• Regulatory / Compliance Issues for Bioreactor Design and Operations

• Environmental Monitoring Considerations

• PAI Preparation --- A Model

• Recent PAI Experiences

• Failure Investigations, Inspector’s Expectations

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• Current Regulatory Issues in Facilities Design; Don Hill, University of Maryland at Baltimore, April 2005.
  
  

• Failure Investigations-Industry Perspective; Brian Neely, 5th Annual FDA and the Current Challenges of GMPs Conference, July 2003
  
  

• Using a Model and Tools to Standardize the Preparation for a Preapproval Inspection; Barbara W. Unger, BioPharm February 2002
  
  
• Preparing Biological Product Deviation Reports ; Barbara W. Unger, BioPharm, October 2002
  
  

Don Hill & Associates, Inc
Main Office (301) 260-2200   Fax (301) 260-2020
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