Every company manufacturing products for the American market is subject to the laws of the FDA (Food & Drug Administration). These include GMP (Good Manufacturing Practices, also known as Predicate Rules) and 21 CFR Part 11. The GAMP course, or Good Automated Manufacturing Practices, helps you with the practical interpretation of these U.S. regulations.
- Understand the requirements, expectations, and responsibilities for validating automated systems
- Learn to implement systems in a controlled environment and maintain validated systems throughout their lifecycle
- Gain insight into the structure and use of the V-model during system implementation
Validating automation systems according to Good Automated Manufacturing Practices (GAMP)
How do you ensure quality in the implementation and management of automated systems? The GAMP training focuses on a structured and project-based approach for validating (automation) systems. You will also learn how to validate and use electronic records and signatures as defined in the legislation 21CFR Part 11. Production systems for the pharmaceutical and food industries must comply with increasingly stringent laws. The training provides practical examples and templates that you can apply within your own organization.
Program
Introduction
- Food and Drug Administration (FDA), European Medicines Agency (EMA), and regulations
- International Society for Pharmaceutical Engineering (ISPE)
GAMP5
- Approach for structured automation projects: V-model
- Differences from GAMP4
- Project phasing
- Design and validation
- Risk-based approach: theory and practice
- Commissioning and qualification
- Roles and responsibilities
- Maintenance of validated systems
Code of Federal Regulations (21CFR Part 11)
- Electronic documents
- Electronic signatures
- Audits
- Practical interpretation
Discover the possibilities to organize this course incompany
If you want to train several employees in your company, it is more interesting and cheaper to organize a course at your location. Good coordination with your company-specific situation and the deployment of highly experienced lecturers who have earned their spurs in practice is essential here. Mikrocentrum is CEDEO-recognized and guarantees the best quality.
Our training manager is happy to think along with you!
Are you interested in an incompany process? Our training manager Barend Blom will be happy to visit you without obligation.