Practices for Successful FDA and International Regulatory Authority Inspections

Overview:

This webinar will highlight the salient points of Good Clinical Practice and will enable the participants to understand how to implement GCP to achieve clinical trial best practices, best patient safety and/or successful FDA and international regulatory authority inspections.

Why should you Attend: At its core, Good Clinical Practice (GCP) is a set of broad regulatory requirements, standards, and recommendations that apply to thousands of highly specific tasks, processes, and roles in the conduct of clinical research. It is important to remember that much of the practical standards used in the conduct of clinical trials are "best practices" derived from regulations, guidance, and industry standards and practices and not all found in black and white in the regulations.

Areas Covered in the Session:

• Define Good Clinical Practice (GCP)
• Outline the goals of GCP
• Provide a historical perspective on GCP
• Outline FDA regulations relating to GCP in medical device research
• How to implement GCP
• How FDA Inspects for GCP
• How FDA GCP relates to international regulations

Who Will Benefit:

• Doctors
• Nurses
• Regulatory Affairs
• Quality Assurance
• Regulatory Authority Inspectors
• Clinical Safety Personnel
• Clinical Data Management Personnel
• IT personnel working on Clinical Systems

Speaker Profile
Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital.