Webinar on Best Practices for Medical Device Recalls
November 6, 2014 - Mississauga ON CACompliance Trainings
suzzane.d@compliancetrainings.com
Phone:4169154458
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