Good Documentation Practices for Clinical Trials

This webinar is intended to help you adequately implement Good Clinical Practices (GCP): in particular, 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.

The documentation requirements including 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 :

  • Statutes, Regulations and Definitions
  • Regulatory Requirements for INDs and IDEs.
  • Clinical Trials
  • Clinical Investigators (CI)
  • Institutional Review Boards (IRBs)
  • Sponsors and Monitors
  • 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 Should Attend:

  • Clinical Affairs Departments
  • Regulatory Affairs Departments
  • Quality Assurance Departments
  • Research & Development Departments
  • Consultants
  • Contractors/Subcontractors
  • Senior Management
  • Anyone Interested in the Topic

FDB2218

Dr. David Lim

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.

Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider published by FDA News.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance