Realize the Power of Knowledge
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- Ernest Rudolf Potter
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1 Realize the Power of Knowledge PDA Task Force on PCMO Sec. 2.1 Capture Knowledge Management during Commercial Manufacturing VisionPharma 2013, Karlsruhe 6. Februar 2013 Thomas Peither, Maas & Peither AG, PEITHER Consulting Halfmann Goetsch Peither AG Acknowledgements PCMO Task Force Sec. 2.1 Capture Knowledge Management during Commercial Manufacturing Chris Smalley (chair) Jim Seely Paul G. Ellis Ursula Busse Cliff Campbell Kathleen Green Taiichi Mitzuta Lara Collier Jill Peirick Chenk Undey Josef Horvath Jeff Torres Christa Hartmann Betzy Castilla Eoin Harrington , Thomas Peither, Maas & Peither AG, Schopfheim, Germany Thomas Peither, Schopfheim 1
2 What is Knowledge? , Thomas Peither, Maas & Peither AG, Schopfheim, Germany Knowledge Definition Oxford English Dictionary defines Knowledge as: expertise, and skills acquired by a person through experience or education; the theoretical or practical understanding of a subject , Thomas Peither, Maas & Peither AG, Schopfheim, Germany Thomas Peither, Schopfheim 2
3 Knowledge Management Definition ICH Q10 Pharmaceutical Quality System Knowledge Management is a systematic approach to acquiring, analyzing, storing, and disseminating information related to products, manufacturing processes and components. Knowledge Management = Enabler of the Quality System Without knowledge management the improvement of processes will be very difficult , Thomas Peither, Maas & Peither AG, Schopfheim, Germany Goal , Thomas Peither, Maas & Peither AG, Schopfheim, Germany Thomas Peither, Schopfheim 3
4 Online Survey April 2011 ICH Q10 references Knowledge Management (KM) as enabler for the implementation of a state-of-the-art pharma quality system. Do you already cover this topic in your company? No, this is no issue in our company 32% Yes, we have a responsible person for the implementation 14% Yes, we discuss how we shall implement KM 24% Yes, we think about that 30% , Thomas Peither, Maas & Peither AG, Schopfheim, Germany ICH Q10 Pharmaceutical Quality System , Thomas Peither, Maas & Peither AG, Schopfheim, Germany Thomas Peither, Schopfheim 4
5 From Data to Knowledge Data Information Knowledge , Thomas Peither, Maas & Peither AG, Schopfheim, Germany Data Information - Knowledge Context Experience Data Information Knowledge Wisedom Research Creation Gathering Discovery Presentation Organization Storytelling Integration Contemplation Evaluation Interpretation Retrospection , Thomas Peither, Maas & Peither AG, Schopfheim, Germany Thomas Peither, Schopfheim 5
6 Structure of PDA Techn. Report Chapter 1 Introduction Chapter 2 Create and Gather Data Chapter 3 Present and Organized Information Chapter 4 Share and Integrate Knowledge Chapter 5 Understand and Apply Wisdom Chapter 6 Implement Successful System , Thomas Peither, Maas & Peither AG, Schopfheim, Germany What is Knowledge Management Decision making Data Information Knowledge Understanding Raw facts are the base for KM processes Filtering process put facts into context Options give guidance for actions Learning what to use for what purpose , Thomas Peither, Maas & Peither AG, Schopfheim, Germany Thomas Peither, Schopfheim 6
7 KM Function Model 1. Acquisition of data 2. Data evaluation 3. Filtering of information 4. Understanding of information to understand the product/process 5. Review process of knowledge 6. Storage & sharing of knowledge 7. Improving of knowledge base , Thomas Peither, Maas & Peither AG, Schopfheim, Germany What is Knowledge Management Decision making Data Information Knowledge Understanding Raw facts are the base for KM processes Filtering process put facts into context Options give guidance for actions Learning what to use for what purpose , Thomas Peither, Maas & Peither AG, Schopfheim, Germany Thomas Peither, Schopfheim 7
8 1. Acquisition of Data Manufacturing Execution Systems (MES) Laboratory Information Mgmt. Systems (LIMS) Process Analytical Technology (PAT) Annual Product Review/Product Quality Review Batch Records Monitoring data , Thomas Peither, Maas & Peither AG, Schopfheim, Germany 2. Data Evaluation Transform raw data into useful information Use helpful tools & procedures: Six Sigma Statistical tools Quality by Design , Thomas Peither, Maas & Peither AG, Schopfheim, Germany Thomas Peither, Schopfheim 8
9 Why? Highly efficient Highly profitable Highly mature , Thomas Peither, Maas & Peither AG, Schopfheim, Germany Quote Knowledge in the minds of enterprise members is the most valuable organizational resource, which cannot be left unmanaged. Jay Liebowitz, , Thomas Peither, Maas & Peither AG, Schopfheim, Germany Thomas Peither, Schopfheim 9
10 Kontakt Maas & Peither AG Karlstrasse Schopfheim (bei Basel) thomas.peither@gmp-publishing.com PEITHER Consulting Thomas Peither Vorstand Principal Consultant Karlstrasse Schopfheim (bei Basel) tp@peither.com , Thomas Peither, Maas & Peither AG, Schopfheim, Germany Thomas Peither, Schopfheim 10
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