GOOD CLINICAL PRACTICE AUDIT PROGRAMFOR CLINICAL C 2016 - GCP violation commonly found During a FDA Investigator Site Inspection/ Audit and how to avoid them - By Compliance Global Inc

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Category Education; E-Learning

Deadline: August 16, 2016 | Date: August 16, 2016

Venue/Country: New York, U.S.A

Updated: 2016-07-20 21:56:11 (GMT+9)

Call For Papers - CFP

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?

Learning Objectives:

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

For more information, please visit : https://complianceglobal.us/product/700514/CharlesHPierce/gcp-violation-found-during-a-fda-investigator-site-inspection-audit/1

Email: supportcomplianceglobal.us

Toll Free: +1-844-746-4244

Tel: +1-516-900-5515

Level:

Intermediate

Speaker Profile:

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.