Compliance Trainings, Canada
2015-01-16
As a domestic or foreign medical device manufacturer including an importer and user facility, you are subject to regulatory requirements for complaint handling and medical device reporting (MDR) in the US. FDA frequently cites in 483s upon establishment inspections and subsequently warning letters issued to the firms as follows. "…Your failure to establish and maintain adequate complaint handling or medical device reporting procedures…” 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. Even if it is believed that the similar or relevant procedures have been implemented in your firms, it is time to ensure all aspects of the requirements are under check to be adequate and compliant. To achieve compliance and to remain compliant with the FDA-compliant complaint handling and medical device reporting, it is imperative that the firms accurately understand, interpret, and implement the requirements for handling all complaints (electronic, written, or ORAL) and medical device reporting to be better sustainable as evident from a recent case. In this 60-min presentation, the speaker will guide you through the details of the required elements to successfully implement the medical device complaint handling and medical device reporting systems so that you can ensure your firms adequately establish and maintain the applicable systems in a PASS-IT manner. 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 Price Tags: Live Single Live : For One Participant $ 249 Corporate Live : For Max. 10 Participants $ 899 Recording Single REC : For One Participant - Unlimited Access for 6 Months $ 299 For more information and enquiries contact us at Compliance Trainings 5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada
Customer Support : #416-915-4458
Email : support@compliancetrainings.com
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