MICROBIOLOGY DAYS

ANNEX 1 REVISION: QRM & INNOVATION TECHNOLOGY

How to enhance the overall Sterility Assurance Process

 

November 14-15, 2018 |   Milan (Italy)


11th Edition - Main Topics

The XI edition of the Microbiology Days organized by PEC - Pharma Education Center will focus on the following aspects:

  • INSPECTION TRENDS
  • ANNEX 1 REVISION - PRODUCT/PACKAGE
  • QUALITY: UPDATES BY PDA WORKGROUP
  • ENVIRONMENTAL MONITORING
  • APS - PUPSIT-CLEANING
  • CONTAINMENT SYSTEMS & CONTAMINATION
  • CONTROL STRATEGY

In addition to this, Dr. Fernanda Ferrazin, Former GMP Senior Inspector at AIFA (Italian Medicines Agency) and  Indipendent Pharmaceutical Consultant will moderate the 2 days Conference dedicated to the  latest Annex 1 Revision, particularly QRM & Innovation Technology and how to  enhance the overall Sterility Assurance Process.

 

Speakers panel will be enriched by institutional experts as well as  renomated international  professionals.

Full program and agenda available here:

 

 

Download
Final_GIMI_2018_1-compressed.pdf
Documento Adobe Acrobat 845.9 KB

Book your place with a discount of €200 for 2 days of full immersion with a panel of authoritative speakers, discussion spaces and round table - registrations by September 15, 2018!

For enrollments, email


About XI Microbiology Days

PEC - Pharma Education Center S.r.l. invites professionals from pharmaceutical companies to participate in the 11th MICROBIOLOGY DAYS which will be held in Milan (ITALY) next November 14th and 15th, 2018.

 

The revision of the Annex 1 has concluded the step of collection of comments on March 20th, 2018 and evaluation of the final issues is now underway.

As a matter of fact, the draft contents  has already indicated a way for important changes for sterile processes, with potential impacts on investments and organization of critical activities related to the production and monitoring aspects of the process / product.

 

The 11th edition of the "Microbiology Days" is focused on the most striving challenges launched by the revision of the Annex1 and related to new technologies' evolution and provision of sterile drug manufacturers.

 

Representatives of Institutions, Opinion Leaders, experts of Pharmaceutical Companies, Technology Suppliers ed experts in Microbiology, will participate at the 2 days with specific lectures and round tables on the different topics, focussing on providing an updated overview and 

 

The debate will focus on what will be the future Inspection requirements?  How QRM will become a contamination integrity control strategy ? How will be addressed a Validation and Process Control Strategy ? How continuous monitoring will be implemented? What's new and what are the  expectations on identification in out-of-bounds and in the Data T rend? How we will have to face the design studio of the Aseptic Process Simulation? What possible developments on Pupsit? Which application evolutions for the Altnernative methods?

 

XI MIcrobiology Days is a 2-days congress which offers 6 dense lecturing sessions, round table and time for networking (coffee break, lunch and evening aperitif) with a whole exhibitions area dedicated to discussion spaces and sponsors/exhibitors to showcase and present all latest technologies.

 


Microbiology Days - Sponsors

Sponsor /Exhibitors list is updated on a regular basis. Stay tuned!

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Stand out of the crowd: become a Congress Sponsor!

Become a 2018 Congress Sponsor or exhibitor and play a leading role among a powerful community of international experts!

Contact Claudia De Rosa, our Sponsorship & Sales Account Manager  at cderosa@pharmaeducationcenter.it or by phone at +39 347.0492499