Strategies for Good Clinical Practice Audits

Learn basic knowledge of Good Clinical Practice audit programs and strategies.  This online course is designed to help you with types of audits and inspections, audit reporting, general procedures in preparing for an FDA audit, and role and findings of FDA audits.

• Audit programs and strategies
• Role of the audit
• Audit preparation, managing and follow-up
• FDA audits, outcomes and follow-up

• Clinical research associates
• Quality assurance auditors
• Data management professionals
• Medical writers
• Regulatory affairs professionals

At the conclusion of this activity, participants should be able to:

• Describe the quality assurance audit process
• Strategically plan, prepare for and organize an GCP inspection
• Recognize the various type of audit programs and strategies
• Manage the GCP audit process and how to ensure a successful outcome