This training covers the necessary requirements (regulatory and technical) to control contamination in production or research operations in cleanrooms, in accordance with the requirements of the FDA and the EMA.
The means of contamination and cross contamination control are discussed in detail (cleanrooms, micro-environments, zone, flows, cleaning, hygiene and behavior, …). For each operation (aseptic, dry forms, terminal sterilization, etc..), requirements and expectations of US and EU authorities are systematically compared to the techniques available, and then compared and translated into practical recommendations. The application exercises allows the participants to apply the recommendations of the course instructor to real life.
The main objective of this session is to have an exhaustive overview of the contamination control management in a pharmaceutical plant.
This training is intended for personnel categories such as Quality Assurance, production, facilities, engineering, auditors, and all support functions involved in contamination controlled environments.
This course is available as an In-House Training course. Let us know if you wish to customize a course or if you are a large group with the same requirements.
Leading specialist with long experience of training are guiding you through regulations, guidelines, interpretations, requirements and applications.
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