Aaron Mertens : This webinar will present technology to Maximise Sterility Assurance.
Ian Lucas will give a brief background on why CSA was introduced, and what is probably wrong and right with our current CSV approach. It will also provide practical examples on how to implement CSV within your organization.
Keith Beattie: Keith will give some personal thoughts, views and predictions based on his two decades of working on sustainability programmes with many of the leading pharma companies around the world.
Dr. Armin Hauk: A mathematical Model is presented for In-silico Forecast of Process Equipment Related Leachable ( PERLs ) in Single Use Technology.
John O'Neill -This presentation will explore the stability steps required to arrive at Product regulatory approval as well as the numerous and diverse objectives to be achieved while conducting post-approval stability studies.
Frederik Thiele : This webinar presents use of AR in Pharma Manufacturing and presents Use Case with Lion Suite.
Jim Polarine & Dan Klein : This seminar will cover a risk-based approach to an Aspergillus brasiliensis and Chaetomium contamination in a Cell and Gene Therapy Cleanroom.
Ronald Koch -In this Webinar a detailed presentation is given about the technology, use and application of the Tuneable Diode Laser Absorption Spectroscopy (TDLAS) technology for CCIT.
Joachim Ermer -In this Webinar Learn
Development towards life cycle approaches
Draft: Analytical Target Profile (ATP) and 3-Stage approach
ICH Q2 Revision and new Q14 Guideline
Tara Scherder & Keyur Doshi : In this webinar learn how science and risk-based principles can be applied across the process lifecycle .
Karen Ginsbury : The objective of this webinar is to understand what Quality is and what a QMS is supposed to do and how it should do it. Where the GMPs fit into the QMS and how, with intense and close regulatory scrutiny, is it possible to manage a truly effectiveness and robust system.
Michelle Vuolo & Dave Margetts : This webinar will contain extracts from the SIG’s work including: An introduction to Validation 4.0 based on recent PE article: ‘Laying the foundation for Validation 4.0” including an explanation of the conceptual model that is being developed within the SIG. The relevance of QbD and Pharma 4.0, using case studies on continuous verification for OSD
ISPE India held a Students Research Paper Competition 2021 wherein Research students from Academic Institutes in India submitted significant research findings of their original research work. After two rounds 12 researchers were selected to participate in the Final Round where they presented their Research Work.