cGMP Audits and Inspections

Length: 2 days

This comprehensive training course on cGMP (Current Good Manufacturing Practices) Audits and Inspections is designed to equip participants with the necessary knowledge and skills to effectively conduct audits and inspections in accordance with regulatory standards. Participants will gain a deep understanding of cGMP requirements, audit methodologies, and inspection techniques to ensure compliance and product quality.

Learning Objectives:

  • Understand the fundamentals of cGMP and its significance in pharmaceutical manufacturing.
  • Learn the principles and procedures for conducting cGMP audits and inspections.
  • Explore regulatory requirements and guidelines governing cGMP audits and inspections.
  • Gain proficiency in identifying non-compliance issues and implementing corrective actions.
  • Develop strategies for preparing and managing cGMP audits and inspections effectively.
  • Enhance communication and documentation skills necessary for successful cGMP audits and inspections.

Audience: This course is suitable for professionals working in the pharmaceutical, biotechnology, and medical device industries, including:

  • Quality Assurance (QA) Managers
  • Regulatory Affairs Specialists
  • Compliance Officers
  • Manufacturing and Operations Managers
  • Auditors and Inspectors
  • Anyone involved in cGMP compliance and quality management.

Course Outline:

Module 1: Introduction to cGMP

  • Fundamentals of cGMP
  • Importance of cGMP compliance
  • Evolution of cGMP regulations
  • Key concepts in cGMP
  • Impact of non-compliance
  • Overview of cGMP in pharmaceutical manufacturing

Module 2: Regulatory Requirements

  • FDA regulations on cGMP
  • International guidelines (ICH, WHO) for cGMP
  • Regulatory inspections and audits
  • Documentation requirements
  • Role of regulatory agencies in enforcing cGMP
  • Recent updates and trends in cGMP regulations

Module 3: Audit Preparation

  • Planning an audit
  • Establishing audit objectives
  • Developing audit checklists
  • Selecting audit team members
  • Conducting pre-audit meetings
  • Creating an audit schedule

Module 4: Audit Execution

  • Conducting opening meetings
  • Interviewing personnel
  • Reviewing documentation and records
  • Observing manufacturing processes
  • Identifying non-compliance issues
  • Documenting audit findings

Module 5: Inspection Procedures

  • Types of regulatory inspections
  • Preparation for regulatory inspections
  • Conduct during regulatory inspections
  • Responding to regulatory findings
  • Interaction with regulatory inspectors
  • Follow-up actions post-inspection

Module 6: Corrective Actions and Follow-Up

  • Developing corrective action plans
  • Implementing corrective actions
  • Monitoring and verifying effectiveness of corrective actions
  • Documentation of corrective actions
  • Communicating with stakeholders
  • Continuous improvement strategies for cGMP compliance