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On 26 January 2022, representatives of the author team for the ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry held a webinar to provide an...
Stephanie A. Friedrichsen
Eli Lilly & Co
Associate Director - CCI Coach
Steph Friedrichsen joined Eli Lilly & Company in 2008 as part of PR&D’s Clinical Trial QA group, where she was the process owner for collaboration partner qualification, ongoing oversight, and activities such as person in plant and metrics. In 2015, she transitioned to the Global Serialization Program where she is responsible for the strategic plan for knowledge management, training strategy, and lean six sigma projects and applications within Global Packaging & Robotics. Steph has previously spoken at APQC’s KM Conference on the application of KM to Lilly’s serialization project and at IFPAC on behalf of the BPOG KM workstream. In 2021, Steph was the IFPAC KM session co-chair and member of the ISPE KM Good Practice Guide author team.
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iSpeak Blog
Knowledge Management (KM) is a discipline (akin to Quality Risk Management (QRM) or Lean Six Sigma) that focuses on how organizations create, manage, use, and share knowledge. The publication of ICH Q10 in 2008 saw the formal designation of KM as a key enabler for an effective Pharmaceutical Quality System (PQS), along with QRM. Since then, the industry has acknowledged the...