Advanced cGMP Training

Length: 2 Days

This Advanced cGMP Training Course by Tonex provides comprehensive insights into current Good Manufacturing Practices (cGMP) regulations, emphasizing advanced techniques and compliance strategies. Participants will delve into complex regulatory requirements and explore advanced methodologies for ensuring quality and compliance in pharmaceutical manufacturing.

Learning Objectives:

  • Understand advanced cGMP concepts and regulations.
  • Implement advanced quality control and assurance techniques.
  • Explore cutting-edge methodologies for cGMP compliance.
  • Enhance problem-solving skills related to cGMP challenges.
  • Apply risk-based approaches to cGMP compliance.
  • Strengthen audit readiness and regulatory inspection preparedness.

Audience: Professionals in pharmaceutical manufacturing, quality assurance, regulatory affairs, and compliance seeking advanced knowledge and skills in cGMP.

Course Outline:

Module 1: Advanced cGMP Regulations Overview

  • Evolution of cGMP Regulations
  • International Harmonization Efforts
  • Emerging Trends in cGMP Compliance
  • Advanced Interpretation of Regulatory Guidance
  • Regulatory Updates and Implications
  • Case Studies on Regulatory Compliance Challenges

Module 2: Advanced Quality Control and Assurance Techniques

  • Advanced Statistical Process Control (SPC) Methods
  • Application of Six Sigma in Pharmaceutical Manufacturing
  • Advanced Analytical Techniques for Quality Assurance
  • Risk-based Sampling and Testing Strategies
  • Quality by Design (QbD) Implementation in cGMP
  • Advanced Process Validation Techniques

Module 3: Cutting-edge Methodologies for cGMP Compliance

  • Advanced Cleanroom Design and Operation
  • Use of Automation and Robotics in Manufacturing
  • Advanced Data Integrity Practices
  • Implementing Continuous Manufacturing Processes
  • Advanced Environmental Monitoring Techniques
  • Technology Transfer Best Practices

Module 4: Problem-solving Strategies for cGMP Challenges

  • Root Cause Analysis in cGMP Deviations
  • Advanced Corrective and Preventive Action (CAPA) Strategies
  • Managing Out-of-Specification (OOS) Results
  • Addressing Compliance Issues in Supply Chain Management
  • Advanced Change Control Procedures
  • Case Studies on Problem-solving in cGMP Compliance

Module 5: Risk-based Approaches to cGMP Compliance

  • Risk Assessment Methodologies in cGMP
  • Implementing Risk-based Cleaning Validation
  • Risk-based Supplier Qualification and Management
  • Advanced Risk Mitigation Strategies
  • Incorporating Risk Management into Process Validation
  • Case Studies on Risk-based Approaches in cGMP Compliance

Module 6: Audit Readiness and Regulatory Inspection Preparedness

  • Developing Effective Internal Audit Programs
  • Mock Audit Exercises and Preparation
  • Advanced Documentation Practices for Audit Trails
  • Handling Regulatory Inspections with Confidence
  • Addressing FDA 483 Observations and Warning Letters
  • Continuous Improvement Strategies for Audit Readiness