GAMP 5 and Data Integrity – Trends for Manufacturing Systems

Time: 12:00 pm - 12:30 pm

Date: 27 April 2022

27-04-2022 12:00 27-04-2022 12:30 Europe/London GAMP 5 and Data Integrity – Trends for Manufacturing Systems

In recent years there has been concern about the integrity of the data used to release pharmaceuticals from the manufacturing stage to the market. This presentation takes a look at the current guidance on how to identify threats to this data, and how to ensure the data is not compromised. The presentation explains ‘Data Integrity’,… Read more »

Making Pharmaceuticals

Synopsis

In recent years there has been concern about the integrity of the data used to release pharmaceuticals from the manufacturing stage to the market. This presentation takes a look at the current guidance on how to identify threats to this data, and how to ensure the data is not compromised.

The presentation explains

  • ‘Data Integrity’,
  • What is meant by a computerised ‘Manufacturing System’,
  • the sorts of data being collected,
  • how to define what is critical,
  • the data lifecycle
  • the risks associated with the data,
  • how the risks are controlled

 

Speakers

  • Hilary Mills-Baker European Quality and Validation Manager - Emerson Automation Solutions

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