Introduction to Validation

Learning objective:

This training provides an overview of the various GMP (Good Manufacturing Practice) legislations that pharmaceutical companies must comply with. Both US and European legislation is shown and discussed. Participants will know afterwards where and how to find the legislation on the internet so that it is always available to them.

We work out the validation in a GMP environment in a workshop using the V-model. Using an example, the project life cycle is discussed, starting from a concept, over life cycle documents (URS, risk analysis) and qualification documents (IQ, OQ, PQ) to process validation and official commissioning.

Finally, we highlight the rules around Good Documentation Practices. We will talk, among other things, about how raw data is handled in pharmaceutical companies and highlight the importance of version control of documents.

Programme:

Definitions

GMP legislation

• US legislation (21 CFR 210/211)

• European legislation (Eudralex VOL 4)

V-model

• Project & process life cycle

Good Documentation Practices

Application of risk management

Price: 

€395.00 per person (ex. VAT)

Location: 

The training will take place at The GxP Academy at Advipro's headquarters: Wechelsebaan 143 unit 13, 2275 Lille.

Registration is required: 

please use the contact form below.

Student? 

Don't hesitate to contact us so we can look into the possibilities.