ComplianceOnline

Expert Profile


John Chapman
Manager, Regulatory Affairs, Cooper Surgical, Inc.

John Chapman, BS, MBA, RAC has over 30 years medical device regulatory experience and over 10 years experience with the European Union's medical device directive, 93/42/EEC. John has led two device companies to ISO quality system certification and CE marking. He has been performed regulatory due diligence on over a dozen acquisitions in the past 12 years, exposing him to numerous quality systems, including consent decrees as well as many notified bodies.

Trainings by Expert

Medical Device CE Mark & Quality System Certification: Recent & Proposed Changes
Category: Medical Devices , Marketing and Promotion , Regulations & Guidances , Life Sciences , Regulatory Affairs

Medical Device Complaints, MDR's and Recalls
Category: Medical Devices , All FDA Regulated Industry , FDA Audit and Inspection , Marketing and Promotion , Crisis Management , Documentation and Policy Management , Lifescience process & Procedures , Life Sciences , Regulatory Affairs

Reprocessing Reusable Medical Devices - Cleaning & Labeling Requirements - validations
Category: Medical Devices , Marketing and Promotion , Testing and Validation , Life Sciences

Verification vs. Validation in FDA Regulated Industries
Category: Medical Devices , Risk Management , All FDA Regulated Industry , FDA Validation , Testing and Validation , Documentation and IT , Risk Management & Controls , All FDA Regulated Functions , Life Sciences

Complaint Handling, MDR's & Recalls
Category: Medical Devices , All FDA Regulated Industry , Marketing and Promotion , Crisis Management , Life Sciences

Reprocessing Reusable Medical Devices - Cleaning and Labeling Requirements
Category: Medical Devices , Marketing and Promotion , Testing and Validation , Sterilization , Life Sciences

Understanding ISO 13485 vs. ISO 9001 for Successful QMS in Medical Device Industries
Category: Medical Devices , QMS, ISO 13485, CAPA , Life sciences QA/QC , Life Sciences , QA/QC

Failure Modes and Effects Analysis - An effective Risk Management Tool
Category: Medical Devices , Risk Management , Quality Management , Testing and Validation , QMS, ISO 13485, CAPA , Supply Chain and Manufacturing , Audit & Inspection-Role , Medical Device Inspection , Documentation and Policy Management , Lifescience process & Procedures , Life sciences QA/QC , Research & Development , Device R & D , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management , QA/QC

From Premarket Notification to Recalls - Comprehensive Medical Device Regulations Training Package
Category: Medical Devices

FMEA and Risk Management for Medical Devices
Category: Medical Devices