Ask the Experts: Instrument Validation and Data Regulation Solutions: IQ/OQ and 21 CFR Part 11 Compliance

About the webinar

Compliant documentation in the drug manufacturing process is essential. 21 CFR Part 11 compliance software helps achieve this from raw materials to finished goods.  In addition, the qualifications of individual instruments benefit from software-supported functionality. Learn and discuss with experts how this software can be used in the spectroscopic analysis of raw materials, the manufacture of solid oral dosage forms using twin-screw extruders, and UV-Vis methods for performing dissolution testing of tablets.  We will provide a brief overview of the use and benefit of compliance software spanning various departments.

About the speakers

Suja Sukumaran, Ph.D., is a Product Manager at Thermo Fisher Scientific. She received her Ph.D. in Biophysics from Johann Wolfgang Goethe University, Germany, as part of the international Max Planck research School and is the co-inventor of US PATENTS on ‘MspA Nanopores and related methods’ licensed to Illumina Inc. She has expertise and extensive experience in molecular spectroscopy, visible and fluorescence Imaging, and protein and lipid biochemistry.Her current research interests are AI for protein folding, microplastics, and recycling.

Dirk Leister is a marketing manager for extruders and compounders at Thermo Fisher Scientific in Karlsruhe, Germany. Together with the product line team he focuses on applications for extrusion-based processes used in the pharmaceutical, food, and polymer industries. Dirk holds an engineering degree in biotechnology and started his professional career in pharmaceutical research and development. After moving to the instrument manufacturing side of the industry, he had several positions in technical sales and product management. His expertise is developing applications for process equipment used to conduct formulation research, process development, and manufacturing scale-up for pharmaceutical and bulk material handling. Dirk is adept at helping companies minimize optimization time, costs, and efforts of their continuous process scale-up.

Lauren Ebersol has been with Thermo Fisher Scientific as a product manager supporting cuvette-based UV-Vis instruments since May 2022. She works to provide the best spectrophotometers by collecting user feedback, assessing market trends, working closely with colleagues across Thermo Fisher Scientific, and using her experience in product management. Lauren received a master’s degree in chemistry from Penn State University, where she studied protein structure and function using EPR spectroscopy.


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