Master Validation planning

My employer (IVD medical device manufacturer) wants to make me the validation manger in 6 months time, but first they want to hire a consultant to address and plan for the issues that we are lacking in. He would be helping and mentoring me, but first i think it is a good idea to develop a plan and determine what aspects need to be tackled.

can anyone (everyone) please give some input on what aspects of the system needs to me addressed from a validation aspect.

All help would be appreciated

Are you going to be the validation manager for all validation activities in the plant, i.e including cleaning, process, laboratory etc?

yes for all activities, just FYI ofcourse we claim CFR, ISO compliance and are goign to be looking into MDD soon

This is a very big question, but basically you need a Master Validation Plan, which covers all the various different aspects of Validation that will be applicable to your company.

You will need the input from the various different SME’s to put this together.


hmmm… i guess what i am asking what are the major aspects that should be addressed immediately so that we may be able to hire the right person to help write the master validation plan, specifically for operations in the IVD industry

Graham i am unable to send you a PM as your mailbox is full

Dont worry I got it, I will reply soon