FDA Inspection Lessons Learned: Lack of Trial Oversight

This training program will critically assess the number of major and critical 2012 inspection findings related to trial oversight. Attendees will learn to identify regulatory requirements for appropriate delegation of duties and investigator oversight.

Why Should You Attend:

Failure to personally conduct or supervise the clinical investigation is a frequent finding in regulatory inspections, and one that highlights the risk to participant safety in clinical trials. Principal investigators (PI) are required to provide adequate oversight of all clinical research activities at their sites, whether the activity is conducted by the PI or by a delegated member of the study team. Unfortunately, this isn’t always the case.

Who Will Benefit:

Principal Investigator

CRC

Monitor (CRA)

Regulatory Affairs/Compliance

Trainer/Educator

Investigator

Instructor Profile:

Janet Ellen Holwell is an independent consultant specializing in maximizing excellence in CGP quality, compliance and training for both sites and industry. She works contractually with sponsors, CROs, academic medical centers, site investigators and their personnel to provide training and mentoring in the clinical research process, specializing in ICH-GCP compliance and quality oversight.

Note:

Use coupon code NB5SQH8N and get 10% off on registration.

For Registration:

http://www.complianceonline.com/fda-inspection-lessons-learned-lack-of-trial-oversight-webinar-training-704263-prdw?channel=sciencedz