With FDA’s new Process Validation Guidance validation requirements will become more complex.
In addition to other requirements the revised Annex 15 also asks for a Process Validation Life Cycle. For ‘ensuring that all necessary validation is carried out’ (EU GMP Guide), many firms have introduced a position called validation manager. For this reason, the ECA has established the Certified Validation Manager Module. Attend a compulsory course, “The Validation Manager”, as well as two further courses from our validation programme to obtain the certificate for this high-level additional qualification.