GAMP Training Program
Pertecnica Engineering offers an in-depth GAMP (Good Automated Manufacturing Practice) Training Program designed to equip professionals with the knowledge and skills needed to implement and manage automated systems in pharmaceutical manufacturing. This program covers best practices, regulatory requirements, and practical approaches for ensuring compliance and quality in automated processes.
Program Overview
Our GAMP Training Program provides a comprehensive understanding of the GAMP guidelines, focusing on the development, validation, and maintenance of automated systems. Participants will learn how to apply GAMP principles to ensure the integrity, reliability, and compliance of automated systems within pharmaceutical and biotechnology environments.
Comprehensive Syllabus
- Introduction to GAMP
- Overview of GAMP guidelines and their importance
- The GAMP lifecycle model and its application
- Regulatory framework and standards (FDA, EMA, ICH)
- GAMP Principles and Best Practices
- Key principles of Good Automated Manufacturing Practice
- Risk-based approach to system validation
- Documentation and traceability requirements
- System Development and Validation
- Phases of system development (Design, Implementation, Testing)
- Validation strategies and protocols
- Change control and configuration management
- GAMP Categories and Classification
- Understanding GAMP categories (Software, Hardware, and Systems)
- Classification of automated systems and components
- Impact of system categories on validation requirements
- Quality Assurance and Compliance
- Best practices for ensuring system quality and compliance
- Auditing and inspection of automated systems
- Handling deviations and non-conformance
- Case Studies and Practical Exercises
- Analysis of real-world GAMP implementation scenarios
- Hands-on practice with GAMP documentation and validation processes
- Problem-solving exercises and lessons learned
- Emerging Trends and Technologies
- Advances in automation technologies and their impact on GAMP
- Integration of digitalization and Industry 4.0 concepts
- Future directions and updates in GAMP guidelines
Training Methodology
- Expert Lectures: Detailed explanations of GAMP principles, guidelines, and practices by experienced instructors.
- Interactive Workshops: Practical sessions focusing on GAMP documentation, validation, and compliance.
- Case Studies: Examination of real-world examples and best practices in GAMP implementation.
- Group Discussions: Collaborative learning and sharing of experiences and insights.
Program Duration and Schedule
The GAMP Training Program is available in both full-time and part-time formats to accommodate professionals’ schedules. The course typically spans [X] weeks, with sessions held [X] times per week.
Who Should Attend?
- Automation and control system engineers
- Quality assurance and validation professionals
- IT and compliance officers in the pharmaceutical industry
- System developers and project managers
Certification
Upon successful completion of the program, participants will receive a certification from Pertecnica Engineering, demonstrating their expertise in GAMP practices and automated system management.
Enroll Now
Enhance your knowledge and skills in Good Automated Manufacturing Practice by enrolling in our GAMP Training Program. For more information on course dates, fees, and registration, please contact us