Current FDA and EMA Inspection Findings: Lessons Learned

Course Description

Failure to follow the investigational plan, inadequate Principal Investigator (PI) oversight, and informed consent irregularities remain high on the list of leading findings in U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) inspections. In this web seminar, we will examine real-world examples of some of the top 10 inspection findings from the Annual BIMO Inspection Metrics, and discuss appropriate corrective and preventive actions (CAPAs), equipping learners with solutions to avoid common pitfalls and ultimately avoid inspection findings in the future. Correct conduct according to GCP will be discussed and lessons learned applied to help prevent these findings from occurring again. Learners are encouraged to share their experiences as participants discuss methods and tools to aid in compliance through appropriate techniques for ICH-GCP compliance. Tools will be provided to assist clinical research personnel in their efforts to be ICH-GCP compliant.

Learning Objectives

• Critically assess the number of major and critical Annual BIMO inspection findings
• Provide examples of the Annual BIMO top inspection findings
• Discuss how to prevent major and critical inspection findings
• Apply the right corrective actions to resolve the major and critical inspection findings

Who Should Attend

• Principal Investigators
• Compliance Personnel
• Clinical Research Coordinators
• Clinical Research Associates/Monitors
• Regulatory Affairs Professionals
• Trainers and Educators
• Investigators
• Auditors and Inspectors

Instructor

Janet Ellen Holwell, C.C.R.C., C.C.R.A., T.I.A.C.R., F.A.C.R.P.  

Click here for complete trainer biographies

Registration Fees

$735

Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.

Note: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: customer.service@barnettinternational.com 

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-23-011-L99-P. Released: 5/23. 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.