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The new Annex 1 of EU GMP
– interpretations and applications,
how to comply?

(Manufacture of Sterile Medicinal Products)

 

Industry field:

Pharmaceutical industry, Quality Assurance

 

Course description:

This constantly updated course, integrates the most recent EMEA, and PICs intentions and recommendations including the key points used for the training of European inspectorates and PDA remarks. If you don’t feel comfortable with the interpretations and the way to implement this new GMP requirements; come and join our interactive one day course on this hot topic.

 

Objectives and content:

This course is aimed at production and quality personnel involved in GMP regulated aseptic manufacturing.

 

We offer a one-day interactive course around the updated Annex 1 of the EU GMP. During this day we will compare the previous version with the new one, and differences and news will be highlighted. Parallels with the draft aseptic manufacturing guideline from the FDA 2004 will also be covered.


The new key points such as cleanroom classification, validation of aseptic processes (Media Fill Test), bioburden monitoring, and new requirements for capping processes will be particularly developed with the concern to be reasonable, achievable and practical.


The day, based on interactions between the participants and the lecturer, will be alternating group exercises with formal presentations. A normative and technical documentation will complete the day.

 

Learning objectives:

Following this course, participants will experience all changes and evolutions of the last version of Annex 1, as well as developing know how to interpret, comply and implement these new requirements into operational terms.

 

» Registration

» Download course folder (PDF)

» Registration

» Download course folder (PDF)

 

Course facts

Course No:

5108
Instructors:

Mr Frédéric Laban
Next course:

March 25, Malmö, Sweden
May 21 Stockholm, Sweden
Course venue:

» S:t Gertrud Conference, Malmö

» Nordic Sea Hotel, Stockholm
Agenda:

10.00-16.30

(Registration 09.30-10.00)
Price:

€ 495 incl. course material, lunch and refreshments
Discounts:

We do not offer any general discounts. Instead we will always offer best value courses for good value fees to ALL our attendees. For larger groups we can offer discounts based on case by case discussions, please contact for quotation. We do not offer or practise any general company discounts without commitments and/or written agreements.
Cancellation policy:

Registration is binding. If for any reason a registered participant is unable to attend, substitution is always possible and preferred. All cancellations must be in writing (letter, fax or e-mail). Cancellations received less than 21 calendar days before course start are subjected to a service charge of 200 € + 100 €/course day (Euro). No refunds or credits are issued for failure to cancel or "no show". Courses may be cancelled by the organiser if bookings fail to reach minimum numbers. In such circumstances course fees will be refunded.