Overview

Stability studies are required to be conducted for market approval of new and existing bulk actives as well as all kinds of finished products by USFDA, EMA, MHRA, CDSCO and all other National regulatory agencies. These studies are generally carried out according to the ICH/WHO guidelines, which duly define stability test protocols, both for drug substances and products. Nevertheless, to successfully execute and implement the stability testing program in industry, there are myriad of additional requirements, beyond those enshrined in the regulatory guidelines.

A masterclass has been planned for the staff and management in pharmaceutical industry, to refresh them with essentials of a successful stability testing program. This masterclass assumes importance as stability-reasoned warning letters and product recall orders are being issued in significant number to Pharma companies. Also, the latest GMP guideline issued by Indian Ministry of Health and Family Welfare has enhanced emphasis on stability testing of pharmaceuticals produced and sold in the country.

The masterclass will be held on April 12, 2024 in virtual mode (1.00 pm to 5.00 pm), and is brought to you by Glostem, a Global Science Technology Event and Marketing Organization.

Topics Proposed to be covered:

     1. Stability department organization
     2. Stability study design
     3. Standard operating procedures
     4. Sample management
     5. Sample storage
     6. Sample analysis
     7. Data analysis, review, and approvals
     8. Regulatory reporting
     9. Key latest developments

Who Should Attend: 

Pharmaceutical scientists and managers working in the formulation, analytical R&D, regulatory, QA/QC, and manufacturing departments in Industry, and also staff and management of CROs and Testing Laboratories.

Organizing Secretary

Ms Swati Kanwar, Email: s.kanwar@glostem.com; M: 8289015050

Forum Manager

Ms Farheen Zainab, Email: f.zainab@glostem.com; M: 7696225050