Webinars
Knowledge is Power: The Most Common Causes of 483s
03.01.18
This presentation will discuss common 483s, and how to prevent them, including:
• Lack of or inadequate CAPA procedures – 400
• Lack of or inadequate complaint procedures – 269
• Lack of or inadequate procedures involving purchasing controls – 138
• Lack of or inadequate process validation – 137
• Lack of written MDR (Medical Device Reporting) procedures – 127
• Nonconforming product; procedures not adequately established – 127
• CAPA activities or results not adequately documented – 115
Presenter:
Patrick Biggins, VP, Quality Assurance & Manufacturing,
Musculoskeletal Clinical Regulatory Advisers, LLC
