Good Clinical Practice (GCP) for Medical Devices
Training Overview
Improve Your Ability to:-
Comply with FDA GCP requirements related to medical devices and avoid regulatory enforcement actions
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Determine components of a typical BIMO inspection and ensure you are well prepared to pass such inspections
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Determine the specific roles of sponsors, monitors and clinical investigators and ensure that you work together as an effective team
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Clarify the similarities and differences between pharmaceutical and medical device GCPs and determine exactly what requirements with which you must comply
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Develop concise clinical protocols, SOPs, source worksheets and ensure you properly document your device trials
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Interact appropriately and successfully with an IRB and avoid trial delays and setbacks
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Meet adverse event reporting requirements and write appropriate informed consent documentation to help protect human subjects involved in device trials
- Comply with international trial requirements and prepare to conduct trials abroad
The Medical Device Manufacturers Association (MDMA) is a national trade association based in Washington DC advocating on behalf of thousands of innovative and entrepreneurial medical technology companies, including hundreds of dues paying members. We represent our members' collective interests before the United States Congress, the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS) and other federal and state agencies that develop or implement policies that affect our industry.
PTi international is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmaceutical education. Participants will receive a maximum of 14 hours (1.4 CEUs) of continuing education credit for full participation in the two-day training. ACPE # 326-000-05-125-L04, Initial release: 05/2004.