North Texas Chapter: Current FDA and EMA Inspection Findings: Lessons Learned

North Texas Chapter: Current FDA and EMA Inspection Findings: Lessons Learned

• Janet E. Holwell, CCRC, CCRA, TIACR, FACRP, Consulting Instructor, Barnett International/Independent Clinical Research Consultant

This FDA and EMA Inspection Findings presentation is designed to review the most common findings from inspections and audits. It will also discuss how to use RCA and CAPA to find possible causes and actions needed to prevent reoccurrence. Case studies will be reviewed to compare what responses occurred versus how the use of RCA and CAPA could have assisted in more complete, effective responses and actions. This presentation will also include tips that may assist in the prevention of findings.

1. Understand how to use RCA tools to support quality system execution
2. Identify a possible cause, evaluate it against facts and differentiate facts from assumptions
3. Implement Gilbert’s Behavioral Engineering Model for a diagnostic root cause analysis process
4. Asses proposed Corrective and Preventative Action Plans (CAPA) for adequacy once the root cause is identified  

• CRCs
• CRAs
• Investigators
• Auditors
• Project Managers
• Regulatory Affairs/Compliance
• Data Managers (Site, Sponsor, CRO)
• Medical Monitor, Medical Officer, Project Physician
• Quality Assurance
• Clinical Research Administrators

• 8:30 – 9:00 am CDT Log on and ensure connectivity
• 9 - 11:00 am CDT Presentation, Questions & Answers

• Chapter Members: $0
  
• ACRP Members: $0
• Non-Members: $0

• Chapter Members: $0.00
  
• ACRP Members: $15.00
• Non-Members: $30.00

Refund Policy: Not applicable