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Risk-Based Approaches for Validating Enterprise Share Point Deployment in FDA-Regulated Environments Speaker: Daniel O’Connor, Innovocommerce LLC Date: Jan.

18, 2011 Description: This Webinar by Daniel O’Connor, Co-Founder, Innovo Commerce LLC, will introduce innovative best practice risk-based approaches to validating enterprise Microsoft Share Point deployments in FDA regulated environments.

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top 8.20 Chairman’s Opening Remarks Dr Kai Juergens, Senior Project Manager External Manufacturing, Bayer Pharma AG, Germany 8.30 Process Validation Review During Regulatory Inspections • Process validation definition and regulatory expectations • General considerations on process validation throughout the lifecycle • How to approach CPV • Observations reported during various regulatory inspections • Maintaining audit readiness with respect to Process Validation M.

KG, Germany 14.40 CPV Challenges with Outsourcing • Risks and benefits of outsourcing with regard to CPV • The manufacturer’s policy as framework • Definition of critical process paramaters • How to deal with legacy products • Challenges with the handover to external manufacturing partners Dr Kai Juergens, Senior Project Manager External Manufacturing, Bayer Pharma AG, Germany 15.30 Networking and Coffee Break 16.00 CPV in Practice – a Quality by Design Point of View • Development of a risk based control strategy • Measuring of product and process performance • Continuous evaluation of control strategy and feedback loops/revalidation • CPV and Validation Maintenance • CPV reporting - Dashboards • CPV in CMO collaborations Gabriele Gold, Head of Quality by Design, Process Development & Technical Services, Shire, Austria 16.50 SPC as Part of Continuous Validation • How can SPC be used in practice?

• SPC as proof of continuous validation • Process development, re-evaluation und definition of parameters • Challenges regarding the process performance validation approach Dr Per Vase, Managing Partner, Applied Manufacturing Science, NNE Pharmaplan, Denmark 17.40 Closing Remarks 18.30 Evening Reception Following the official part of the conference, Chem-Academy invites you to a social evening reception at an atmospheric local restaurant.

The presentation begins with a high level introduction to Share Point enterprise planning and deployment considerations for life science organizations that will consider use of validated applications.

legacy products Dr Philip Hoersch, Director QA - Validation/Risk Management/Trending, Vetter Pharma-Fertigung Gmb H & Co.Many Share Point users, however, find that the system lacks sufficient document control, training, and other business process automation capabilities.

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