The course will cover qualification and process validation, from EU and US perspectives, considering both small and large molecule aspects, plus it will include a half day to consider qualification and process validation for ATMPs.

The early part of the course will concentrate on ensuring understanding of patient drivers and manufacturing process steps. It will cover fundamentals for product and manufacturing processes and how the purpose and function of equipment, utilities and facilities relate to these, and hence the need for these systems to be appropriately qualified and validated.

It will cover details on EU and FDA guidance documents, and their application in validation/qualification, plus input on the relatively recently updated ICH Q9R1 on Quality Risk Management and how this impacts commissioning/qualification.

The course will explain the various steps for qualification and validation, including understanding the importance and key content for good User Requirements Statements (URS), followed by appropriate IQ (Installation Qualification), OQ (Operational Qualification) and continued/ongoing process verification (CPV/OPV). It will consider how much documentation should be produced by ‘client’ companies vs the information provided by engineering facility/ utility/ equipment suppliers and installers.

Finally, it will also cover process validation (PV) including the lifecycle from QTPP (Quality Target product profile), CQAs (Critical Quality Attributes) and CPPs (Critical Process Parameters), material attributes and how to determine the number of PV batches.

Included in the 3 days will be how these aspects impact ATMPs, be they autologous or allogeneic.

The training will include information and experience on this topic and will, as much as is possible, align to attendees’ particular requirements.

Attendees will have the opportunity to see inside the processing suite and visit the facility and its plant room.