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Phase 1 Compliance

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This Presentation was given at MichBio\'s Annual Expo. It discusses the guidance for Phase 1 compliance.

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Phase 1 - Compliance Presented By: John Wichelt ProPharma Group November 4, 2009 2009
Presentation Overview ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],2009
Introduction ,[object Object],[object Object],[object Object],[object Object],2009
Guidance Objectives ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],2009
Regulatory Requirements ,[object Object],[object Object],2009
Guidance Scope ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],2009
General Requirements ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],2009
Personnel and QC ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],2009
Facility and Equipment ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],2009
Manufacturing and Records ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],2009
Laboratory Controls ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],2009
Packaging, Labeling and Distribution ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],2009
Example Utility Controls ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],2009
Example Equipment Controls ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],2009
Example Manufacturing Environment Controls ,[object Object],[object Object],[object Object],[object Object],[object Object],2009
Thank You! John Wichelt Sr. Project Manager ProPharma Group www.propharmagroup.com 2009
References ,[object Object],[object Object],[object Object],[object Object],2009

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Phase 1 Compliance

  • 1. Phase 1 - Compliance Presented By: John Wichelt ProPharma Group November 4, 2009 2009
  • 2.
  • 3.
  • 4.
  • 5.
  • 6.
  • 7.
  • 8.
  • 9.
  • 10.
  • 11.
  • 12.
  • 13.
  • 14.
  • 15.
  • 16. Thank You! John Wichelt Sr. Project Manager ProPharma Group www.propharmagroup.com 2009
  • 17.