COURSE OBJECTIVE:
To provide an understanding of the Document writing, document review, document approval, document control and Good Documentation Practice to comply the regulatory guidelines.
DESCRIPTION AND OUTLINE:
Standard operating procedures related to warehouse, production, packaging, quality control, validation and quality assurance departments. Master manufacturing documents, master packaging documents, in-process control documents. In house and compendial analytical methods, raw material, in-process material, packaging material, finished product specification cards, validation summary reports, document review forms, process, qualification, analytical method and validation deviation forms, Out of specification reports, document control, drug master file and dossier.
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
