Webinar on Best Practices for Medical Device Recalls

By: Compliance Trainings  13-10-2014
Keywords: Medical Device, Clinical Affairs, Medical Device Recalls,

In the United States, medical device firms are subject to compliance to the FDA regulations of device recalls, correction and removals. To achieve compliance and to remain compliant, it is critical to understand how to establish and maintain adequate procedures for medical device recalls, corrections and removals. This webinar is intended to help device industry establish adequate procedures for medical device recalls, corrections and removals and further to provide practical, actionable, and sustainable perspectives by increasing awareness and familiarity of the applicable requirements. This webinar will provide a great opportunity to adequately plan, develop and execute the relevant procedures in an effective, sustainable manner compliant with the recall requirements enforced by US FDA. Areas Covered in the Session : Laws And Regulations Definitions Regulatory Requirements For Medical Device Recalls Voluntary Recalls Health Hazard Evaluation Recall Classification Recall Strategy Recall Letter, Envelope, and Return Response Recall Effectiveness Check: Letter, Questionnaire, and Response Recall Status Reports Terminating a Recall Public Notification Mandatory Device Recall Corrections And Removals Recall Reporting Documentation Requirements Checklists Enforcements: Case Studies PASS-IT Recommendations: Best Practices Who Will Benefit: CEOs VPs Clinical Affairs Regulatory Affairs Quality Professionals R&D Complaint And Risk Management Personnel Consultants Contractors/Subcontractors Other Interested Parties Price List: 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 : [email protected] For more information about this event please visit https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1355

Keywords: Clinical Affairs, Complaint And Risk Management, Dr. David Lim, FDA Recall Reporting, FDA Recall Status Reports, FDA regulations of device recalls, Medical Device, medical device corrections, Medical Device Recalls, medical device removals, US FDA recall requirements,