Overview
Stability studies are required to be conducted for both small and large molecules and for all finished products i.e. tablets, capsules, injectables, topical preparations powders and complex pharmaceutical products for both innovators and generic manufacturers. These studies should be conducted for market approval by US-FDA, EMA, MHRA and all other regulatory bodies and are conducted according to the ICH Guidelines. Stability study program defines storage conditions that could influence the quality of a drug substance or drug product depending on a variety of environmental factors such as temperature, humidity, and light. A stability study program is a very well planned, executed and documented set of studies conducted in stability chambers followed by analysis and require a thorough understanding of the product and processes to which the pharmaceutical product is being subjected to during its lifecycle.
This masterclass has been designed to refresh the pharmaceutical scientists working in the chemical, formulation, regulatory and analytical R & Ds with the most important information related to conducting stability studies in pharmaceutical industry so that they can design and execute an effective and successful study program. This masterclass will be held on April 8, 2022, virtually (1.00 pm to 5.00 pm) and is brought to you by the organizing team of Advances in Forced Degradation Studies of Pharmaceuticals conferences in Hyderabad on 21 November 2014.
Who Should Attend
Scientists, Managers, Research Associates from Pharmaceutical industry from Research, API/Formulation Manufacturing, Analytical, Regulatory departments, CROs and Testing Laboratories as well as experts in Pharmaceutical Stability Testing and Impurity Profiling, Pharmaceutical Analysis as well as Organic Synthesis.
Contacts
Technical Query: Ms. Pooja Sharma, M: 7696325050, Email: p.sharma@glostem.com
Participation Query: Ms. Swati Kanwar, M: 8289015050, Email: s.kanwar@glostem.com
Registration Query: Ms. Ankita Kanwar, M: 7696425050, Email: ankita@glostem.com
Experts
Saranjit Singh
Professor (Retd.),
National Institute of Pharmaceutical Education and Research, India
Conference Agenda
- ICH Stability Guidelines and Worldwide Stability Requirements ICH Q1, Guidelines by - FDA, EMA, MHRA, ASEAN, ANVISA, Quality Metrices
- Stability Testing, Stress Testing, Photostability and In-use Stability Study Design and Testing, Bracketing & Matrixing, Chambers, Forced Degradation
- Development and Validation of Stability-indicating Methods Method Development, Customization, Risk-assessment, Robustness
- Management of Stability Program Risk areas, Data integrity, User Requirements, Reporting
other conference
