Module 1: Process Validation: an Overview 

You will learn why you need to perform validation, what it means and where this is necessary. Validation is recommended to ensure your process demonstrates stability in the manufacture of your medical devices, very often processes can drift including temperature, pressure and time. Any controls should be calibrated while the whole system needs validation. This must be done by testing the outputs of the process against predefined acceptance criteria. 

Module 2: IQ/OQ and PQ – Qualification in more detail (including Statistical techniques, process capability) 

Qualification is the heart of any good validation, when performing validation doing this right and in the right order is essential for best practice. Installation, Operational checks and Performance checks are all part of validating a process, equipment or system. In this lesson we will discuss how you should perform each of these stages with good documentation practice. 

Module 3: Packaging Validation (Including Sterilisation, Cleanroom Validation, Shipping Testing) 

If you have sterile packaging or even non-sterile packaging of a Medical Device it is essential to ensure that the process used is validated. There are essential standards to follow such as ISO 11607, EN 868, ISTA, and ASTM standards. In this lesson, we will indicate the important tests to perform for good integrity and safety of the package. 

Module 4: Equipment Software Validation (Black Box, White box and Gray box testing) 

Several pieces of equipment use firmware or software encoded within an EPROM controller which requires validation testing. If the equipment is highly automated then the chances are the equipment is programmed with complex software code which can be very specialised code, this will need validation. In this lesson, we will go over the different methods of software validation.