Date

March 4, 2021

Duration

60-75 minutes

Time

4 pm CET

Level

Advanced Professional

Why should you attend?

Over the years, auditors began to realize that the industry believed that producing voluminous documentation in support of validation would impress them. During their audits they noticed that often times companies lacked an understanding of the systems they were validating, thereby defeating the very purpose of validation.

Companies try to eliminate the process silos caused by a casual organization’s mix of network document directories and paper documents ​and the companies want to switch from paper-documentation driven to paperless data-driven global network. Exploit the advantage of automation and dynamic monitoring to reduce operational and production costs​.

Paperless systems are the opportunity for the resources to develop knowledge rather than reinvent the wheel at every task or project​.

This presentation will focus on Analysis of Validation software integration​ with a Biopharmaceutical Company’s ​Validation and Qualification Processes​.

Areas covered:

  • Digitalization of validation processes
  • Fundamental about eliminating process silos
  • Advantages of automation and dynamic monitoring to reduce operational and production cost
  • Why paperless systems are the opportunity for resources to develop knowledge.
  • Electronic Logbooks in Life Science

Who will benefit? 

Professionals across: 

  • Quality Assurance/ Quality Control
  • Product and Process Development
  • Validation
  • Manufacturing and Laboratory Operations
  • Engineering
  • Regulatory Affairs
  • Automation Engineers

Instructor Bio

Giorgio Pesci & Sophia Vraka are both experienced Consultants in their domain of laboratory and in the domain of innovation and solution implementation in GxP environments. Both have more than 20 years of experience in the Life Science industry. The knowledge of Giorgio and Sophia is not only limited in  CSV, Data Integrity, 21 CFR Part 11, Annex 11 and manufacturing process automation.  Memberships in different organizations and associations like ISPE and others are developed over the years.

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