Dr. Ambekar Abdul Wahid

cdsco licensing objectives process validation manufacturing layout plan. stability data flow chart for registration cost of manufacturing license. sops and stps. who-gmp requirement. importance of copp renewal authorization ectd copp functions of cdsco 1940 drugs & cosmetics act new delhi fda bhawan indian regulatory requirements cgmp discovery/development team clinical research team guidance for the investigator summary of data marketing experience safety and efficacy effects in humans toxicology non-clinical pharmacology investigator’s brochure (ib) importance of ind ind non clinical phase of drug pre-clinical drug development teams role of r a professionals various regulatory authority role of regulatory affairs dep different types of licensing mous confidentiality agreements tt documents sidbi biotech consortium india ltd tifac apctt t t agencies in india multi-disciplinary technologi advantages patient safety platform technology gmp consideration master manufacturing process evaluation steps in scale up pilot plant scale- up gap analysis ru’s responsibilities analytical method transfer technology transfer documents technology transfer process granularity technology transfer virtual labs. electronic batch records (ebr) software enterprise resource planning (erp) computerized physician order entry (cpoe) pharmacy informatics role of it in pharma industry case study offenses and penalties class of prohibitions advertisement - section 3 definitions drugs & magic remedies act (objectionable advertis list of amending acts and adaptation orders. offences and penelties joint state pharmacy council state pharmacy council pci the pharmacy act 1948 amendments offences and penalties power to control and regulate controlled substance control and regulation prohibition national fund for control of drug abuse the narcotic drugs and psychotropic substances con authority and officers various definitions under ndps history of ndps act ndps act 1985 pricing of bulk drug and formulations salient features of dpco 2013 dpco 2013 organization of nppa functions and responsibilities of nppa nppa process stages types of spray drying systems design of spray dryer application of spray drying spray drying