This course is designed to explain why regulatory agencies require Validation, as well as the consequences of failing to validate processes & systems. Attendees will gain a broad general background in validation and in addition also the practical application of equipment and system qualification. The course will provide a walk through the different general steps in validation, the concrete steps for qualifying equipment/ systems, the qualification methods and the “key deliverables”. After the training the trainees can apply a basic structure for the necessary qualification documents (protocols/report) and document in a correct way.
FDA 21 CRF, FDA guidance on process validation, EU V4 Annex15, EU V4 Chapter 4: Documentation
Practical training given by experts with experience in various domains. The participants will gain sufficient background and tools to work with. A come back session is planned to discuss the trainee experiences in the field.
At the end of the course participants will be able to
Basic validation course containing general concepts + specifics on equipment/system qualification Pharma & life science
Antwerp, Blue Point, Filip Williotstraat 9
Price per day: 750 €/excl. VAT
30 % discount for early birds (subscription before 30th of March 2019)
Until 50% discount through KMO portfolio or training vouchers (DV.O218731)
Full reimbursement through Co-valent : https://www.co-valent.be/
50% discount for students and PHD’s