GCP violation commonly found During a FDA Investigator Site Inspection/ Audit and how to avoid them
Key Take Away:
This Webinar will review FDA inspection program details and how to ensure your clinical compliance site is prepared for an inspection on focus areas likekey component identification of a good clinical practice audit program and helpful hints to help you avoid the common GCP mistakes and to enhance the overall audit experience.
To know the protocol and other GCP violations, the FDA auditors find is great for prevention at your clinical drug trials site. The adage of Forewarned is Forearmed clearly applies. Attending this Webinar is a good step toward learning the FDA processes and why a knowledgeable PI is so important.
Why Should You Attend:
GCP Investigator medical trials site audits are a routine and a necessary part of the clinical trial process. If you are participating in a clinical trial or multiple trials as a Principal Investigator, a study coordinator, a monitor, or even as the IRB chances are that you may be audited. This Webinar will cover the most frequently found GCP violations / mistakes that are often found during the audit process. In addition, how to prevent audit findings you wish were not there.
Areas Covered In This Webinar:
• The historical background of why studies are audited
• Studies targeted for auditing?
• How following GCP will end up making you look good to inspectors?
• How do you prepare for an audit?
• What Does the Inspector/Auditor look for?
• What are the common GCP mistakes made?
• How to prevent and detect misconduct and fraud?
• What happens after an inspection is done?
• Identify at least 4 mistakes made during an audit
• List at least 3 strategies to improve audit outcome
• Utilize audit preparation tools identified in the Webinar
• Describe how to prevent each of the top Audit findings that would lead to a 483
Who Will Benefit:
• Pharmaceutical, Biological and Device Companies with an active pipeline of products and planning on global studies
• Principal Investigators and Sub Investigators
• Clinical Research Scientists (PKs, Biostatisticians)
• Research Managers
• Safety Nurses
• Clinical Research Associates (CRAs) and Coordinators (CRCs)
• Recruiting Staff
• QA / QC Auditors and Staff
• Study Monitors
• Clinical Research Data Managers
Charles H. Pierce
Charles H. Pierce, MD, PhD, FCP, CPI Has 25+ years experience in the Clinical Research field. He now brings the message (via webinars, lectures and seminars) of Risk Management through knowledge of GCP Regulations and Investigator Responsibility to the entire investigative team to help them understand the regulations as well as the ethics of research involving human subjects. He has been involved in developing Phase I & IIa Clinical Pharmacology Units, Investigator and staff GCP training, and medical monitoring in both drug and device studies.