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Organization of Regulatory and Clinical Associates
Meeting Presentation Archive
- ORCA July 22, 2010 Meeting Presentation: FDA Update (1.1 mb PDF)
- ORCA May 18, 2010 Meeting Presentation: Best Practices for Complaint Managemen (310 kb PDF)
- ORCA April 14, 2010 Meeting Presentation: Adaptive Clinical Trial Design & Electronic Data Capture (470 kb zip)
- ORCA March 16, 2010 Meeting Presentation: Management Controls (241 kb zip)
- ORCA February 24, 2010 Meeting Presentation: RISK Management Drugs and Biologics (323 kb PDF)
- ORCA December 9, 2009 Meeting Presentation: Developing and Managing CRO Relationships (335 kb PDF)
- November 19, 2009 Meeting Presentation: Developing and Managing CRO Relationships (803 kb PDF File)
- August 12, 2009 - Meeting Presentation, P. Y. Liu, Ph.D., (Powerpoint 330 kb)
- July 9, 2009 - Meeting Presentations (Zip file)
- January 14, 2009 - Meeting Slides: Risk Management Processes & Tools to Know (PDF 280 kb)
- May 5, 2009 - Meeting Handouts, FDA Enforcement Updates (PDF 214 kb)
- February 13, 2009 - Meeting Handouts, Non-clinical Consierations for Pharma Development (PDF 1.0 mb)
- November 19, 2008 - Meeting Slides: Physician's Labeling (PDF 417 kb)
- August 6, 2008 - Meeting Handouts, Lean Six Sigma in Pharmaceutical and
Biotech Manufacturing and R&D (PDF 1.1 mb)
- July 16, 2008 - Meeting Presentation, FDA Updates (Powerpoint 64 kb)
- January 16, 2008 - Meeting Presentation, Critical Changes in US and EU
Regulations and Guidance (PDF 172 kb)
- November 9, 2007 - Meeting Handouts, Workshop on International Medical Device Reporting Requirements (PDF 858 kb)
- October 17, 2007 - Meeting Handouts, Managing IT Regulatory Requirements (PDF 1.5 mb)
- August 8, 2007 - Meeting Presentation, Trials in Russia & Central Europe (PDF 734 kb)
- June, 2007 - Meeting Handouts, Expanding Implementation of ISO 14971 Development (pdf 226 kb)
- February, 2007 - Meeting Presentation, Quality System Integration (PDF kb)
- April, 2006 - Meeting Presentation, Bruce Haggar, CAPA, An Integrated Approach (PDF 647 kb)
- August 20, 2003 - Meeting Presentation, Carol L. Sangster, Introduction to Business Continuity Planning (Powerpoint 1.1 mb)
- FMEA Risk Analysis Example (PDF 17 kb)
- FTA Risk Analysis Example (PDF 14 kb)
- RM Flow (PDF 12 kb)
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