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.
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