For years, the topic validation/qualification has been among the top deviations in FDA‘s warning letter statistics. This is true both of pharmaceutical manufacturers and of the API industry. Other frequent citations refer to the related topics cleaning validation and change control. What is also checked during inspections – and mentioned in warning letters – is computer validation. In order to give you a broad overview of the cGMP requirements on the whole range of validation/qualification, we have designed this practice-oriented 2-day Validation Manager GMP Education Course. In many pharmaceutical and API enterprises, the Validation Manager has become an established function.
One focus will be on the FDA Guidance on Process Validation of 2011. What are differences, what are similarities to European validation Guidelines?