CGMP: A Complete Guide
Course Overview This comprehensive course provides an in-depth understanding of Current Good Manufacturing Practices (CGMP) for the pharmaceutical, biotechnology, and medical device industries. Participants will learn the fundamental principles and regulations of CGMP, as well as practical applications and real-world examples.
Course Objectives - Understand the history and evolution of CGMP
- Learn the key principles and regulations of CGMP
- Apply CGMP principles to real-world scenarios
- Develop a comprehensive understanding of CGMP requirements for pharmaceutical, biotechnology, and medical device industries
- Prepare for CGMP audits and inspections
Course Outline Module 1: Introduction to CGMP
- Definition and history of CGMP
- Evolution of CGMP regulations
- Importance of CGMP in the pharmaceutical, biotechnology, and medical device industries
Module 2: CGMP Principles and Regulations
- Overview of CGMP principles
- 21 CFR Part 211: Pharmaceutical CGMP
- 21 CFR Part 820: Medical Device CGMP
- ICH Q7: Good Manufacturing Practice for Active Pharmaceutical Ingredients
Module 3: Quality Management Systems
- Overview of quality management systems
- ISO 9001: Quality Management System Standard
- ISO 13485: Medical Device Quality Management System Standard
- Quality policy and objectives
- Quality planning and control
Module 4: Personnel and Training
- Personnel requirements for CGMP
- Training requirements for CGMP
- Personnel qualifications and responsibilities
- Training programs and records
Module 5: Facilities and Equipment
- Facility requirements for CGMP
- Equipment requirements for CGMP
- Facility design and layout
- Equipment installation and qualification
- Maintenance and repair of equipment
Module 6: Materials and Supplies
- Material requirements for CGMP
- Supply chain management
- Material specifications and testing
- Material storage and handling
Module 7: Production and Process Controls
- Production and process control requirements for CGMP
- Batch production and control records
- Process validation and verification
- Production and process control procedures
Module 8: Packaging and Labeling
- Packaging and labeling requirements for CGMP
- Packaging and labeling design and control
- Packaging and labeling procedures
- Packaging and labeling records
Module 9: Testing and Release
- Testing and release requirements for CGMP
- Testing and release procedures
- Testing and release records
- Stability testing and shelf-life determination
Module 10: Complaint Handling and Corrective Action
- Complaint handling requirements for CGMP
- Corrective action requirements for CGMP
- Complaint handling procedures
- Corrective action procedures
- Complaint handling and corrective action records
Module 11: Audits and Inspections
- Audit and inspection requirements for CGMP
- Audit and inspection procedures
- Audit and inspection records
- Preparation for audits and inspections
Course Features - Interactive and Engaging: The course includes interactive elements, such as quizzes, games, and discussions, to keep participants engaged and motivated.
- Comprehensive: The course covers all aspects of CGMP, including principles, regulations, and practical applications.
- Personalized: Participants can learn at their own pace and focus on areas of interest or need.
- Up-to-date: The course is regularly updated to reflect changes in regulations and industry practices.
- Practical: The course includes real-world examples and case studies to illustrate key concepts and principles.
- High-quality content: The course is developed by expert instructors with extensive experience in CGMP.
- Certification: Participants receive a certificate upon completion of the course, issued by The Art of Service.
- Flexible learning: Participants can access the course from anywhere, at any time, using a computer or mobile device.
- User-friendly: The course is easy to navigate and use, with clear instructions and minimal technical requirements.
- Mobile-accessible: The course is optimized for mobile devices, allowing participants to learn on-the-go.
- Community-driven: Participants can connect with others in the course community to share ideas, ask questions, and learn from each other.
- Actionable insights: The course provides actionable insights and practical advice that participants can apply in their own work.
- Hands-on projects: The course includes hands-on projects and activities to help participants apply key concepts and principles.
- Bite-sized lessons: The course is divided into bite-sized lessons, making it easy to fit learning into a busy schedule.
- Lifetime access: Participants have lifetime access to the course, allowing them to review and refresh their knowledge at any time.
- Gamification: The course includes gamification elements, such as points and badges, to make learning fun and engaging.
- Progress tracking: Participants can track their progress through the course, setting goals and achieving milestones.
