COURSE OBJECTIVE:
To provide an understanding of the Controls related to Procedures (manufacturing, quality testing, cleaning, change control and all Kind of SOPs ) Practices (GMPs, GLP, GCP, GSP, GDP etc.) and Good Documentation Practice (GDP) in Pharmaceutical and Bio-tech Industries.
DESCRIPTION AND OUTLINE:
Quality assurance activities in specific issues like ware house control, raw material control, product containers / closures / packaging material control, manufacturing control, laboratory controls, facility qualification, validations, stability and calibration programmes, labels and labelling, water system electronic records and signatures, annual product electronic records and signatures, annual product reviews, handling summary reports, deviations and change controls, form 483’s and FDA or other regulatory warning letters.
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
