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The final draft has 59 pages, which is dramatically longer than the 16-page 2008 version. This revision is a complete rewrite of the annex and was a joint EU, PIC/S, and WHO project, with US FDA personnel actively involved. The new Annex 1 revision must be implemented within one year
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of its issuance, by August 25, 2023.The cGMP Annex 1 Workshop will feature industry experts who will provide practical solutions for implementation of the new guidelines at your organisation. These experts were intensely working on commenting and developing solutions for Annex 1 changes throughout the entire seven-year process since the publishing of the first draft of this virtually new guidance. They will provide a unique expertise on the gap issues you may have in your facility regarding Annex 1 implementation and can recommend a viable path forward. Attending this workshop will help your organisation avoid regulatory scrutiny and numerous observations.
Highlights
- Principles and Pharmaceutical Quality Systems
- Equipment, Technology, and Utilities
- Production Technologies
- Contamination Control Strategy Development
- Decontamination and Sterilisation of Direct and Indirect
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Timings8:00 AM - 6:00 PM (General)
| Entry FeesPaid Ticket Starts from 695 EUR View Details |
Estimated Turnout50 Delegates 10 Exhibitors | Event TypeWorkshop |
EditionsMay 2023Frequency One-time | Official LinksWebsiteContacts Report Error Claim this event |
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41.4037902.191298 Venue Map & Directions | |
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Visitor Ticket Price
| 995 EUR | DelegatesAccess to full workshop, daily networking, refreshments, pre-event meeting, business dinner |
| 695 EUR | Group 3Access to full workshop, daily networking, refreshments, pre-event meeting, business dinner |
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12 May 2023
Lucie MusalkovaVisitor Czech Republic at OncomedBrno, Czech Republic
Inspirational, professional, deffinitely worth it.
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EditionMay 2023
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Ofori Agyeman-Badu
Student
Barcelona, Spain
Paul van Staalen
Media Consultant
Barcelona, Spain
Jasna Nuhic
Barcelona
Barcelona, Spain
Pietra Stanicki
UBA
Barcelona, Spain
Marco Patiño López
Student
Barcelona, Spain
Idil KOTTAS
Teacher
Barcelona, Spain
Ira Mirra
Designer
Barcelona, Spain
Masha Churilova
Design Consultant
Barcelona, SpainView More
Speakers
Speaker
IGOR GORSKY, US
Principal Process Validation Consultant at ValSourceSpeaker
MORCOS LOKA, EG
Training Manager & GMP Advisor at MinapharmSpeaker
WALID EL AZAB, BE
Technical Service Manager, STERIS CorporationSpeaker
YOSSI SHAPIRA, IL
Consultant and Owner, Containment Lyophilization Laboratories (CLL)Speaker
KEVIN OWEN,UK
Director of Aseptic Technologies - EMEA, IPS - Integrated Project...Schedule & Agenda
Filter By| Tue, 09 May 08:00 AM - 09:00 AM | Opening Ceremony Registration Open of training | |
| Wed, 10 May 04:00 PM - 06:00 PM | Closing Ceremony Closing Speech Panel discussion / End of training | |
Visitor Ticket Price
| 995 EUR | DelegatesAccess to full workshop, daily networking, refreshments, pre-event meeting, business dinner |
| 695 EUR | Group 3Access to full workshop, daily networking, refreshments, pre-event meeting, business dinner |
41.4037902.191298
Venue Map & Directions
Avinguda Diagonal 201 08018 Barcelona
Spain
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