Have you ever wondered about how FDA approaches CAPA (corrective and preventive actions) and complaint issues during inspections? What about how they manage those activities and what they are looking for? This webinar will provide clarity around those issues from a compliance expert with over 30 years’ experience in inspection and compliance management.
Why Should You Attend
Many companies do not know what they don’t know when it comes to dealing with the FDA. By not understanding how FDA looks at CAPA corrective action and complaint problems, these companies oftentimes fail to manage inspections to reduce the risk of adverse findings. After the inspection, they fail to address key issues in response to fda 483s and Warning Letters. Here is your chance to better understand how FDA thinks and operates in managing these key inspection systems from a former medical device compliance insider.
Areas Covered in this Webinar
CAPAs and complaints are key focus areas having GMP guidelines and this webinar will review the ins and outs of how to manage these systems and effectively address questions FDA will likely raise during inspections.
• Why CAPAs and complaints are so important to FDA
• How to be prepared for an FDA inspection of these areas
• How FDA uses data from inspections
• How to avoid or reduce risk in managing product experience data of this sort
Who Will Benefit
• VP’s in Quality Assurance
• Directors in Quality Assurance
• Quality Managers
• Quality Professionals
• Small Business Owners
Larry Spears has deep regulatory expertise from over 35 years´ experience in government and consulting. This includes investigations, compliance and regulatory roles with FDA including senior compliance leadership positions in the CDRH Office of Compliance, as a consultant with a large life sciences consulting firm and as an independent consultant. Mr. Spears provides global regulatory strategy consultation to Life Science companies primarily in medical devices/diagnostics and pharmaceuticals with a focus on quality systems gap assessments, FDA mock inspections, quality system development and planning, and remediation for FDA inspection findings including, CAPA and complaints, design controls, supplier controls, production management, and training