This course aims to develop contemporary understanding of process validation in order to comply with regulatory expectations. In addition, it reviews the objectives and standard practices. and provides practical directions on how to use quality risk management principles to prepare validation plans that meet current regulatory expectations.
- The GMP reasons for process validation
- Strategies for process validation that complies with cGMPs
- Essentials of a process validation protocols
- Requirements for re-validation and give examples of situations that would give rise to it
This course has been designed for validation professionals as well as those involved in approving process validation plans and projects. It also applies to anyone interested in the latest trends and methodologies in process validation that are rapidly becoming industry standards.
Format and Course Length
The course will be delivered as an online virtual-classroom training session.
Participants will be provided with a PDF of the training material in advance of the training should they wish to print and annotate notes. Participants will be connected to the trainer and other participants via online collaboration tool Zoom with connected video (webcam / screen sharing) and audio (computer audio or phone dial-in). Theory will be delivered by the trainer sharing their screen of the PowerPoint presentation. Facilitated workshops will be run in digital breakout rooms (e.g. a group of 12 might split into 4 breakout rooms each with 3 participants to separately work on a problem). Breakout rooms can call the trainer in for support when required and the trainer can electronically bring everyone back to the main session to debrief when appropriate.
The training will be delivered as 1 full day session with breaks.
PDF Certificates will be provided to participants electronically.
Contact us to discuss your interest in a public or private delivery of this course on-site or in a virtual-classroom.