Preparation, Management, and Response to Inspections and Audits

Course Description

Faced with an impending audit or inspection, how do you prepare? If inspection results in findings, do you have the skills and tools to best respond to these issues to avoid further actions? This web seminar will provide an overview of what to expect and how to prepare for an audit or inspection. Real case scenarios in a workshop format will be used to help solve the dilemmas faced by both sites and industry when faced with discoveries from regulatory authorities or auditors. Steps for preparation, on-site auditing and follow-up actions will be explained. Interactive exercises will be incorporated utilizing FDA Warning Letters. Participants will learn how to perform root cause analysis (RCA) and prepare corrective and preventive actions (CAPAs).

Learning Objectives

• Describe the anatomy of a regulatory inspection
• Recognize how to best prepare and manage expectations
• Discuss appropriate strategies for responding to inspection findings and implementing realistic and appropriate corrective and preventive actions (CAPA)
• Employ the right corrective actions to resolve the major and critical inspection findings

Interactive Activities

• Root Cause Analysis exercise
• Forensic examination of FDA Warning Letters

Who Should Attend

• Investigators
• Clinical Research Coordinators
• Clinical Research Associates
• Compliance Professionals
• Project Managers and Site Managers
• Quality Assurance Personnel

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

$1,045

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 4 hours (0.4 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#: 0778-0000-22-008-L04-P. Released: 1/22.  

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