| Author | Message | ||
     Jodhaa Side Hero Username: Jodhaa Post Number: 7365 Registered: 02-2008 Posted From: 65.186.82.73 Rating: N/A |
Janalu okka job kosam worry avuthuntey, meeku bhaley ga vasthunnaye opportunities...  | ||
| Batthar_bindaas Side Hero Username: Batthar_bindaas Post Number: 8452 Registered: 12-2006 Posted From: 155.94.62.222 Rating: N/A |
mama... naa understanding and experiances tho konni chepthunna.... 1.Responsiblities antey depending on your seniority level and your understanding of FDA regulations.... GXP.... SDLC meeda depend avuthayi.... 2.normal companies lo testing/QA/validation antey regulations emi vundavu.... antey nee systems ni ila validate/test cheyyali ila rules follow avvali etc ani....adey pharma industry lo FDA is a governing body and it has some regulations for electronic systems.... so aaa regulations ki oka code 21 CFR Part11 etc ani petatru.... vintaniki rocket science laaga vunna lopala emi vundadu....peina pataaram lona lotaram types .... 3. So company lo vunna any electronic system like..Data bases.... vendor softwares.... OS.... ERP etc anni validate cheysi vundali as per FDA guide lines..... 4. So layman ga ayithey nee responsiblities.... Test scripts rayatam.... dry runs etc cheyyatam...bugs report cheyyatam.... scripts execute cheyyatam etc vuntai.... 5. konchem senior level ithey .... validation plan...summary reports....traceability matrix develop cheyyatam.... risk analysys cheyyatam.... mitigation plan rayatam for the risk involved.... final ga IQ/OQ/PQ summary reports prepare cheyyatam..... etc etc antey mostly deliverables prepare cheyyatam ana maata..... so brief ga idee matter..... emanna doubts vuntey adugu ...naaku telsinantha lo cheptha.... | ||
| Goonda Hero Username: Goonda Post Number: 11078 Registered: 02-2007 Posted From: 146.18.173.74 Rating: N/A |
bhayya, mana DB member, Battar_Bindas, ee field loney work chestadu.. oka calling thread esuko.. vachi cheppi potadu | ||
| Andhrawala Junior Artist Username: Andhrawala Post Number: 573 Registered: 03-2008 Posted From: 192.58.204.226 Rating: N/A |
CFA Part 11 gatraalu soosukovaaali. SOPs gatraa vuntaayi. avvi follow ayye documentation vuntaadhi. More of documentation work than real testing different types of Val are Comp Validation, Process Validation and Instrument Validation | ||
| Kalikaalam Junior Artist Username: Kalikaalam Post Number: 1000 Registered: 01-2008 Posted From: 167.230.38.118 Rating: N/A |
Thanks chivuks | ||
| Chivuks Comedian Username: Chivuks Post Number: 1015 Registered: 07-2008 Posted From: 64.103.134.96 Rating: N/A |
http://www.csscomp.com/web/toplevel/pharmaceutical_software_ validation.htm | ||
| Kalikaalam Junior Artist Username: Kalikaalam Post Number: 999 Registered: 01-2008 Posted From: 72.78.110.209 Rating: N/A |
maamalu, Software validators ane vallu Pharma Industry lo chese duties and responsibilites yemito konchem cheppandi. Resume lo include chesukovadaaniki. Inti daagaara lo oka job open ayyindi. Daily 4 hours commute tho chachipothunnaanu(at present ;Agile tester; gaa chesthunnaanu) Chaalaa thanks maamalu |
