Events [3]

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

Title			Instructor
	Medical Device Complaints, MDR's and Recalls [4]			John Chapman
	Designing Viral Clearance Studies for Biopharmaceuticals [5]			Kathryn Martin Remington - Senior Manager of Virology, Cardinal Health
	Common Problems and Mistakes in Method Validation in drug development process [6]			Dr. Wise Blackman - Senior Manager, Cellular Technologies, Cardinal Health
	Pharmaceutical Manufacturing Process Validation [7]			Rodney E Thompson - Founder and President, Process Associates
	Best Practices in 510(k) Submissions [8]			William G Mclain - President, Keystone Regulatory Services, LLC
	How to set up a small-volume radiopharmaceuticals manufacturing facility [9]			Shankar Seetharaman
	Viral Validation for Bio-pharmaceuticals [10]			Kathryn Martin Remington - Senior Manager of Virology, Cardinal Health
	FDA's Current Thinking for Industry cGMPs for Phase 1 INDs [11]			Sandra N. Whetstone, Expert, US Food and Drug Law
	Designing Regulatory - Compliant Clinical Research Data Management Systems [12]			Dale Hunscher - Senior Systems Analyst, Michigan Institute for Clinical and Health Research
	Validation of Bioanalytical Assays for Biologicals [13]			Ana Menendez - Senior Director, Bioassays and Biosafety Testing, Cardinal Health
	FDA's Expectations for cGMPs for Analyst/Process Chemists [14]			Sandra N. Whetstone - Expert, US Food and Drug Law
	Implementing Process Controls for Optimum Performance of Cell-Based Assays [15]			Dr. Wise Blackman - Senior Manager, Cellular Technologies
	Validation of Potency Bioassays for Biologicals [16]			Ana Menendez - Senior Director, Bioassays and Biosafety Testing, Cardinal Health
	Effective Method Transfer of Complex Bioassays [17]			Ana Menendez - Senior Director, Bioassays and Biosafety Testing, Cardinal Health
	Complying with 21CFR Part 11-Understanding the Role of Predicate Rules [18]			Tony Dunbar - Senior Compliance Consulting Expert