Richard Chamberlain speaker of compliance global

Speaker: Richard Chamberlain
Duration: 60 Minutes
Product ID: 700050

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IRB and Other Committees for Smooth Clinical Trial Conducts

This webinar will introduce the participants to some of the committees that are involved or are necessary for the conduct of  clinical trials. The IRB process will normally decide if the trial more...

Richard Chamberlain speaker of compliance global

Speaker: Richard Chamberlain
Duration: 90 Minutes
Product ID: 700065

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Implementing 21 CFR Part 11 - What is Computer Systems Validation and how to Implement it.

This system validation webinar training by the expert speaker will cover the Computer Systems Validation Regulations and then cover how a company complies with those regulations when they implement more...

Sarah Fowler-Dixon speaker of compliance global

Speaker: Sarah Fowler-Dixon
Duration: 60 Minutes
Product ID: 700287

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10 Tips for Submitting Human Subjects Protocols

Institutional Review Boards (IRB) also known as ethics committees or ethical review boards were established by federal regulation in 1974. IRBs are independent committees designated to approve, mon more...

Sarah Fowler-Dixon speaker of compliance global

Speaker: Sarah Fowler-Dixon
Duration: 60 Minutes
Product ID: 700324

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Federal wide Assurances: What are they; why and when do I need them?

The Federal Wide Assurance requires written agreements with non-affiliated investigators. These agreements are assurances under which a research study will be conducted. The Federal wide As more...

Sarah Fowler-Dixon speaker of compliance global

Speaker: Sarah Fowler-Dixon
Duration: 60 Minutes
Product ID: 700468

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New Part 11 Guidance for Clinical Trials: What This Means for You

FDA regulations related to Good Clinical Practices includes Electronic Medical Records and Electronic Signatures. Governing those is 21 CFR Part II. The Department of Health and Human Service equiv more...

Sarah Fowler-Dixon speaker of compliance global

Speaker: Sarah Fowler-Dixon
Duration: 60 Minutes
Product ID: 700423

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What is a Serious Adverse Events and how do I handle these?

Serious adverse events along with their cousins, serious adverse reactions, anticipated events, unanticipated events and unanticipated problems are often confused and misunderstood. more...

Carolyn Troiano speaker of compliance global

Speaker: Carolyn Troiano
Duration: 90 Minutes
Product ID: 700514

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Trial Master File (TMF): FDA Expectations from Sponsors and Sites.

Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be store more...

Sarah Fowler-Dixon speaker of compliance global

Speaker: Sarah Fowler-Dixon
Duration: 60 Minutes
Product ID: 700507

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Deviations: What are they? Do you need to report?

Deviations have often been misunderstood, misclassified, and misreported. Adding to the confusion is terminology that has been applied to deviations, leaving the study team, the study monitors, and more...

Rebecca Zapatochny-Rufo speaker of compliance global

Speaker: Rebecca Zapatochny-Rufo
Duration: 60 Minutes
Product ID: 700339

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Safety Issues Associated with Electronic Health Records Integration

As a result of the American Reinvestment & Recovery Act in 2009, the integration of the electronic health record system (EHR) revolutionized the documentation of patient care. The expectations more...