NSF COURSE – New Annex 1: How to develop an effective Contaminantion Control Strategy

Date: 17/09/2019
Venue: Hotel Michelangelo, Milano
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Control Strategies are in increasing demand to support the increasing complexity of pharmaceutical products and interactions among critical quality factors, processes, production environments and patients make the process aiming to grant conformity to the three pillars “quality, effectiveness, patient safety”, in the production of sterile medicines more challenging.


Qualified Person (QP) and other technical staff need to be informed on the requirements in the draft on the new Annex1 and their correct intepretation, because they can have a significant impact both for patient and for company. The Contamination Control Strategy (CCS) defines a documented approach and the arguments cited to control product quality, its effectiveness and patient safety in the production of sterile pharmaceutical products. These requirements can be undermined by contamination of various nature. CCS and risk control measures (technical and organizational) are necessary to help minimizing risks of such an impairment.

What you’ll learn in this  one day course
• Overview of the changes in new Annex1 and their implications
• Detailed guide on methodology, format and contents in preparing CCS
• Regulatory bodies expectations about CCS and how they’ll use it to assess the compliance to cGMP of your sterile structure

• Recent updates on new Annex1 status
• Areas of potential criticalities in the implementation of new Annex1
• Overview of the changes in new Annex1 and necessity of having CCS
• Best practices in the creation of the team and methodology to draft CCS
• Structure, format and use of CCS
• CCS contents: overview of the key aspects ok this document

Why not sharing your problems to discuss them together?
The course is an opportunity to share experiences with solidly skilled tutors and with collegues who have roles similar  to yours. Our courses are planned to keep you informed and to give you answers through discussions and work groups.

Seminar Tutors
We believe that our team of experts is the best available. Not only they have years of experience in the pharmaceutical industry, but they also have committed to lead and support people in improving and raising the standards. We believe that you attend courses to learn the latest news in regulatory affairs.

Hotel Michelangelo – Piazza Luigi di Savoia, 6 – Milano
Metropolitana Linea 2 – 3 (fermata Stazione Centrale)

Registration Fee
● € 665,00 for AFI associates
● € 600,00 for the second AFI associate
● € 770,00 for AFI non associates
● € 640,00 for the second AFI non associate
(solo una quota scontata per ciascun sito)
Nota: Richieste da partecipanti le cui aziende sono basate nei paesi EU non saranno soggette ad IVA, A CONDIZIONE CHE, sia fornita la Partita IVA al momento della prenotazione, altrimenti verrà applicata.

Registration fee include:
● one lunch
● two coffee breaks

Modalità di iscrizione e di pagamento
Registration must be finalised by filling the registration form and sending it via fax by 12 september to New Aurameeting; after receiving confirmation from New Aurameeting, Registration fee will have to be paid by band transfer using the following coordinates:
● NSF Health Sciences Ltd
IBAN: GB61NWBK60720884008636

PAYMENT MUST BE MADE STRICTLY BY 12 SEPTEMBER. New Aurameeting will send the confirmation by mail. Registration will be accepted until seats are available.

For further info, please contact the Organizing Secretariat:
New Aurameeting Srl
Via Rocca d’Anfo, 7 – 20161 Milano
Tel. 0039 02 6620 3390
eventi@newaurameeting.it – www.newaurameeting.it


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