Auditing Sponsors and CROs: Deconstruction and Application of the FDA’s Compliance Program Guidance Manual

Course Description

As scrutiny of sponsors, Contract Research Organizations (CROs), and monitors involved in the conduct of clinical research intensifies, companies are using their quality assurance resources to review internal (and vendor) systems to ensure compliance within a changing regulatory environment. A systematic application of the Compliance Program Guidance Manual (CPGM) permits identification of regulatory risks during qualification and in-process audits. This web seminar will review the FDA’s current guideline for conducting inspections and how to apply them to assess Quality Systems. Assessment of the SOPs that are expected for sponsors and CROs, including registration of trials and informed consent document issues, will also be discussed.

Learning Objectives

• Integrate new regulatory requirements and processes into audits
• Translate inspection criteria to Quality Systems that support changes in inspection focus
• Assess the FDA’s application of the CPGM as reflected in regulatory communication
• Examine steps for preparation of an inspection

Who Should Attend

• Professionals from Academia whose institutions or investigators hold INDs or IDEs, or whose institutions support clinical research with Site Management Organizations (SMOs)
• Clinical Quality Assurance Auditors
• Clinical Quality and Compliance Professionals
• Clinical Research Associates
• Project Managers
• Medical Monitors
• Regulatory Affairs Professionals
• Clinical Research Coordinators

Instructor

Elizabeth Ronk Nelson, M.P.H.

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 2 hours (0.2 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#: 0778-0000-24-011-L99-P. Released: 3/24. 

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