FDA/EU INSPECTIONS

Service Description

Learning Objectives By the end of this course, participants will be able to: - Comprehend FDA and EU inspection processes, key expectations, and recent trends in findings. - Create basic readiness plans, including gap assessments and mock audit practices. - Apply documentation best practices and handle inspections with effective communication. - Develop initial post-inspection responses to ensure ongoing compliance. Key Topics Covered 1. Overview of FDA/EU Inspections (20 minutes): Key inspection types, regulatory roles (FDA, EMA, MHRA, Notified Bodies), and common compliance challenges. 2. Pre-Inspection Preparation (40 minutes): Risk assessments, internal audits, staff training, and readiness checklists with practical examples. 3. Documentation and Data Integrity (20 minutes): Maintaining compliant records, ALCOA+ principles, and electronic system management. 4. Managing and Responding to Inspections (40 minutes): Hosting strategies, interview techniques, query handling, and initial CAPA development through role-playing. Delivery Format Conducted virtually or in-person with a mix of instructor-led presentations, quick polls, and group interactions. No prerequisites; includes a concise digital guide with checklists and regulatory links for immediate application. Target Audience This course is tailored for life sciences professionals such as quality assurance (QA) specialists, regulatory affairs experts, compliance officers, clinical and manufacturing staff, auditors, and managers in pharmaceuticals, biologics, or medical devices. Ideal for those facing upcoming FDA, EMA, MHRA, or Notified Body inspections, including beginners or those needing a concise refresher. Benefits Participants will acquire essential tools to boost inspection preparedness, lower compliance risks, and promote quality culture. This training supports career growth, certification credits, and helps avoid costly regulatory issues in fast-paced life sciences environments. Date: MARCH 24th, 2026