In this webinar Vipul Doshi -Chief Quality and Compliance Officer at Zydus Cadila will discuss GMP compliance in Aseptic Processing – What the EMA & FDA Expects.
Dr. M. Damodharan : In this webinar, Sai Life Science is presenting the industry first such solution deployed successfully and their benefits in handling instrument integration, data storage and archival functions and heading towards the fully paperless lab.
Paul Lopolito & Richard Chai : Sustainability is a common goal within the USA, Europe, Asia, and other parts of the world, but the approach to sustainability will depend on the site, corporation, locality, national regulations, culture, people, manufacturing process, and environmental influences. This presentation shares some of these examples.
Nissan Cohen & Susan Cleary - The presentation will cover the new (changed) regulations, what it means for the pharma industry. The talk will also discuss points about automation, and device connectivity for inline monitoring on water system, and continuous monitoring, as well as managing and trending the data to meet with regulatory requirements.
Zuwei Jin : Main Topics covered in the Webinar:
Introduction Of MVDA application in CPV
How MVDA works
How on-line MVDA works
How CPV can be achieved throughout stage 1, 2, and 3
Dr. Thomas Kipping will present a novel melt drop technology where the 3D printed geometry is created by individual deposition of polymer droplets.
Saroj Ramdas : In this webinar you will learn Various tools and approaches defined in ICH Q12 to facilitate CMC change management including
Established Conditions (ECs)
Risk-Based Reporting Categories Product Lifecycle Management (PLCM) Document
Post-approval Change Management Protocol (PACMP)
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
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