FDA Inspections - Top FDA 483 Observations and Prevention Strategies

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

DAY 1 (9 AM to 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 to 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)

Meredith Crabtree has over 30 years’ experience in regulated industries, ranging from Blood, Plasma, Tissue, Laboratory, Pharma, Medical Device, Cosmetics, Supplements, and Animal Health. This includes manufacturing, packaging, labelling and distribution operations. Meredith is the owner of MLKC Consulting is s a Quality Consultant specializing in product label reviews, 3rd party inspections, Consent Decree and Recall support. She also performs regulatory assessments and Quality trainings.