COURSE OBJECTIVE:
This course provides a comprehensive coverage of the method development and validation requirements that are essential in Quality Control Laboratories of Pharmaceutical and Bio-Tech Industries at each stage of product development & regular manufacturing. And also to provide an understanding of the Raw material, Packaging material, In-process and finished product testing along with Accelerated, Intermediate and Real time Stability studies
DESCRIPTION AND OUTLINE:
Analytical methods must be validated to provide reliable data for regulatory submissions. These methods are essential for a number of purposes, including testing of Raw Materials, testing of In-process Material, FG testing, testing of stability samples, testing of reference materials and to provide data to support specifications.
Method Validation definitions, essential pre validation activities, protocol preparation and execution, deviations and change controls, summary, certification, ongoing monitoring, revalidation.
Accuracy, Precision, Specificity, detection limit, quantitation limit, linearity and range, ruggedness, robustness, limit of detection, limit of quantification. Laboratory mathematics, laboratory records, USP monographs
Formulation / Standardization / Expiration dating for VS, TS, BS, Dissolution media, mobile phase, internal standard solutions. Reference standards, UV / VIS / IR Spectrophotometry, Chromatography, Auto-titrations. Sampling techniques, identification tests, limit tests, in-process tests, assays, test for uniformity of dosage units.
Dissolution and drug release, related process tests, assays, test for uniformity of dosage units. Dissolution and drug release, related compounds, degradation products, TOC, total aerobic microbial counting, pathogens, undue toxicity.
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
