"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.
When attending a Key2Compliance® course, you get access to Gate2GMP®, our document library and search tool.
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.
Watch this short video to learn more about what Gate2GMP® offers »
Bring this course in-house?
Are you a group in need of the same training?
Do you wish to customize this course to suit your needs?
If so, running the course in-house is probably the best and most cost effective solution.
4.1 of 5
"Very experienced trainer and lot on knowledge."
Pharmaceuticals and Medical Devices
US and EU
Mr Frédéric Laban
Date, location and venue:
Prel. November/December 2018
This course is also offered in-house.
Click here for more info and inquiry form.
9.00-16.30 (Registration 08.30-09.00, day 1)
14 400 DKK (€ 1 925) incl. course material (pdf), lunches and refreshments
Note. Due to tax/VAT regulations within the EU (for courses/seminars/conferences), the course fee is invoiced in the local currency and local VAT is added.
Accommodation is NOT included in the course fee.
For groups registered and invoiced together for the same course we offer the following quantity discount:
2-3 persons 10%
4 or more 20%
Quantity disconts can not be combined with other discounts or offers.
We do not offer or practice any general company discounts without commitments and/or written agreements.
This is primarily to protect the environment. Therefore, we encourage you to bring a laptop / tablet to the course - it is possible to make notes in the PDF file you will have access to.
1-2 weeks prior the course you will receive login details to www.Gate2GMP.com where you can download the course handouts as a PDF.
Note pads and pens will always be provided at the venue.
Cancellation of registration:
Registration is binding and when you have received our confirmation the following conditions are known and accepted. If you for any reason is unable to attend, substitution is always possible and preferred.
All cancellations and/or substitutions must have been communicated with and confirmed by us.
Cancellations received less than 30 calendar days before course start are subjected to a service charge of 150 € (Euro)/registered course day as compensation for additional administrative burden and for non refundable part of the conference reservation. Cancellations received less than 7 calendar days prior the course, or failure to cancel or "no-show", will be charged in full.
Cancellation of courses: Courses may be cancelled by the organizer if bookings fail to reach minimum numbers (normally not later than 30 days prior the course start), or due to other reasons beyond our control. In such circumstances charged course fees will be refunded, credited, or granted to attend another course for the same value. NOTE! Key2Compliance AB is NOT responsible or liable to any costs in conjunction with a cancelled course. If you need to book flights way ahead (+35 days prior the course) check with us before finalizing the purchase of flights and/or hotel accommodation for an update on the registration situation.