"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"
Cleaning and decontamination of surfaces in classified areas and equipment
- Get a better understanding of the GMP context to clean premises and non critical surfaces in classified areas and equipment.
- Master the choice of methods to put in place and adapt them to GMP requirements.
- Design a Biocleaning program adapted to premises and its activities.
- Provide innovative measures to introduce practical methods.
Who should attend:
This training is intended for managers and personnel in charge of biocleaning operations, Quality Support Managers and Production Managers.
- European and American Regulations:
- “Part I Chapter 3 – Premise and Equipment”
- “Part I Chapter 5 - Production”
- “Annex 1 Manufacture of Sterile Medicinal Products”,
- FDA “Guidance for Industry Sterile Drug Products Produced by Aseptic processing – Current Good Manufacturing Practice (September 2004)”
- PDA “Technical Report No.70 Fundamentals of cleaning and Disinfection Programs for Aseptic Manufacturing Facilities”
- Contaminants to bioclean:
- Particles, Microorganisms, Chemical residuals of ancillary products (detergents, disinfectants, …).
- The different steps of a Biocleaning program:
- Disposal of visible waste
- Dusting (wet sweeping and wet wiping)
- Disposal of soiled solution
- Good practices of Biocleaning:
- Feedback on actual cases
- Characteristics of different biocleaning tools and storage conditions in production:
- Vacuum cleaners, wipes, brooms,…
- Quality Assurance and Biocleaning:
- The different documents needed and example of an audit tool
- Disinfection by air:
- Hydrogen peroxide vapor techniques
- Biocleaning Practices after a shutdown
- Validation of the effectiveness of a Biocleaning Process:
- Specific Environmental Monitoring
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.
US and EU
Mr Pierre Devaux
Date, location and venue:
May 16, 2019, Copenhagen Denmark
(Entrance from Kvægtorvsgade)
This course is also offered in-house.
Click here for more info and inquiry form.
9.00-16.30 (Registration 08.30-09.00)
Register by 4 Apr and save 750 DKK (€ 100)
Until 4 Apr: 7 080 DKK (€ 950)
From 5 Apr: 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 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.