Genotoxicity is an essential endpoint to be evaluated to ensure safety of medical devices. ISO 10993-3 describes methods of detection of genotoxicity, carcinogenicity and reproductive toxicity hazard. This on-demand webinar will focus on assessment and evaluation of genotoxicity and will also discuss testing strategy as per the regulatory requirements.
Manufacturers will gain insights on key challenges faced while choosing the right tests for genotoxicity as well as the possibility of waiving off tests in specific situation and correlation with other parameters since genetic damage may lead to other serious hazard like carcinogenicity and reproductive toxicity.
Introduction to Genotoxicity
Overview of Genotoxicity Assessment and Evaluation
Dealing with positive and false positive results
Q & A
Dr. Shailendra Singh
General Manager & Head of MHS-South Asia
Dr. Shailendra Singh is Doctorate in Biochemistry. He investigated various aspects of cellular biochemistry during his doctoral research. He has been heading Medical & Health Services (MHS) Business Unit of TÜV SÜD South Asia since 2019. He has many years of experience in Pharmaceuticals and Medical Device Testing Labs in India and Europe and held several positions leading Genotoxicity, in vitro safety assessment and Quality Assurance teams.
He is an expert of Biocompatibility with a strong knowledge in General Toxicology, genotoxicity and in vitro alternative methods and having extensive experience in Risk Assessment and Biological Safety Evaluation. Responsible for testing business of South Asia, Africa and Middle East. Within TÜV SÜD, he is responsible for divisional operations of MHS business unit of South Asia.
Sign up for the rest of the ISO 10993 webinar series here.