,
- Understand the history and evolution of CGMP
- Learn the key principles and regulations of CGMP
- Apply CGMP principles to real-world scenarios
- Develop a comprehensive understanding of CGMP requirements for pharmaceutical, biotechnology, and medical device industries
- Prepare for CGMP audits and inspections
Course Outline Module 1: Introduction to CGMP
- Definition and history of CGMP
- Evolution of CGMP regulations
- Importance of CGMP in the pharmaceutical, biotechnology, and medical device industries
Module 2: CGMP Principles and Regulations
- Overview of CGMP principles
- 21 CFR Part 211: Pharmaceutical CGMP
- 21 CFR Part 820: Medical Device CGMP
- ICH Q7: Good Manufacturing Practice for Active Pharmaceutical Ingredients
Module 3: Quality Management Systems
- Overview of quality management systems
- ISO 9001: Quality Management System Standard
- ISO 13485: Medical Device Quality Management System Standard
- Quality policy and objectives
- Quality planning and control
Module 4: Personnel and Training
- Personnel requirements for CGMP
- Training requirements for CGMP
- Personnel qualifications and responsibilities
- Training programs and records
Module 5: Facilities and Equipment
- Facility requirements for CGMP
- Equipment requirements for CGMP
- Facility design and layout
- Equipment installation and qualification
- Maintenance and repair of equipment
Module 6: Materials and Supplies
- Material requirements for CGMP
- Supply chain management
- Material specifications and testing
- Material storage and handling
Module 7: Production and Process Controls
- Production and process control requirements for CGMP
- Batch production and control records
- Process validation and verification
- Production and process control procedures
Module 8: Packaging and Labeling
- Packaging and labeling requirements for CGMP
- Packaging and labeling design and control
- Packaging and labeling procedures
- Packaging and labeling records
Module 9: Testing and Release
- Testing and release requirements for CGMP
- Testing and release procedures
- Testing and release records
- Stability testing and shelf-life determination
Module 10: Complaint Handling and Corrective Action
- Complaint handling requirements for CGMP
- Corrective action requirements for CGMP
- Complaint handling procedures
- Corrective action procedures
- Complaint handling and corrective action records
Module 11: Audits and Inspections
- Audit and inspection requirements for CGMP
- Audit and inspection procedures
- Audit and inspection records
- Preparation for audits and inspections
Course Features - Interactive and Engaging: The course includes interactive elements, such as quizzes, games, and discussions, to keep participants engaged and motivated.
- Comprehensive: The course covers all aspects of CGMP, including principles, regulations, and practical applications.
- Personalized: Participants can learn at their own pace and focus on areas of interest or need.
- Up-to-date: The course is regularly updated to reflect changes in regulations and industry practices.
- Practical: The course includes real-world examples and case studies to illustrate key concepts and principles.
- High-quality content: The course is developed by expert instructors with extensive experience in CGMP.
- Certification: Participants receive a certificate upon completion of the course, issued by The Art of Service.
- Flexible learning: Participants can access the course from anywhere, at any time, using a computer or mobile device.
- User-friendly: The course is easy to navigate and use, with clear instructions and minimal technical requirements.
- Mobile-accessible: The course is optimized for mobile devices, allowing participants to learn on-the-go.
- Community-driven: Participants can connect with others in the course community to share ideas, ask questions, and learn from each other.
- Actionable insights: The course provides actionable insights and practical advice that participants can apply in their own work.
- Hands-on projects: The course includes hands-on projects and activities to help participants apply key concepts and principles.
- Bite-sized lessons: The course is divided into bite-sized lessons, making it easy to fit learning into a busy schedule.
- Lifetime access: Participants have lifetime access to the course, allowing them to review and refresh their knowledge at any time.
- Gamification: The course includes gamification elements, such as points and badges, to make learning fun and engaging.
- Progress tracking: Participants can track their progress through the course, setting goals and achieving milestones.
,
- Interactive and Engaging: The course includes interactive elements, such as quizzes, games, and discussions, to keep participants engaged and motivated.
- Comprehensive: The course covers all aspects of CGMP, including principles, regulations, and practical applications.
- Personalized: Participants can learn at their own pace and focus on areas of interest or need.
- Up-to-date: The course is regularly updated to reflect changes in regulations and industry practices.
- Practical: The course includes real-world examples and case studies to illustrate key concepts and principles.
- High-quality content: The course is developed by expert instructors with extensive experience in CGMP.
- Certification: Participants receive a certificate upon completion of the course, issued by The Art of Service.
- Flexible learning: Participants can access the course from anywhere, at any time, using a computer or mobile device.
- User-friendly: The course is easy to navigate and use, with clear instructions and minimal technical requirements.
- Mobile-accessible: The course is optimized for mobile devices, allowing participants to learn on-the-go.
- Community-driven: Participants can connect with others in the course community to share ideas, ask questions, and learn from each other.
- Actionable insights: The course provides actionable insights and practical advice that participants can apply in their own work.
- Hands-on projects: The course includes hands-on projects and activities to help participants apply key concepts and principles.
- Bite-sized lessons: The course is divided into bite-sized lessons, making it easy to fit learning into a busy schedule.
- Lifetime access: Participants have lifetime access to the course, allowing them to review and refresh their knowledge at any time.
- Gamification: The course includes gamification elements, such as points and badges, to make learning fun and engaging.
- Progress tracking: Participants can track their progress through the course, setting goals and achieving milestones.