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Implementation of EU GMP Annex 1 in Practice


  • Ljubljana Slovenia (map)

We are delighted to announce the successful preparation of a comprehensive week-long program focusing on cleanroom technology. Throughout the week, we have curated a series of insightful workshops and assemblies dedicated to exploring various aspects of cleanroom technology. We believe that the topics covered will provide valuable insights and foster meaningful discussions among participants.

 As this is a closed event exclusively for our business partners from Novartis, Lek, and Sandoz, we're confident that it will be an exciting opportunity to delve into the world of cleanroom technology. Our event organizer, Natasa Stirn, brings over 15 years of experience as a GMP Cleanroom Consultant in Slovenia, specializing in Life Science testing and certification. Additionally, Conor Murray, Chair of the International Confederation of Contamination Control Societies (ICCCS), will be facilitating workshops throughout the week, offering invaluable insights into contamination control in cleanrooms. Furthermore, for the first two days, we'll be joined by experts from TSI to explore Bio-fluorescent particle counter (BFPC) technology, as we delve into the topic of exploring new technologies in pharma with our attendees.

Event Details:

  • Dates: March 18th - March 22nd, 2024

  • Location: Various venues in Slovenia

  • Organizer: Klimer Stirn & Co d.n.o.

 

The main speaker at workshops will be Mr. Conor Murray,

Chair International Confederation of Contamination Control Societies (ICCCS) 2022-2024, Convener ISO/TC09 WG2, Microbiological Contamination Control in Cleanrooms, Head of Delegation for Ireland at ISO/TC 209, Irish Subject Matter Expert ISO/TC 209.

 

The program will be hosted by Mrs. Nataša Štirn,
GMP Cleanroom Consultant in Slovenia, with over 15 years experience in Life Science testing and certification. She represents Slovenia and SNS as a SME and HoD on ISO/TC209.

Participating speakers at the workshops on 18th & 19th March:

Mr. Francisco Careaga, TSI EMEA Senior Regional Sales Manager

Mr. Simon Tebb, TSI Sales Manager, EMEA Global Key Account Manager

Mr. Alain Nezer, TSI Global Technical Lead & Senior Application Specialist

 

Day-wise Schedule:

Day 1 - Exploring new technologies in pharma (March 18, 2024)

    • Workshop on Bio-fluorescent particle counter (BFPC) technology

    • Venue: Klimer Stirn & Co d.n.o., Piramida Trzin

    • Note: This event is closed to registered participants from Novartis, Lek/Sandoz

           Workshops will be held in English.

 

Day 2 - Exploring new technologies in pharma (March 19, 2024)

    • Continued exploration of BioTrak implementation

    • Venue: Lek Ljubljana, Sejna soba: ambulanta (stavba direktno na Verovškovi, nasproti Tube)

    • Note: This event is closed to registered participants from Novartis, Lek/Sandoz

           Workshops will be held in English.

 

Day 3 - Cleanroom Design, Construction & Start Up (March 20, 2024)

    • Workshop on cleanroom design, construction, and initial qualification

    • Venue: Nix - event venue, Dobrave 1, Trzin (3 minutes’ walk from Klimer Štirn & Co – Piramida)

    • Note: This event is closed to registered participants from Novartis, Lek/Sandoz

           Workshops will be held in English.

 

Day 4 - Implementation of EU GMP Annex 1 in Practice (March 21, 2024)

    • Workgroup sessions on open projects and questions related to EU GMP Annex 1 implementation

    • Venue: Nix - event venue, Dobrave 1, Trzin

    • Note: This event is closed to registered participants from Novartis, Lek/Sandoz

           Workshops will be held in English.

All questions regarding the workshop, scheduled for Thursday, March 21, 2024, and about the workshop's content and topics for discussion on the workshop day itself, can be forwarded to us in advance at the email address: natasa.stirn@klimer.si

 We kindly request that all inquiries be sent to us no later than March 13th.