"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"
Contamination Control Strategy
- Get In-depth knowledge about the different potential contaminants in contact with sterile drugs produced in classified areas.
- Master the aseptic practices needed in your own activity
- Perform troubleshooting in order to manage investigations linked to a microbiological issue.
- Manage Trends Analysis of Environmental Monitoring
- Understand the expectations described in Chapter 2 of the new EU Annex 1 draft , published December 2017
Who should attend:
This training is intended for Production Managers, Quality Support Managers, Microbiological Laboratory Managers with a minimum experience of 5 years in pharmaceutical manufacturing.
Course content:Regulatory Point
- European and American Regulations :
- European GMP - “New draft of Annex 1 Manufacture of Sterile Medicinal Products”
- American GMP - FDA “Guidance for Industry Sterile Drug Products Produced by Aseptic processing – Current Good Manufacturing Practice (September 2004)”
- The different contaminants:
- Particles and microorganisms
- The general functions of a classified area :
- HVAC, aeraulic schemes, airlocks,…
- Classification and monitoring of classified areas
- ICH Q9 :
- FMEA Tool
- New draft of Annex 1:
- Expectations for the Contamination Control Strategy
- FMEA Tool used to manage your Contamination Control Strategy :
- The different Failure Mode Effects to take into account
- Example of an approach:
- Feedback on an actual case for a classified area with an aseptic Process
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.
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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.
US and EU
Mr Pierre Devaux
9.00-16.30 (Registration 08.30-09.00)
Register by 24 Oct and save 750 DKK (€ 100)
Until 24 Oct: 7 080 DKK (€ 950)
From 25 Oct: 7 830 DKK (€ 1 050)
incl. course material (pdf), lunch 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 15%
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.