COURSE OBJECTIVE:
To provide an understanding of Accelerated, Intermediate and Real time Stability studies and provides with a description of this unique type of data and analysis, what tools can and cannot be used and why, how to best analyze life data and how to properly interpret and communicate the results obtained. Special emphasis is put on the practical application of the techniques for shelf-life studies by means of examples and discussions.
Shelf-life and stability studies are costly and time-consuming to carry out. It is important to know the key elements in setting up efficient studies. Moreover the data collected are often censored and require adapted statistical analysis tools.
DESCRIPTION AND OUTLINE:
Objectives of Stability Testing, Why Stability Studies are necessary, Stability testing of Active Pharmaceutical Ingredients (APIs), Stability Testing of Finished Pharmaceutical Products (FPPs), Variables that might affect the Stability of a given API or Dosage Form, Development Studies, Confirmatory Studies,
ICH Stability Guidelines: Q1 A (R2) Stability Testing of New Drug Substances & Products, Q1 B Stability Testing: Photostability Testing of New Drug Substances & Products, Q1 C Stability Testing of New Dosage Form, Q1 D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances & Products, Q1 E Evaluation of Stability Data.
Critical elements of a Stability Programme: Accelerated testing, Intermediate testing, Stress Testing, Climate Zones (Zone I, II, III, IV {Zone IV a, IV b}),The documentation required – SOP’s; Protocols; Reports, Stability samples & storage conditions, the qualification, management & monitoring of stability chambers, Stability Methods & Validation, Failure investigation – OOT & OOS Statistical Analysis & Trending, Results – evaluation & reporting
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
