Documentation and Record-Keeping
  • Understanding Inspection Procedures
  • Interpreting Regulatory Guidance Documents

Module 3: Auditing Techniques and Methodologies

  • Risk-Based Approach to Auditing
  • Developing Audit Checklists and Protocols
  • Sampling Techniques in Auditing
  • Interviewing Skills for Auditors
  • Document Review Strategies
  • Utilizing Technology in Auditing Processes

Module 4: Risk Identification and Mitigation Strategies

  • Identifying Critical Control Points in Manufacturing
  • Assessing Potential Risks in Production Processes
  • Root Cause Analysis in Auditing
  • Implementing Risk Mitigation Plans
  • Preventive Measures for Common Compliance Issues
  • Continuous Improvement Strategies

Module 5: Conducting Effective Audits and Reporting

  • Preparing for On-Site Audits
  • Conducting Opening and Closing Meetings
  • Observation and Evidence Collection Techniques
  • Documenting Audit Findings Accurately
  • Communicating Audit Results to Stakeholders
  • Constructing Comprehensive Audit Reports

Module 6: CAPA Processes for cGMP Compliance

  • Understanding Corrective and Preventive Action (CAPA)
  • Identifying CAPA Triggers
  • Root Cause Analysis Techniques for CAPA
  • Developing CAPA Plans
  • Implementing CAPA Measures Effectively
  • Monitoring and Evaluating CAPA Effectiveness