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Compliance Seminars®

Contamination Control Strategy

- An essential requirement of the Annex 1


Course objectives

  • Understanding of the expectations described in the new draft of the Annex 1 published on February 2020
  • Deepen the knowledg about the different potential contaminants in contact with the sterile drugs produced in your classified areas.
  • Master the aseptic practices needed in your own activity
  • Ability to make troubleshooting in order to manage investigation linked to a microbiological issue.
  • Ability to manage Trends Analysis of Environmental Monitoring

Who should attend:

This training is intended for Production Managers, Quality Support Managers, Microbiological Laboratory Managers, Sterility Assurance Managers and Qualified Persons with a minimum experience of 5 years in the life science industry.

Course content:

Regulatory Point
  • European and American Regulations:
    • European GMP - “New draft of Annex 1 Manufacture of Sterile Medicinal Products (February 2020)”
    • 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 in a classified area:
    • HVAC, aeraulic schemes, airlocks,…
  • Classification and monitoring of classified areas
  • New draft of Annex 1:
    • Expectations for the Contamination Control Strategy
  • ICH Q9 :
    • FMEA Tool
  • FMEA Tool used to manage your Contamination Control Strategy :
    • The different Failure Mode Effects to take into account
  • Example of an approach:
    • Feedback on a concrete case for a production area

 

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Course facts

Course no:
5124
Industry:
Pharmaceuticals

Level:
Intermediate
GMP region:
US and EU

Language:
English

Instructors:
  Elodie Pastre
Pierre Devaux et Elodie Pastre, Theraxel - Point Forty Five

Date, location and venue:

2 December, Amsterdam
Double Tree Hilton, Centraal Station
Oosterdoksstraat 4    

Register by 21 October - Save € 100

This course is offered in-house.
Click here for more info and inquiry form.


Time:
1 day
9.00-16.30 (Registration 08.30-09.00)

Price (excl. local VAT):
Register by 21 October and save € 100
Until 21 Oct: € 950
From 22 Oct: € 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.

Discounts:
For groups registered and invoiced together for the same course we offer the following quantity discount:
3 persons or more 15%
We do not offer or practice any general company discounts without commitments and/or written agreements.


Course material (Handouts)  
No printed course material will be provided on our courses*.
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.
3-5 days prior the course you will receive a download link for the course handouts as a PDF.
Note pads and pens will always be provided at the venue.

Cancellation policy - Compliance Seminars®  

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 14 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.