COURSE OBJECTIVE:
To provide an understanding of the Measuring Equipment/Instrument Calibration, Equipment/Instrument/Utilities Qualifications (DQ, IQ, OQ and PQ), Process Validation (Prospective, Concurrent & Retrospective), Cleaning Validation, Analytical Method Validation & Revalidations.
DESCRIPTION AND OUTLINE:
Instrument calibrations, equipment installation qualification, Operational/performance qualification and facility qualification, Validation definitions, master plan, essential pre validation activities, protocol preparation and execution, deviations and change controls, summary, certification, ongoing monitoring, revalidation, Cleaning validation, Computer Validation, analytical method validation (ICH and USP guidelines), prospective, retrospective and concurrent process validation
COURSE FEATURES:
DURATION:
4-5 Hours a Day twice a week for about 7-8 weeks
(On Saturdays & Sundays to suit the working professionals / Industry)
MODE OF DELIVERY:
The total Study Material will be provided at the beginning of the course itself.
Direct Interaction with Subject Matter experts
4-5 Weeks of Class room Study
1-2 Weeks of Practical Exposure
1 Week for summing up
DURATION:
4 Hours a week for about 12 weeks
(Preferably in early Mornings & Evenings on Saturdays & Sundays)
MODE OF DELIVERY:
Total Study Material will be provided at the beginning of the course itself.
Online Interaction with Subject Matter experts through webinars
