Workshop on cGMP Compliance Through Regular Inspections and Audits of Manufacturing Facilities

Length: 2 Days

This intensive workshop is designed to provide comprehensive training on achieving and maintaining cGMP (Current Good Manufacturing Practices) compliance through effective regular inspections and audits of manufacturing facilities. Participants will learn the intricacies of preparing for FDA inspections, understanding regulatory requirements, and implementing best practices in manufacturing processes to ensure continuous compliance with cGMP standards.

Learning Objectives:

Upon completion of this workshop, participants will be able to:

  • Understand the key elements of cGMP regulations and their application in manufacturing.
  • Prepare effectively for FDA and other regulatory inspections.
  • Conduct internal audits to assess and improve cGMP compliance.
  • Identify common areas of non-compliance and implement corrective actions.
  • Develop and maintain a quality management system that meets cGMP standards.
  • Navigate the regulatory environment and respond appropriately to inspection findings.

Target Audience:

  • Quality Assurance and Quality Control Managers
  • Compliance Officers
  • Manufacturing and Production Supervisors
  • Regulatory Affairs Professionals
  • Facility and Operations Managers
  • Any professional involved in the pharmaceutical, biotechnology, and medical device manufacturing sectors.

Course Modules:

Module 1: Introduction to cGMP

  • Overview of cGMP principles and requirements
  • Historical background and importance of cGMP in manufacturing

Module 2: Regulatory Framework and Compliance

  • Understanding the role of the FDA and other regulatory bodies
  • Navigating the regulatory landscape and staying updated with changes

Module 3: Preparing for Regulatory Inspections

  • Steps to ensure readiness for an FDA inspection
  • Best practices for hosting regulatory inspections

Module 4: Conducting Internal Audits

  • Designing and implementing an effective internal audit program
  • Training internal auditors and conducting mock inspections

Module 5: Managing Compliance and Quality Systems

  • Establishing and maintaining a quality management system (QMS)
  • Documentation, record-keeping, and data integrity in cGMP compliance

Module 6: Identifying and Addressing Non-Compliance

  • Common areas of non-compliance and how to avoid them
  • Developing and implementing corrective and preventive actions (CAPA)

Module 7: Post-Inspection Activities

  • Responding to inspection findings and formulating responses
  • Implementing continuous improvement practices to ensure ongoing compliance

Module 8: Case Studies and Real-World Scenarios

  • Analyzing real-world examples of cGMP inspections and audits
  • Group discussions and problem-solving exercises

Course Delivery

  • Format: In-person, interactive sessions with practical exercises, case studies, and group discussions.
  • Materials: Comprehensive course manual, checklists, and templates for preparing for inspections and audits.