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FDA Inspections - Top FDA 483 Observations and Prevention Strategies

Supplier Management Training
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)

This expanded training provides an in-depth analysis of FDA inspection processes, common observations, and prevention strategies. Participants will gain a deeper understanding of how to navigate FDA inspections successfully and proactively prevent regulatory findings such as Form 483 observations and warning letters. By leveraging real-world case studies, interactive workshops, and mock scenarios, attendees will learn to identify root causes, develop CAPA plans, and establish best practices for long-term compliance. This training ensures that professionals not only understand why FDA issues citations but also acquire the tools to prevent them from occurring.

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.

KEY LEARNING 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.


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





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