ICH-FDA Good Clinical Practice – Managing Clinical Trials

Duration: 60 Minutes
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.
Good Clinical Practice Guidelines
Instructor: Marie Dorat
Product ID: 500234

Why Should you Attend:
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.

Objectives of the Presentation:
  • The Principles of ICH GCP
  • Informed Consent
    • HIPPA Compliance
  • Ethics & IRB Responsibilities
  • Investigator Responsibilities
  • Sponsor Responsibilites
    • Quality Management
    • CRO Selection
    • Trial Design/Protocol
    • Trial Management
    • Investigator Selection
    • Data Handling/Recordkeeping
    • Essential Documents
    • Monitoring
  • Auditing/ Regulatory Authority Inspections
    • FDA Warning Letters
Who can Benefit:
  • Clinical Quality Assurance Professionals
  • Clinical Research Associates
  • Project Managers
  • Investigators
  • Study Coordinators
  • GCP-Focused Regulatory Affairs Professionals
$300
Recorded Session for one participant
Get life time access with download option!
Book this course
Pay Now
  $450.00 Training CD
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
  $550.00 Training USB Flash Drive
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
For multiple location please contact our customer care team +1-510-857-5896.
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Marie Dorat, CQA,CAA is a QA/RA compliance, GxP Training and International product registration Consultant in the Pharmaceutical/Medical Device & IVD Industry She also is the CEO of IPRF, LLC which specializes in helping established and start-up companies process the necessary documents for international product distribution.

Ms. Dorat has 13 years’ experience in quality assurance and regulatory affairs in the pharmaceutical/Medical Device & IVD industry, including auditing clinical trials, manufacturers, and distributors in the US and internationally. She has held a number of senior QA/RA positions. She has worked for several companies including Pfizer, and Alere She has lectured at conferences and provides on-site training courses on QA and GxP issues.

She has also worked directly with various companies in the Pharmaceutical & Medical Device industry, assisting with international new product registrations as well as rebranding products after an acquisition or merger. She has developed a process to reduce time to market for most companies by several months. She provides training courses both for public groups and in-house on topics including: International Product Registration project management, Auditing 101, Writing and managing Quality Systems, GCP , Regulatory requirements for Clinical Trials, FDA audit and EU inspection- How to Prepare,.
View More