Advanced Quality Systems and cGMP Certification Course by Tonex
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