Quality Management of the Next Decade – Journey to 2030 

18 November 2020 | Online

Catch the latest updates on staying compliant with regulatory requirements all whilst staying up-to-date with the shift from the classic monolithic document-centric approach to a data-driven and structured environment for the future.

The complexity of everyday operations in the life sciences industry is continuously rising. To keep up with the regulatory requirements while maintaining the quality, efficacy, and safety of their products in focus, companies are required to constantly re-visit their approach to processes, technology, and information. Staying flexible and agile is the key to implementing a smooth transition from a monolithic document-centric approach to a data-driven and structured methodology.

In this webinar, we’ll explore 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. We’ll also cover how to manage process dependencies (from a deviation, through CAPA, over change management all the way to variation submission).

Join us as Siniša Belina, Amplexor's Senior Life Sciences Consultant, will present the impact of the EU IDMP Implementation Guide on the Amplexor Life Sciences Suite. He will demonstrate the implementation of the required IDMP data fields as part of the ProductExpert solution as well as discuss what processes need to be in place to comply with the TOM within the RIMExpert solution.

Meet the Speakers

Siniša Belina

Senior Life Sciences Consultant at Amplexor 

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.

Alexander Tryba

Managing Partner at 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).