Good Clinical Web-based Seminars

Clinical Research Associate ( CRA ) and Clinical Research Coordinator ( CRC ) Online Training Program The content of the Clinical Research Associate and Coordinator Training Program covers the Good Clinical Practice (GCP), the FDA and Health Canada regulations, the ICH Guidelines and gives numerous checklists and tips how to meet the job responsibilities. The course provides all the necessary information needed to be a successful Clinical Research Associate or Clinical Research Coordinator. The  more...

Personalized Online Clinical Research Training for Clinical Research Professionals The content of the Online Training Program covers the Good Clinical Practice (GCP), the FDA and Health Canada regulations, the ICH Guidelines and gives numerous checklists and tips how to meet the job responsibilities. The course provides all the necessary information needed to be a successful Clinical Research Professional. The course can be personalized so that it fits your requests.  more...

Key Aspects of the Trial Master File and How to Pass FDA Inspection - Webinar By GlobalCompliancePanel This presentation will help with preparing the site and the study team with how to successfully prepare for an audit, how to identify risk of noncompliance, what to do before, during and after an audit. All these are done with the primary goal in mind: getting no audit findings. Thursday, November 3, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Understanding and Implementing FDAs 21 CFR Part 11 - Webinar By GlobalCompliancePanel In 1997 the US FDA issued a regulation that provides criteria for acceptance by the FDA of electronic records, electronic signatures and handwritten signatures. The rule applies to all industry segments regulated by the FDA that includes Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP). Even though the rule is more than 10 years old  more...

The GCPICH Obligations of Sponsors Monitors and Investigators - barriers and solution - Webinar By GlobalCompliancePanel ... investigator sites. See how compliance with the Regs and Good Clinical Practice will ensure quality data, speed up the review process, and decreases the costs to sponsors. This Webinar addresses the obligations of sponsors, monitors, and investigators who conduct and verify clinical research that is governed by US FDA regulations and ICH guidelines. Why Should You Attend: All CROa ™s,  more...

Defining and Managing Protocol DeviationViolationException - Webinar by GlobalCompliancePanel As the purpose of a clinical trial is to determine safety and effectiveness of a treatment, it is imperative that the rules of the trial be followed exactly. If there are Instances of "Protocol Not Followed" (PNF), that could result in a failure to determine safety and effectiveness. That is why eligibility criteria are so strict, and why any PNF or unexpected events need to be reported  more...

The FDA Tripod - Clinical Trial Regulations Compliance and GCP in Drug Development - Webinar by GlobalCompliancePanel ...Good Clinical Practice (GCP) and FDA regulations and requirements. Participants receive a foundation of knowledge about GCP, practical examples, and the underlying scientific and regulatory principles involved. Guidelines for each aspect of research are provided, as well as information on the structuring and preparation of protocols, consent forms, and investigator brochure. Information on  more...