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Tuesday, June 28 • 4:00pm - 5:15pm
#270: Implementing Knowledge Management: Industry Perspectives

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Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

This session will discuss how knowledge management is a pivotal systematic element of life cycle management. The use of prior knowledge in risk assessments in the design, development, and maintenance of product quality as well as the justification for changes is predicated on robust knowledge management systems that integrate information and data from multiple sources.

Learning Objectives

Discuss the role knowledge management plays in the design, development, and maintenance of product quality.

Chair

Paige Kane

Speaker

Think Big but Start Small: The Evolution of Knowledge Management at a Large Pharmaceutical Company
Jodi Schuttig, MBA

CMC Data Readiness and Future Proofing for IDMP
Kim S. Northam

Why Wonder When You Can Know?
James Roberts, PhD



Chair
avatar for Paige Kane

Paige Kane

Regulatory Science Researcher/ Director KM CoE, Dublin Institute of Technology/ Merck & Co., Inc.
Paige Kane, CPIP, is the Director of Knowledge Management Pfizer Global Supply/ Global Technology Services. Ms. Kane is responsible for developing and implementing the Knowledge Management Strategy for Pfizer Global Supply (PGS) with a strong focus on people, processes and collaboration. Ms. Kane has been leading the Knowledge Management strategy at Pfizer/Wyeth for the last 8 years and has over 25 years’ experience working in a regulated... Read More →

Speakers
avatar for Kim Northam

Kim Northam

Manager, Regulatory Affairs, Accenture Accelerated R&D Services
Kim has ten years’ experience in CMC and has managed various projects from complex in licencing activities, to compliance and remediation, and also process transformations. Through her tenure at Accenture Kim has helped companies improve their CMC data management ensuring timely accessibility of registered information to facilitate product release. Before joining Accenture, Kim worked in industry at a top ten Pharma company. Kim holds a... Read More →
avatar for James Roberts

James Roberts

Head, Platform Analysis, GlaxoSmithKline
James Roberts leads a team of scientists, engineers and compliance experts to embed data integrity, data quality and compliance into analytical testing processes in real-time. He founded Allotrope Foundation in 2012 with colleagues from other pharma companies and is using the Allotrope Framework to embed data standards into the measurement process. Prior to joining GSK, he worked at Pfizer as an analytical chemist in early development. He has a... Read More →
avatar for Jodi Schuttig

Jodi Schuttig

Director, Knowledge Management, Merck & Co., Inc.
Jodi Schuttig, Director of Knowledge Management in the Merck Manufacturing Division, has over 25 years of experience in the phar¬maceutical sector through various roles at Merck. Jodi holds a B.S. in Mechanic Engineering and a M.B.A. in Business Administration. In 2013 Jodi joined the Merck Manufacturing Division (MMD) Knowledge Management Center of Excellence in support of the expansion of KM for all of manufacturing and key partner groups... Read More →


Tuesday June 28, 2016 4:00pm - 5:15pm
111AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA