30-Hour Clinical Research Auditing Certification Program (Jun 08 - Aug 10, 2023)

30-Hour Clinical Research Auditing Certification Program is organized by Barnett International and will be held from Jun 08 - Aug 10, 2023.

Description:
The online 10-Week Clinical Research Auditing Certification Program provides a comprehensive introduction to clinical research and the job function of the Clinical Quality Assurance Auditor for drug, biologic, and device trials. This program is geared toward individuals seeking a new career or transitioning into Good Clinical Practice (GCP) auditing. Case studies and industry best practices are presented to emphasize how the learning objectives apply directly to the responsibilities of the GCP auditor.

The resources required to take this on-line course are already at your fingertips - an Internet connection and a phone. After registering, you will receive an email confirmation that provides you with the Web Seminar link and audio connection information.

Prior to the start of the course, participants will receive Module 1 materials. Course materials for subsequent modules will be sent weekly prior to class. Come to class prepared to interact – you will be able to ask questions, provide feedback and participate in discussions and group work. Upon course completion, participants will be provided training certificates. In order to receive accreditation CEUs, participants are required to pass both a mid-term and final exam. Upon completion of the exams, CEU certificates will be provided.

Learning Objectives:
• Describe and discuss the investigational product development process, including FDA regulations, ICH guidelines, and Good Clinical Practices (GCPs)
• Explain the roles and responsibilities of a Clinical Quality Assurance Auditor
• Describe the types of audits, including the responsibilities of the auditor in preparation, activities, and follow-up
• Examine and apply the FDA’s methods for inspections of Clinical Investigators, IRBs, sponsors/CROs
• Discuss regulatory compliance and quality assurance issues and documentation

Course Outline:
• Module 1: Investigational Product Development, the FDA, and Good Clinical Practice Guidelines
• Module 2: Auditing as a Profession and Compliance Tool
• Module 3: The Types of Clinical Research Audits and Preparation
• Module 4: Quality Systems for Auditing
• Module 5: Risk-Based Auditing and Developing Risk-Based Auditing Plans
• Module 6: The Auditing Process: Clinical Investigator
• Module 7: The Auditing Process: Institutional Review Board/Ethics Committee
• Module 8: The Auditing Process: Sponsor/CRO
• Module 9: Gathering and Disseminating Information: Verbal and Written Communication
• Module 10: Regulatory Classification and Communication: Recent Inspection Findings