Fundamentals of cGMP for Managers

Length: 2 Days

This comprehensive training course equips managers with essential knowledge of current Good Manufacturing Practices (cGMP) to ensure regulatory compliance and product quality in pharmaceutical and biotechnology industries.

Learning Objectives:

  • Understand the principles and importance of cGMP in pharmaceutical manufacturing.
  • Learn how to implement and maintain cGMP standards effectively.
  • Identify key regulatory requirements and guidelines governing cGMP.
  • Gain insights into quality control and assurance processes within cGMP framework.
  • Develop strategies for managing compliance issues and inspections.
  • Enhance decision-making skills to support continuous improvement in cGMP compliance.

Audience: This course is designed for managers and supervisors involved in pharmaceutical manufacturing, quality assurance, regulatory affairs, and compliance management.

Course Outline:

Module 1: Introduction to cGMP Principles

  • Basic Principles of cGMP
  • Historical Development of cGMP
  • Importance of cGMP in Pharmaceutical Industry
  • Key Terminologies in cGMP
  • Role of Regulatory Agencies in Enforcing cGMP
  • Global Harmonization Efforts in cGMP Standards

Module 2: Regulatory Requirements and Guidelines

  • Overview of Regulatory Framework
  • Current Regulatory Requirements for cGMP
  • FDA Regulations and Guidance Documents
  • International Standards (ICH, WHO, EMA)
  • Compliance with cGMP Regulations
  • Updates and Trends in Regulatory Landscape

Module 3: Quality Control and Assurance in cGMP

  • Principles of Quality Control and Assurance
  • Analytical Methods and Techniques
  • Documentation and Record Keeping
  • Batch Release and Product Testing
  • Quality Risk Management
  • Deviation Handling and CAPA (Corrective and Preventive Actions)

Module 4: Implementation and Maintenance of cGMP Standards

  • Establishing cGMP Compliant Facilities
  • Equipment Qualification and Calibration
  • Personnel Training and Qualification
  • Validation of Processes and Systems
  • Change Control Management
  • Internal and External Audits

Module 5: Managing Compliance Issues and Inspections

  • Common Compliance Issues in cGMP
  • Handling Non-Conformances and Recalls
  • Responding to Regulatory Inspections
  • Preparing for FDA and International Audits
  • Corrective Action Planning
  • Case Studies and Best Practices

Module 6: Continuous Improvement in cGMP Compliance

  • Importance of Continuous Improvement
  • Implementing a Culture of Compliance
  • Monitoring and Metrics for cGMP Compliance
  • Periodic Review and Evaluation Processes
  • Incorporating Feedback and Lessons Learned
  • Future Trends and Innovations in cGMP Compliance