Dr. Ambekar Abdul Wahid

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