April 15 - 16, 2025 | US Eastern Time: 9 AM to 2 PM | Central Europe Time: 3 PM to 8 PM
AGENDA
DAY 1 (9 AM - 2 PM)
FDA Inspection Process & Common Observations
- Understanding FDA Inspections & Regulatory Expectations
- Decoding the FDA 483 Process & Establishment Inspection Reports
- Observation Type 1: Inadequate Documentation & Record-Keeping (Workshop: Reviewing FDA citations and improving documentation)
- Observation Type 2: Employee Training Deficiencies (Exercise: Developing a compliant training program)
- Observation Type 3: Failure to Follow SOPs (Case study analysis of real FDA citations)
DAY 2 (9 AM - 2 PM)
Prevention Strategies & CAPA Development
- Observation Type 4: CAPA Deficiencies & Root Cause Investigations (Hands-on CAPA writing exercise)
- Observation Type 5: Facility & Equipment Failures (Mock facility walkthrough identifying potential 483 risks)
- Observation Type 6: Data Integrity & Reporting Issues (Real-world case study on falsified records & FDA enforcement)
- Developing a Culture of Compliance & Continuous Improvement (Interactive strategy session)
SEMINAR OBJECTIVES:
Master the FDA Inspection Process:
- Gain insights into pre-inspection preparation, inspection conduct, and post-inspection actions.
Understand the Top FDA Observations:
- Deep dive into common citations, including documentation failures, training deficiencies, and CAPA weaknesses.
Learn How to Conduct Effective Root Cause Analysis:
- Develop investigation strategies using case studies and mock FDA inspection exercises.
Ensure CAPA Effectiveness:
- Learn best practices for writing, implementing, and following up on CAPA plans.
Improve SOPs and Training Programs:
- Identify weaknesses in training approaches and standard procedures to enhance regulatory compliance.
Master Data Integrity and Documentation Compliance:
- Learn how to mitigate risks related to data integrity, missing records, and inadequate testing.
Implement Proactive Compliance Strategies:
- Shift from reactive fixes to proactive solutions for continuous improvement and inspection readiness.
WHY YOU SHOULD ATTEND:
This training is essential for professionals who:
- Need to understand the FDA inspection process and avoid common compliance pitfalls.
- Want to build strong SOPs and training programs to prevent observations.
- Are responsible for CAPA development and deviation investigations.
- Need to ensure data integrity, proper record-keeping, and robust documentation.
- Seek to establish proactive compliance strategies to avoid regulatory enforcement.
WHO SHOULD ATTEND:
- Quality Assurance Departments
- Quality Control Departments
- Regulatory Affairs Departments
- Manufacturing Departments
- Engineering Departments
- Research and Development Departments
- Compliance Departments
- Production Departments
- Documentation Departments
- Operations Departments
- Training and Development Departments