Webinar On Complaint Handling & Medical Device Reporting (MDR)
January 16, 2015 - Mississauga ON CACompliance Trainings
uttam@compliancetrainings.com
Phone:4169154458
This presentation is intended to help global medical device firms and stakeholders adequately implement US FDA-compliant medical device complaint handling and medical device reporting (MDR) systems. Areas Covered in the Session : Applicable Laws and Regulations Definitions Requirements for Complaint Handling Requirements for Medical Device Reporting Applicable Processes and Procedures Key Elements in the Procedures: Complaint Handling and MDR What to Do When a Complaint Is Received What/How/When to Investigate a Complaint Complaints Investigation and Documentation Medical Device Reporting How to Determine Reportable Events Establishing Reportability Criteria Additional Documentation Requirements for MDR Mistakes and How to Avoid Mistakes and 483s Relationships between Complaint Handling, MDR, and CAPA Enforcement Case Studies Improving Our Awareness and Continuous Improvement Speaker’s PASS-IT suggestions and recommendations Who Will Benefit: Complaint Managers Regulatory Affairs Quality Clinical Affairs R&D engineers and scientists, managers, directors, VPs Compliance and Legal Affairs CRO Auditors and Consultants Senior Management Anyone Interested in Medical Device Complaint Handling Systems