phvqa
Pharmacovigilance QA – The next big thing in Pharmacovigilance!
In the last few years, after having audited numerous service providers/ business or licensing partners/ distributors etc., I realized having developed fascination towards this off-shoot of PhV, that is #PhVQA. Thanks to the GVP modules as well as PSMF pre-requisites, coupled with the requirements for MAH to maintain a 2-5 yearly audit schedule, making it […]
Change Controls – Effective project management tool!
Quite often in Pharmacovigilance department, you would find people who get annoyed upon hearing terms such as deviation, CAPA and change controls. If utilized properly, change control can serve as an effective project management tool. Considering the dynamic nature of the Pharmaceutical business, it is essential that the Pharmacovigilance department does not miss out on […]