Quality Management of the Next Decade – Journey to 2030

Although everyday operations in the Life Sciences world is becoming ever so more complex, there are ways in which you can keep up with regulatory requirements.


About the webinar

Watch our webinar for tips on how to maintain quality, efficacy and safety of the products at hand.

In this session, you’ll learn about:

  • The potential and opportunities of implementing integral quality management platforms
  • How to merge them into the comprehensive process that includes R&D, manufacturing, regulatory and labeling
  • How to manage process dependencies
  • …and more
About the speakers
Agnes Cwienczek

Agnes Cwienczek

Senior Life Sciences Consultant, Amplexor

Agnes has been in the position of Senior Life Sciences Consultant for Amplexor since May 2017. In her role as Life Sciences Consultant, Agnes is part of the Product Management team. Her main responsibilities are the contribution to the development and enhancement of the Amplexor Life Sciences Suite, supervision of the Life Sciences Consultants as well as the provision of business process and data management expertise to Amplexor clients in Regulatory Information Management, Document Management, and Submission Management.

Before joining Amplexor, Agnes worked at Merck KGaA in Global Regulatory and Quality Assurance, where she was acting System and Process Owner for all regulatory owned systems, providing global leadership for the management of submission documents, regulatory data and archiving within the Merck Biopharma organization.

Steve Gens

Steve Gens

Managing Partner, Gens & Associates Inc

(MSOD) is the Managing Partner of Gens & Associates Inc., a global Life Science consulting and benchmarking firm specializing in strategic planning, regulatory information management (RIM) program development, industry benchmarking, and organizational performance. His early career was spent at Johnson and Johnson in a variety of management positions and then transitioned to consulting where he led global Life Science consulting practices for First Consulting Group and Booz Allen Hamilton.

His organization is well known for their insightful industry benchmarks, World Class RIM industry performance standard, and thought leadership. Steve has a Bachelor’s of Science in Business Computer Science and a Master in Organizational Development and Performance. He is a frequent speaker, has many publications, and was named to the 2017 PharmaVoice 100 and 2020 R&D Innovations for his contributions to industry.

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