"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"

Compliance Seminars®

Understanding the new draft of

EU Annex 1 - Manufacture of Sterile Medicinal Products



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 .


The main objective of this session is to have an exhaustive overview and comprehension of the 2018 draft of Annex 1

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 in sterile environments.

Course content:

  • Principle now with references to other GMPs texts
  • Pharmaceutical Quality System (PQS) and requirement for an effective risk management system integrated into the product life cycle
  • Personnel: new expectations on qualification - hygiene - clothing - monitoring
  • Premises: with special points on air locks - RABs and environmental qualification for viables and non viables
  • Equipments: with new requirements on design, maintenance and repairs, cleaning and specific durations
  • Utilities
  • Production and specific technologies
  • Viable and non-viable environmental and process monitoring, with recommended limits; new reference to rapid microbial monitoring methods; and new Aseptic Process simulation approach
  • Quality control (QC): APS



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.

Make an enquiry




Course facts

Course no:

GMP region:


Mr Pierre Devaux

Date, location and venue:

3-4 December 2019, Copenhagen, Denmark
Tietgensgade 65    
(Entrance from Kvægtorvsgade)

Register by 22 Oct - Save 1 500 DKK (€ 200)

Specify our booking code D000030870 to get a discount when making a reservation at a Scandic Hotel.
Scandic Hotels nearby:
» Scandic Webers (500m)
» Scandic Kødbyen (800m)
» Scandic Copenhagen (800m)

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

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

Price (excl. local VAT):
Register by 22 Oct - Save 1 500 DKK (€ 200)
Until 22 Oct: 13 780 DKK (€ 1 850)
From 23 Oct: 15 280 DKK (€ 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.

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.

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.
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 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 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.