Second appointment with Virtual GAMP Forum to talk about safety and risk mitigation in the Pharmaceutical World and ServiTecno always present among the speakers.

Also this year ISPE and GAMP Italia are organizing the traditional GAMP Forum in a "virtual" version with two afternoon webinars, in which some of the most current and challenging topics for compliance will be dealt with: read below the complete agenda of the Webinar to be held Tuesday 25 January.

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ServiTecno will make its contribution to the event with a speech by Mario Testino who will talk about Cyber ​​Security Requirements in connectivity projects, or what are the best practices and precautions to consider in the processes of convergence between IT and OT in the Pharma world.

Tuesday 25 January 2022

Chairman Pier Luigi Agazzi – GAMP Italia Group

  • 14.30 Introduction of ISPE Italy
    • Enzo Lacchini
      President of ISPE Italy
  • 14.40 Introduction of GAMP Italia and Cyber ​​Security Group
    • Sandro DeCaris
      President of GAMP Italy
  • 14.50 Management and validation of massive data operations: Migration, Loading, Carve-out and decommissioning of old systems
    • George Civaroli
      Senior Principal Consultant – LifeBee
  • 15.15 Self assessment checklist: simple and effective tool for an initial assessment on the cyber posture of a pharmaceutical company
    • Mario Testino
      Chief Operating Officer – ServiTecno
    • Luca Zammarchi
      Digital Governance International Delivery Director – PQE
  • 15pm Virtual Coffee Break
  • 15.45pm Sponsors
  • 15.50 Change Management, IT/OT/Cloud convergence and Cyber ​​Security which rules of engagement? Some examples and use cases.
    • Enzo Maria Tieghi
      ISPE Working Group Cyber ​​Security
  • 16.10 The management and secure sharing of company data from users outside the company. The experience of a manufacturer of automatic machines.
    • Pier Luigi Vanti
      ICT & Industry 4.0 Corporate Director IMA Spa
  • 16:30 Organizational and IT/OT integration examples: a use case of IBSA Institut Biochimique SA
    • Andrea Pagni
      Application Manager - IBSA
    • Giuseppe Bungaro
      Head of Information Technology, IBSA Group
  • 16:50 Q&A session
  • 17.00 Closure

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in the first webinar held on December 2, 2021, there was talk of:

  1. For Data Integrity, for which there are still ongoing remedial activities, we will be able to benefit from the now finally definitive indications of the PIC/S 041 guideline of July 2021 (the guideline of international inspectors) presented by Sandro De Caris, President of GAMP Italia .
  2. Integrating the production lines with corporate IT systems is a costly activity due to the heterogeneity of the systems in the field, but indispensable for improving the quality, data integrity and at the same time also the efficiency and knowledge of the process. We take stock of the integration of production machines with the intervention of an international speaker from the international ISPE group Pharma 4.0 Plug & Produce.
  3. Continuing the intervention of the international speaker, one of the Italian representatives of the group will explain the details of the work done in the field of Pharma 4.0: and Plug & Produce at ISPE International level.
  4. The results of the GAMP Italian Connected Machines working group will then be presented, which is working on the drafting of the requirements for the integration of the machines with the contribution of pharmaceutical users, the main Italian machine manufacturers, Industrial Automation players and consultants .
  5. Complementing the previous speech, the Cyber ​​Security requirements in the machine integration projects developed in collaboration with the specific GAMP Italia working group will be illustrated (an absolute novelty).

In the next webinar, on December 2nd, the topics related to the Cybersecurity through the presentation of the activities of the related GAMP working group. We will see some managerial and organizational examples adopted by companies, end users and machine manufacturers.

In addition, you will have the opportunity to explore the aspects and criticalities of managing massive data operations.

Consult the complete document: 2021 ISPE Pharma 40 GAMP

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Program

 

Thursday 2 December 2021

Chairman: Beny Fricano – IMA

  • 14.30 Introduction of ISPE Italia Enzo Lacchini
    President of ISPE Italy
  • 14.40 Introduction of GAMP Italia
    • Anna Lidia Vignoli
      GAMP Italy Vice President
  • 14:45 The PICS 041 guideline on Data Integrity final version.
    • Sandro DeCaris
      President of GAMP Italy
  • 15.15 Introduction to ISPE Pharma 4.0 Plug & Produce (in English language)
    • Josef Trapl
      Head of MSci Innovation GMS /
      Manufacturing Science – TAKEDA
  • 15.45pm Virtual Coffee Break
  • 15.55 Sponsor presentation
  • 16.00 Spotlight on Pharma 4.0 Plug & Produce (in Italian)
    • Joseph Menin
      Pharmaceutical Industry Manager
      COPADATA
  • 16.25 A URS template to simplify data integration between machines and IT systems proposed by the working group
    “Connected Machines”

    • Marco Bellentani
      Product/Validation Manager
      MG2
  • 16.50 Cyber ​​Security requirements in connectivity projects and introduction to the new GAMP Italia "Cyber ​​Security" working group
    • Mario Testino
      Chief Operating Officer – ServiTecno
  • 17.15 Q&A session
  • 17.30 Closure