Scheduled Training Courses

Training NameSpeakerTraining LevelTraining Options View Details
Demonstrated Techniques to a Successful 510k Submission Mercedes Massana Intermediate
Live, Thu, Mar 30, 2017
OnDemand Recording
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Achieving Compliance with Robust CAPA Systems Danielle DeLucy Intermediate
Live, Fri, Mar 31, 2017
OnDemand Recording
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Trial Master File (TMF): FDA Expectations from Sponsors and Sites Sarah Fowler-Dixon Intermediate
Live, Fri, Apr 07, 2017
OnDemand Recording
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How to Write and Manage a Change Control System Danielle DeLucy Intermediate
Live, Mon, Apr 10, 2017
OnDemand Recording
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3 Hr Virtual Seminar : China: Compliance Processes for Life Science Products: Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations Robert J. Russell Intermediate
Live, Fri, Apr 14, 2017
OnDemand Recording
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Surviving an FDA Inspection: Understand the Do's and Don'ts and the Ground Rules David R. Dills Intermediate
Live, Tue, Apr 18, 2017
OnDemand Recording
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Process Reliability Modeling: Measure the Cause Not the Effect of Process Variation Dr. Michael Abitz Intermediate
Live, Thu, Apr 20, 2017
OnDemand Recording
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Understanding Aseptic Technique and Cleanroom Behavior Danielle DeLucy Intermediate
Live, Mon, Apr 24, 2017
OnDemand Recording
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Getting Ready for an FDA Inspection Felicia Angus Intermediate
Live, Tue, Apr 25, 2017
OnDemand Recording
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Understanding and Implementing a Quality by Design Program Steven Laurenz Intermediate
Live, Fri, Apr 28, 2017
OnDemand Recording
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6-hr Virtual Seminar: Managing FDA’s Tougher Import Requirements Concerning International Consequences by Ex-FDA Official Casper Uldriks Intermediate
Live, Tue, May 02, 2017
OnDemand Recording
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Good Documentation Practices Danielle DeLucy Intermediate
Live, Fri, May 12, 2017
OnDemand Recording
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Understanding and Implementing a Technology Transfer Process Steven Laurenz Intermediate
Live, Fri, May 12, 2017
OnDemand Recording
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How FDA Trains Its Investigators to Review CAPA, and What You Can do to Prepare Jeff Kasoff --
Live, Wed, May 17, 2017
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3-hr Virtual Seminar: Japan Regulatory Compliance Requirements for Life Science Products Robert J. Russell Intermediate
Live, Thu, May 25, 2017
OnDemand Recording
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Best Practices for Investigating Deviations Danielle DeLucy Intermediate
Live, Fri, May 26, 2017
OnDemand Recording
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Best Practices in Document Approval, Control and Distribution Jeff Kasoff Intermediate
Live, Tue, May 30, 2017
OnDemand Recording
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Critical Elements of Quality Risk Management Relating to FDA Compliance Danielle DeLucy Intermediate
Live, Wed, Jun 14, 2017
OnDemand Recording
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Implementing a Change Control Quality System Successfully Danielle DeLucy Intermediate
Live, Thu, Jun 29, 2017
OnDemand Recording
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Best Practices in Document Approval, Control and Distribution Jeff Kasoff Intermediate
Live, Tue, May 30, 2017
OnDemand Recording
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Mitigating the Detrimental Economic Impact of Generic Drugs – Strategies for Marketing and Selling an Authorized Generic in the U.S Karl M. Nobert Intermediate
Live, Coming Soon..
OnDemand Recording
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Raw Materials Risk Management in GMP Facilities John E. Lincoln Intermediate
Live, Coming Soon..
OnDemand Recording
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3-hr Virtual Seminar: Equipment Qualification and Validation of Processes in the Manufacturing Environment Joy L. McElroy Intermediate
Live, Coming Soon..
OnDemand Recording
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Good Documentation Practices to Support FDA-Regulated Computer System Validation Carolyn Troiano Intermediate
Live, Coming Soon..
OnDemand Recording
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How to Properly Manage a Regulatory Inspection Danielle DeLucy Intermediate
Live, Coming Soon..
OnDemand Recording
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