GAMP 5 and Data Integrity – Trends for Manufacturing Systems

Time: 12:00 pm - 12:30 pm
Date: 27 April 2022
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
« Back