Best Practices Compliant with the FDA Regulations for Handling Medical Device Complaints Description: Medical device manufacturers, device user facilities, and applicable stakeholders are required to establish and maintain adequate procedures for handling complaints. This webinar is intended to help you get familiar with the regulatory requirements and how to establish and maintain an effective complaint handling system applicable to all device types. Implementing an effective complaint handling system is of paramount importance to the device manufacturers and the stakeholders and will help to save significant amount of time and efforts in business while ensuring the safety and effectiveness of your medical device products. This webinar will discuss the applicable regulatory requirements and how to establish and maintain the adequate procedures for handling complaints. This 60-min webinar will help you get familiar with all the elements that are necessary to achieve compliance and to remain compliant with the FDA complaint handling regulations. Objectives of the Presentation: Legal authorities (statutes and regulations) and definitions Regulatory requirements and compliance Implementing applicable processes and procedures What to do when a complaint is received What/how/when to investigate a complaint Contents of records of investigation How to adjudicate the complaint Implementing interactive systems between complaint handling, medical device reporting, and CAPA Numerous case studies Lessons learned Who can Benefit: CEOs VPs Compliance Officers Attorneys Complainant Managers Managers (RA, QA/QC, CA) Consultants Contractors and Subcontractors Training Options Duration: 60 Minutes
Recorded Session Access recorded sessions only for one participant unlimited viewing for 6 months. Price: $288.00