This course covers related definitions with images, calculations of limits, classification of impurities with example, How to include them in the specification, regulatory requirements and presentation in drug master file
M.Sc/B.Sc/B.Pharm/M.Pharm/MBA/ PhD/ Working professionals from Pharma/Bio-tech industry [QC/QA/R & D/F & D/ ADL/ RA/ Patents/International business etc] & those aspiring to enhance their regulatory affairs knowledge.
Anyone willing to understand this topic can enroll.