Web seminars for FDA regulated industries available as o­n Demand and CD version

Title			Instructor
	Medical Device Complaints, MDR's and Recalls			John Chapman
	Designing Viral Clearance Studies for Biopharmaceuticals			Kathryn Martin Remington - Senior Manager of Virology, Cardinal Health
	Common Problems and Mistakes in Method Validation in drug development process			Dr. Wise Blackman - Senior Manager, Cellular Technologies, Cardinal Health
	Pharmaceutical Manufacturing Process Validation			Rodney E Thompson - Founder and President, Process Associates
	Best Practices in 510(k) Submissions			William G Mclain - President, Keystone Regulatory Services, LLC
	How to set up a small-volume radiopharmaceuticals manufacturing facility			Shankar Seetharaman
	Viral Validation for Bio-pharmaceuticals			Kathryn Martin Remington - Senior Manager of Virology, Cardinal Health
	FDA's Current Thinking for Industry cGMPs for Phase 1 INDs			Sandra N. Whetstone, Expert, US Food and Drug Law
	Designing Regulatory - Compliant Clinical Research Data Management Systems			Dale Hunscher - Senior Systems Analyst, Michigan Institute for Clinical and Health Research
	Validation of Bioanalytical Assays for Biologicals			Ana Menendez - Senior Director, Bioassays and Biosafety Testing, Cardinal Health
	FDA's Expectations for cGMPs for Analyst/Process Chemists			Sandra N. Whetstone - Expert, US Food and Drug Law
	Implementing Process Controls for Optimum Performance of Cell-Based Assays			Dr. Wise Blackman - Senior Manager, Cellular Technologies
	Validation of Potency Bioassays for Biologicals			Ana Menendez - Senior Director, Bioassays and Biosafety Testing, Cardinal Health
	Effective Method Transfer of Complex Bioassays			Ana Menendez - Senior Director, Bioassays and Biosafety Testing, Cardinal Health
	Complying with 21CFR Part 11-Understanding the Role of Predicate Rules			Tony Dunbar - Senior Compliance Consulting Expert