Advanced Quality Systems and cGMP

Length: 2 Days

This comprehensive training course delves into the intricacies of advanced quality systems and current Good Manufacturing Practices (cGMP). Participants will gain a deep understanding of the regulatory requirements, quality management principles, and advanced methodologies necessary for ensuring compliance and optimizing quality in pharmaceutical and biopharmaceutical manufacturing.

Learning Objectives:

  • Understand advanced concepts and principles of quality management systems (QMS).
  • Gain insight into the latest regulatory guidelines and requirements for cGMP compliance.
  • Learn advanced methodologies for quality risk management and mitigation.
  • Develop skills in implementing effective corrective and preventive actions (CAPA).
  • Explore strategies for continuous improvement in quality systems.
  • Acquire knowledge of auditing techniques for assessing and maintaining cGMP compliance.

Audience: Professionals working in pharmaceutical and biopharmaceutical industries involved in quality assurance, quality control, regulatory affairs, compliance, manufacturing, and operations.

Course Outline:

Module 1: Overview of Advanced Quality Systems and cGMP

  • Evolution of Quality Systems
  • Importance of cGMP in Pharmaceuticals
  • Key Principles of Quality Management
  • Integration of Quality Systems
  • Role of Regulatory Agencies
  • Emerging Trends in Quality Assurance

Module 2: Regulatory Requirements and Guidelines for cGMP Compliance

  • FDA Regulations and Guidance Documents
  • International Regulatory Frameworks (ICH, EMA, etc.)
  • Compliance Requirements for Manufacturing Facilities
  • Documentation and Recordkeeping Practices
  • Validation and Qualification Procedures
  • Regulatory Inspections and Audits

Module 3: Advanced Quality Management Principles and Practices

  • Quality by Design (QbD) Approach
  • Process Analytical Technology (PAT)
  • Statistical Process Control (SPC) Methods
  • Failure Mode and Effects Analysis (FMEA)
  • Six Sigma Methodologies
  • Lean Manufacturing Principles

Module 4: Quality Risk Management and Mitigation Strategies

  • Risk Assessment Techniques
  • Risk Control and Mitigation Plans
  • Application of Risk-Based Decision Making
  • Change Management Processes
  • Supplier Quality Management
  • Continual Improvement Strategies

Module 5: Corrective and Preventive Action (CAPA) Implementation

  • Understanding CAPA Concepts
  • Root Cause Analysis (RCA) Methods
  • Developing CAPA Plans
  • Implementation and Verification Processes
  • Effectiveness Monitoring and Review
  • CAPA Documentation and Reporting

Module 6: Auditing Techniques for Assessing cGMP Compliance

  • Audit Planning and Preparation
  • Conducting Internal Audits
  • Supplier and Third-Party Audits
  • Audit Reporting and Follow-Up Actions
  • Regulatory Inspection Readiness
  • Continuous Improvement in Audit Processes