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WebCAST by amplexor

Quality Management of the next decade – journey to 2030

Date:11/18/2020

Time:1:00 PM EST

Duration:60 minutes



Complexity of everyday operations in life sciences industry is constantly increasing. To keep up with the regulatory requirements while maintaining the quality, efficacy and safety of their products in focus, the companies have to constantly re-visit their approach to processes, technology and information. Staying flexible and agile is the key. In this webinar we will take a look into new trends, learn about the potential and opportunities of implementing integral quality management platforms that seamlessly link not only activities within QA/QC departments, but also merge them into the comprehensive process that includes R&D, manufacturing, regulatory, labeling and other internal and external stakeholders. Join us to see how to manage process dependencies (from a deviation, through CAPA, over change management all the way to variation submission), cope with the transition from the classic monolithic document centric world toward the data driven and structured environment of the future, and use the power of intelligent analytics to stay in control of your processes.

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Speakers

Alexander Tryba

Managing Partner

MAIN5

Alexander Tryba is providing expert consultancy for the pharmaceutical industry since 1994. During his 20+ years as consulting professional he has led and contributed to numerous projects in the life-science industry – i.e. for Regulatory, Pharmacovigilance, Clinical, Laboratory and IT. He has a degree in Electrical Engineering from the University of Applied Sciences in Frankfurt, Germany, with focus on Computer Science and Business Administration. Alexander is co-founder and partner of MAIN5 established in 2013 and in 2016 he was appointed as Managing Partner of MAIN5 GmbH & Co. KGaA headquartered in Frankfurt am Main, Germany. He is member of the International Society for Pharmaceutical Engineering (ISPE), the German Quality Management Association (GQMA), the German Association for Quality (DGQ) and the Association of German Engineers (VDI).

Siniša Belina

Senior Life Sciences Consultant

AMPLEXOR Life Sciences

Siniša Belina is a Senior Life Sciences Consultant within Product Management team. He applies his detailed knowledge of pharmaceutical processes and documentation to the areas of business process analysis, optimization of software solutions and demonstration of their capabilities. He started his professional career at Pliva (now the TEVA Group), where in addition to his responsibilities in manufacturing, he engaged in a successful EDMS implementation project. He later joined KRKA’s Regulatory Affairs Department, and finally moved to Amplexor in 2008. Siniša received his Bachelor of Science degree in Pharmacy from Zagreb University.
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