"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"
Contamination control in cleanrooms for Life Science production
- State-of-the-art for cGMPs and industry practice
(aseptic and non aseptic operations)
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.
Who should attend:
This training is intended for personnel categories such as Quality Assurance, production, facilities, engineering, auditors, and all support functions involved in contamination controlled environments.
- Review of cGMP's in US and EU, in particular on clean and sterile operations
- Recent FDA 483's and "Warning Letters", current expectations of the authorities
- Contamination and cross contamination, definitions
- The sources and vectors of contamination
- Comprehensive approach activities against contamination
- Cleanroom technology and controlled zones
- The ISO cleanroom classes (US FS 209), GMP requirements in US and EU
- Particulate and microbiological environmental monitoring
- Material and personnel flow
- Gowning and accessories
- Hygiene and behavior, dressing
- Personnel monitoring and microbiology
- Aseptic techniques
- Personnel qualifications
- Cleaning and disinfection
- Summary and conclusions
At the end of this session the participants will have a full understanding of US and EU GMP references. Participants will have the knowledge necessary for a comprehensive approach to contamination control in the cleanroom, from design to operation. They will learn about the consistency of control methods to be implemented. They have acquired tools for auditing flows, and clean and aseptic operations.
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At Gate2GMP® each course has its own page where you can download course materials, receive up to date information and communicate in the course forum.
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"Very experienced trainer with lot of knowledge."
Pharmaceuticals and Medical Devices
US and EU
Mr Pierre Devaux
Date, location and venue:
This course is only offered in-house.
Click here for more info and inquiry form.