Why this topic?
Production systems for the pharmaceutical and food industries have to comply with ever-stricter legislation. Every company that makes products for the European or American market is subject to the laws of the EMA (European Medicine Agency), FDA (Food & Drug Administration) and/or FAMHP (Federal Agency for Medicines and Health Products). These include GMP (Good Manufacturing Practices, also known as Predicate Rules) including EU GMP Annex 1, 21CFR Part 11 and/or Annex 11.
However, GAMP ® (ISPE) (Good Automated Manufacturing Practice) is not legislation, but a practical interpretation of this legislation and can be regarded as a structured and project-based approach for the validation of (automation) systems. In fact, this approach includes various working methods that could generally be considered good practice. The validation and use of electronic data and signatures is defined in the 21CFR Part 11 legislation. It sets out rules with which a system must comply so that electronic data and signatures can be regarded as the equivalent of their paper counterparts. Annex 11 is the recommendation of the EMA on how IT systems should be handled. Annex 11 can be seen as the foundation on which GAMP 5 can be built.
What can you expect during the training?
- You will acquire an insight into the requirements, expectations and responsibilities when validating automated systems
- You will get insight into the structure and use of the V model when implementing systems. You will be given a practical translation of the GMP guidelines, as these appear in GAMP 5, with a focus on the differences compared to GAMP 4
- You will receive a practical interpretation of the 21CFR Part 11 law on the use of electronic data and signatures within a regulated environment. You will be given an overview of what precisely is expected of IT systems from the perspective of Annex 11 (both in terms of implementation and the management of these validated systems)
- We focus on both implementing systems in a controlled environment and on maintaining control of systems during their life cycle
This training is intended for anyone involved in the development/implementation of automated production systems for the pharmaceutical sector, the cosmetics industry, the food industry or related sectors where quality is an important factor.
- FDA, EMA and regulations
- Workflow of automation systems: V model
- Differences compared to GAMP 4
- Design and validation
- Risk-Based approach: theory and practice
- Commissioning & qualification
- Tasks and responsibilities
- Maintenance of validated systems
21CFR Part 11
- Electronic records
- Electronic signatures
- Audit trail
- Practical interpretation
- Risk management
- What requirements are placed on staff?
- How to deal with suppliers and subcontractors?
- What tasks are expected in the various project phases?