How to Implement Good Clinical Practices for Successful FDA and International Regulatory Authority Inspections

In this webinar you will learn How to Implement Good Clinical Practices for Successful FDA and International Regulatory Authority Inspections.

Angela Bazigos
Instructor:
Angela Bazigos
Date:
Wednesday, April 17, 2019
Time:
10:00 AM PDT | 01:00 PM EDT
Duration:
90 Minutes

More Trainings by this Expert   Product Id : 502439

Price Details
$150 Live
$290 Corporate Live
$190 Recorded
$390 Corporate Recorded
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Live + Recorded
$289 $340 Live + Recorded
Corporate (Live + Recorded)
$599 $680 Corporate
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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.

Given the disparity between the detailed nature of clinical trial processes and tasks and the general GCP requirements and standards under which they occur, it is not surprising that interpreting and implementing GCP standards continue to represent challenges for the pharmaceutical, biotechnology, and medical device industries

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. Positions include Chief Compliance Officer,Director of QA and MIS Director. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA & DIA Patent on speeding up software compliance https://www.google.com/patents/US8266578.

Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom includes training for Society of Quality Assurance.

Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford's Who's Who for LifeSciences.




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