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 PharmaceuticalsSynopsis
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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