Fundamentals of Good Manufacturing Practices (GMP) Training by Tonex
This course provides a comprehensive understanding of Good Manufacturing Practices (GMP) for the production of pharmaceuticals, medical devices, and other products. It covers the regulatory requirements, quality management systems, and best practices essential for GMP compliance.
Learning Objectives:
- Understand the principles of Good Manufacturing Practices (GMP).
- Analyze the regulatory framework for GMP.
- Evaluate the roles and responsibilities in a GMP-compliant facility.
- Assess the importance of quality management systems in GMP.
- Explore best practices for manufacturing and documentation.
- Develop strategies for implementing and maintaining GMP standards.
Audience:
- Manufacturing professionals
- Quality assurance specialists
- Regulatory affairs professionals
- Production managers
- Compliance officers
Program Modules:
Module 1: Introduction to Good Manufacturing Practices (GMP)
- Overview of GMP principles
- Historical development of GMP
- Key regulatory requirements (FDA, EMA)
- Role of GMP in product quality and safety
- Case studies of GMP applications
- Future trends in GMP
Module 2: Regulatory Framework for GMP
- Overview of GMP regulations
- Key regulatory bodies (FDA, EMA, WHO)
- Compliance requirements and guidelines
- Regulatory inspections and audits
- Case studies of regulatory compliance
- Future trends in GMP regulation
Module 3: Roles and Responsibilities in a GMP Facility
- Responsibilities of quality assurance (QA) units
- Role of production managers and supervisors
- Duties of manufacturing personnel
- Responsibilities of regulatory affairs professionals
- Case studies of GMP roles
- Collaboration and communication in GMP facilities
Module 4: Quality Management Systems (QMS) in GMP
- Overview of QMS principles
- Developing and maintaining QMS
- Documentation and record-keeping practices
- Quality risk management
- Case studies of QMS implementation
- Best practices for QMS management
Module 5: Manufacturing and Documentation Practices
- Good documentation practices (GDP)
- Standard operating procedures (SOPs)
- Batch records and production documentation
- Equipment qualification and validation
- Case studies of manufacturing practices
- Strategies for ensuring data integrity
Module 6: Implementing and Maintaining GMP Standards
- Developing GMP compliance programs
- Training and education for manufacturing staff
- Monitoring and auditing manufacturing practices
- Risk management and corrective actions
- Case studies of GMP implementation
- Strategies for maintaining GMP compliance