Annual Current Good Clinical Practices (cGCP) Training
Instructor:
Shana Dressel
Product ID: 705408
- Duration: 60 Min
Why Should You Attend:
In 1938, a newly enacted U.S. Food, Drug, and Cosmetic Act subjected new drugs to pre-market safety evaluation for the first time. The ethical advances in human protection include several milestones - Nuremberg Code, Declaration of Helsinki, Belmont Report, and 1996, International Council for Harmonization Good Clinical Practice (ICH-GCP) guidance, all influencing the regulations and guidelines that are applied to clinical research in the 21st century.
Individuals (healthcare professionals and support staff) involved in planning, conducting, or reporting human subject research must have documented training and working knowledge of the federal regulations, international regulations, and guidelines applied to clinical research.
This webinar is designed to provide an overall understanding and basic knowledge of the history and regulations/guidelines as applied to clinical research. This training will fulfill the requirement of healthcare professional and support staff involved in human subject research to have documented training on regulations and guidelines applied to clinical research.
Areas Covered in the Webinar:
- History and outline of milestones in regulation and guidelines of clinical research
- Review federal regulations for clinical research and drug development
- Describe the role of International Council for Harmonisation and how it applies to clinical research
- Discuss responsibilities for individuals working in clinical research
- Discuss best practices in clinical research
- Listing of significant definitions as applied to clinical research
Who Will Benefit:
- Principal Investigators
- Clinical Research Coordinators
- Nurses
- Study Managers
- Screening Coordinators
- Recruitment Staff
- Regulatory Administration
- Quality Staff
- Clinical Research Associates
- Clinical Data Manager
- Clinical Data Specialist
Shana Dressel
Senior Consultant, The Compliance Edge LLC
Shana Dressel is a highly proficient and accomplished leader in Quality Assurance with over 17 years of experience within FDA regulated industries, clinical development through large scale manufacturing (GXP), including large and small molecule drugs, medical devices, and dietary supplements.
Shana possesses extensive experience in company leadership, quality management, client interaction, regulatory inspection management, supplier management, and GXP auditing. She works with global, industry leaders of drug development and clinical research, providing guidance in regulatory, quality and compliance situations with extensive experience in all phases of drug and device development.
Refund Policy
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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
