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ICH-FDA Good Clinical Practice – Managing Clinical Trials

Duration : 60 Minutes

Marie Dorat,

Marie Dorat, CQA,CAA is a QA/RA compliance, GxP Training and International product registration Consultant with 17 years  experience, in the Pharmaceutical/Medical Device & IVD Industry She also is the CEO of IPRF, LLC which specializes in helping established and start-up companies, develop compliant Quality Systems; Read more

Good Clinical Practice (GCP) is an international standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials. The goal of GCP is to ensure the protection of the rights, integrity, and confidentiality of clinical trial participants and to ensure the credibility and accuracy of data and reported results.

This course provides an overview of the critical elements of Good Clinical Practice (GCP). Participants will learn practical application of GCP regulations and guidelines for critical components of the clinical research process. Specific attention will be given to Sponsor Responsibilities and Quality Management of the clinical trial.

Course Objectives:

This webinar has been specifically designed to help attendees manage a GCP compliant clinical trial. It will provide a background and understanding of the role played by the Sponsor, IRB, Investigators, and the Regulatory Authorities. Attendees will be taken through the key stages of the clinical trial processes.

Course Outline:

• The Principles of ICH GCP
• Informed Consent

          o HIPPA Compliance

• Ethics & IRB Responsibilities
• Investigator Responsibilities
• Sponsor Responsibilities

          o Quality Management
          o CRO Selection
          o Trial Design/Protocol
          o Trial Management
          o Investigator Selection
          o Data Handling/Recordkeeping
          o Essential Documents
          o Monitoring

• Auditing/ Regulatory Authority Inspections
          o FDA Warning Letters

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Clinical Quality Assurance Professionals
• Clinical Research Associates
• Project Managers
• Investigators
• Study Coordinators
• GCP-Focused Regulatory Affairs Professionals

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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