COURSE OBJECTIVE:
The program is designed to address all innovations and rapid changes affecting the Formulation Development and Process Validation in Pharmaceutical & Bio-technology Industry.
DESCRIPTION AND OUTLINE:
Goals of pre-formulation, pre-formulation parameters, methodology, solid state properties, solubility and partition coefficient, drug excipient compatibility, Physico-chemical factors, formulation factors that affect bio-availability. Problems and rectification in manufacturing, filling / coating / packaging of tablets & capsules. Problems and rectification in manufacturing, filling & packaging of Liquid Orals & Parenteral preparations. Stability testing programs for new active substances & dosage forms in their final packaging. Phase-I, Phase-II, Phase-III and Phase-IV studies in clinical trials, NDA & ANDA Submissions.
Validation definitions, validation master plan, essential pre validation activities, protocol preparation and execution, deviations and change controls, summary, certification, ongoing monitoring, revalidation, prospective process validation, retrospective process validation 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
