Teleconference Audio CDs presented by Mark Elengold
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FDA's 2011 Guidance on Process Validation: General Principles & Practices
-Presented Thursday, February 24, 2011 • 1:00pm – 2:30pm EST (GMT -5) by Mark Elengold.
Finding What Is (and Isn't) on FDA's Website
-Presented November 16, 2010 by Mark Elengold.
Threat or Opportunity? Biosimilars: Implementing Section 7002.
-Presented September 28, 2010 by Mark Elengold.
GMP 101: An Introduction to Current Good Manufacturing Practice Requirements.
-Presented July 29, 2010 by Mark Elengold.
Dealing with "No!" (or Endless Questions) from FDA
-Presented July 15, 2010 by Mark Elengold.
Approval of Biosimilars & FDAs Implementation of Section 7002: What Does it Mean to YOU?
-Presented June 3, 2010 by Mark Elengold.
Avoiding Statistical Errors in Clinical Trials: Preparing for FDA Review
-Presented April 8, 2010 by Mark Elengold.
FDA Meetings: An Examination of Benefits & Risks
-Presented April 6, 2010 by Mark Elengold.
What's Next for FDA's cGMPs?
-Presented March 23, 2010 by Mark Elengold.
Teleconference Audio CD: FDA's International Programs
-Presented March 16, 2010 by Mark Elengold.
The FDA Inspection is Over...What Do I Do Now?
-Presented February 17, 2010 by Mark Elengold.
What does the Janitor Need to Know? Preparing Everyone Else for an FDA Inspection
-Presented February 4, 2010 by Mark Elengold.
The FDA Bioresearch Monitoring Program (BiMo)
-Presented January 28, 2010 by Mark Elengold.
GMP Update - Current Issues in Good Manufacturing Practices
-Presented October 15, 2009 by Mark Elengold.
Finding What is (and What isn't) on FDAs Revised Website
-Presented September 17, 2009 by Mark Elengold.
Who Regulates My Product (and Why)?
-Presented August 4, 2009 by Mark Elengold.
FDA, a New Administration, & a New Congress: Potential Changes & Avoiding Problems
-Presented January 29, 2009 by Mark Elengold.
The FDA Bioresearch Monitoring Program (BiMo)
-Presented December 4, 2008 by Mark Elengold.
What NOT to Do! The Top Ten Mistakes Companies Have Made
-Presented October 2, 2008 by Mark Elengold.
The FDA Bioresearch Monitoring Program (BiMo)
-Presented March 4, 2008 by Mark Elengold.
FDA Inspections: Who, What, Why, When & How?
-Presented February 7, 2008 by Mark Elengold.
Through A Crystal Ball: Whats Next For The FDA (And Regulated Industry)?
-Presented October 11, 2007 by Mark Elengold.
The FDA Foreign Inspection Program
-Presented September 11, 2007 by Mark Elengold.
Internal FDA Information
-Presented August 10, 2006 by Mark Elengold and a panel of experts.