Scheduled Training Courses

Training NameSpeakerTraining LevelTraining Options View Details
Excel Spreadsheets: Applying 21 CFR Part 11 compliance Richard Chamberlain Intermediate
Live, Thu, Apr 06, 2017
OnDemand Recording
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21 CFR Part 11 and Annex 11 Compliance; specifics needed to eliminate 483s Richard Chamberlain Intermediate
Live, Thu, Apr 27, 2017
OnDemand Recording
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FDA Clinical Trial Project Management Richard Chamberlain Intermediate
Live, Tue, May 09, 2017
OnDemand Recording
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How has the rapid growth of low-cost wearable health monitors, such as those worn on the wrist or clothing, changed data collection in clinical trials Sarah Fowler-Dixon Intermediate
Live, Tue, May 23, 2017
OnDemand Recording
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What exactly is required for 21 CFR Part 11 compliance Richard Chamberlain Intermediate
Live, Thu, May 25, 2017
OnDemand Recording
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Federalwide Assurances: What are they; why and when do I need them? Sarah Fowler-Dixon Intermediate
Live, Thu, Jun 08, 2017
OnDemand Recording
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The Sunshine Act: Reporting for Clinical Trials Sarah Fowler-Dixon Intermediate
Live, Fri, Jul 07, 2017
OnDemand Recording
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6-hr Virtual Seminar: FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials Karl M. Nobert Intermediate
Live, Coming Soon..
OnDemand Recording
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Adverse Event Reporting (Drug) Azita Ahmadi Intermediate
Live, Coming Soon..
OnDemand Recording
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Pharmaceutical Compressed Air - Quality GMP Standards and Requirements Roger Cowan Intermediate
Live, Coming Soon..
OnDemand Recording
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Documentation Improvement: 7 Criteria for High Quality Clinical Documentation Dorothy Steed Intermediate
Live, Coming Soon..
OnDemand Recording
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SOPs for Clinical Trials – Regulatory Requirements and Key to Effective Management Harold Thibodeaux Intermediate
Live, Coming Soon..
OnDemand Recording
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The Value of laboratory and cardiogram data on subject Safety: What have we learned? Dr. Charles Pierce, Intermediate
Live, Coming Soon..
OnDemand Recording
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Should Pharmacovigilance Start Much Earlier than Phase IV (Postmarket Surveillance) Dr. Charles Pierce, Intermediate
Live, Coming Soon..
OnDemand Recording
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Adverse Event Reporting: Understanding Regulatory Reporting Requirements when Adverse Drug Reactions (i.e. Adverse Events) occur at the investigational stage of a Clinical Trial Nicole Tesar Intermediate
Live, Coming Soon..
OnDemand Recording
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How Due Diligence in Accurate Adverse Event Reporting is the Key to a clean FDA Site Inspection/Audit and how to avoid them. Dr. Charles Pierce, Intermediate
Live, Coming Soon..
OnDemand Recording
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Internal Auditing – What you need to know Marie Dorat Intermediate
Live, Coming Soon..
OnDemand Recording
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Critical SOPs for Clinical Sites Mukesh Kumar Intermediate
Live, Coming Soon..
OnDemand Recording
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Clinical Trial Monitoring – What is Required? Marie Dorat Intermediate
Live, Coming Soon..
OnDemand Recording
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International Conference on Harmonization Good Clinical Practice Guidelines (ICH GCP) Christine Hegi Intermediate
Live, Coming Soon..
OnDemand Recording
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10 Steps to an FDA-Acceptable Clinical Trial Protocol Mukesh Kumar Intermediate
Live, Coming Soon..
OnDemand Recording
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Negotiating Clinical Trial Contracts in a Minefield: The Stark Rule, Anti-kickback Statue, False Claims Act and Medicare Secondary Payer Rule Robert (Bob) Romanchuk Intermediate
Live, Coming Soon..
OnDemand Recording
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Informed Consent – A Process Not a Piece of Paper Christine Hegi Intermediate
Live, Coming Soon..
OnDemand Recording
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Clinical Trial Billing - Building a Compliant Process that Works! Robert (Bob) Romanchuk Intermediate
Live, Coming Soon..
OnDemand Recording
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ICH-FDA Good Clinical Practice – Managing Clinical Trials Marie Dorat Intermediate
Live, Coming Soon..
OnDemand Recording
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