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Good Documentation Practices for Clinical Trials

5939 Candlebrook Ct Ontario

43.6019925 -79.70488030000001

Description

Description :This webinar is intended to help you adequately implement Good Clinical Practices (GCP): in particular, documentation requirements during clinical trials for both drugs and medical devices. To adequately implement GCPs, there are a set of standard operating procedures (SOPs) to be established and maintained at any given facility, to the extent applicable, as a sponsor, clinical investigators, monitors, and CROs, etc. The documentation requirements including a set of SOPs with key elements to be contained in the SOP will be discussed. In this 60-min webinar, you will have unparalleled opportunities to bring great value and benefits to your organization and to greatly improve your GCPs with increased awareness of the needs - sustainable compliance and patient safety.Areas Covered in the Session :Statutes, Regulations and DefinitionsRegulatory Requirements for INDs and IDEs.Clinical TrialsClinical Investigators (CI)Institutional Review Boards (IRBs)Sponsors and MonitorsContract Research Organizations (CROs)ICH-GCP GuidelinesISO 14155List of SOPs and Adequate DocumentationKey Elements in the SOPsCommon GCP Deficiencies in EU and USEnforcement ActionsLessons LearnedWho Will Benefit:Clinical AffairsRegulatory AffairsQuality AssuranceResearch & DevelopmentConsultantsContractors/SubcontractorsSenior ManagementAnyone Interested in the TopicPrice Tags:LiveSingle Live : For One Participant$ 249Corporate Live : For Max. 10 Participants$ 899RecordingSingle REC : For One Participant - Unlimited Access for 6 Months$ 299For more information and enquiries contact us atCompliance Trainings5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada Customer Support : #416-915-4458 Email : support@compliancetrainings.comFor more information about this webinarhttps://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1359Like Us On facebookhttps://www.facebook.com/events/800247606712405/?source=1&sid_create=616533931

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Start: 2015-02-20T13:00:00-05:00

End: 2015-02-21T14:30:00-05:00

Tickets

Single Live : For One Participant 262.04 CAD 10

Single REC : For One Participant - Unlimited Access for 6 Months 314.54 CAD 5

Corporate Live : For Max. 10 Participants 940.92 CAD 5