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

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Larry Larry

Speaker: Larry Spears
Duration: 90 Minutes
Product ID: 700102

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Medical Device Export Approvals and Certificates in compliance with FDA regulations

Firms exporting products from the U.S. are often asked by foreign customers or foreign governments to supply proof of the products’ status as regulated by the FDA. An export certificate is a more...

Larry Larry

Speaker: Larry Spears
Duration: 60 Minutes
Product ID: 700088

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Corrective and Preventive Action (CAPA) and Complaint Handling in Medical Device.

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 looki more...

Larry Larry

Speaker: Larry Spears
Duration: 60 Minutes
Product ID: 700084

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Registration & Listing, FDA Inspection Strategies and Compliance Initiatives - Medical Device.

Have you ever wondered about the FDA strategies for scheduling inspections and pursuing compliance plans?  This seminar will provide clarity around those issues from a compliance expert with o more...