Compliance Trainings, Online
2015-06-22
Description : This webinar is intended to help you adequately implement Good Clinical Practices (GCP) including 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. GCP requirements including documentation requirements (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 : Laws and Regulations Definitions Clinical Trials and Requirements Regulatory Requirements for INDs and IDEs. Duties and Responsibilities for Clinical Investigators (CI), Institutional Review Boards (IRBs), Sponsors and Monitors, and Contract Research Organizations (CROs) ICH-GCP Guidelines ISO 14155 List of SOPs and Adequate Documentation Key Elements in the SOPs Common GCP Deficiencies in EU and US Enforcement Actions Lessons Learned Who Will Benefit: Clinical Affairs Regulatory Affairs Quality Assurance Research & Development Consultants Contractors/Subcontractors Senior Management Anyone Interested in the Topic Price tags: Live Single Live : For One Participant $ 249 Corporate Live : For Max. 10 Participants $ 899 Recording Single REC : For One Participant - Unlimited Access for 6 Months $ 299 For more information and enquiries contact us at Compliance Trainings 5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada
Customer Support : #416-915-4458
Email : support@compliancetrainings.com
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