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Compliance Seminars®

Understanding the new draft of

EU Annex 1 - Manufacture of Sterile Medicinal Products

 

New draft released February 2020

The new version of Annex 1 has major updates, in both structure and content.
This session guides you through the changes, point by point.

 

This interactive training will be supported by many examples and group discussions around Sterile manufacturing issues.
The new draft of EMA Annex 1 of Eudralex vol. 4 will be will be accurately reviewed and each new expectation will be deciphered and analyzed to be translated into operational terms .


Objectives

The main objective of this session is to have an exhaustive overview and comprehension of the new draft of the Annex 1 published on February 2020.

Who should attend:

This training is intended for personnel categories such as Quality Assurance, Sterility Assurance, Production, Facilities, Engineering, Auditors, Qualified Persons and all support functions involved in contamination in sterile environments.

Course content:

  • Scope and Principle: Reinforcement of the specific terminology CCS (Contamination Control Strategy)
  • Pharmaceutical Quality System (PQS) and requirement for an effective risk management system integrated into the product life cycle
  • Premises: Focus on Barrier Technologies Systems (Isolators and RABS) – Cleanroom and clean air equipment qualification – Disinfection
  • Equipment
  • Utilities: Focus on Water Systems
  • Personnel: Focus on the Qualification of the personnel
  • Production and Specific Technologies: For this section, the speakers will be able to adapt their speaking to answer to the specific cases of all the participants.
  • Viable and non-viable environmental and process monitoring: Particular Focus on Aseptic Process Simulation
  • Quality control (QC)

The course will be illustrated from specific situations met by the speakers in Pharmaceutical companies.

 

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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.

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Course facts

Course no:
5230
Industry:
Pharmaceuticals

Level:
Intermediate
GMP region:
EU

Language:
English

Instructors:
Pierre Devaux  Emmanuel Gourvil
Pierre Devaux and Emmanuel Gourvil, Theraxel - Point Forty Five

Date, location and venue:

3-4 December, Amsterdam
Double Tree Hilton, Centraal Station
Oosterdoksstraat 4    

Register by 22 October - Save € 200

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


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

Price (excl. local VAT):
Register by 22 Oct - Save € 200
Until 22 Oct: € 1 850
From 23 Oct: € 2 050
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.