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We Empower, You Comply! Medical Device Reporting - How to establish and maintain adequate procedures Product Id
Wednesday, May 14, 2014 at 13:00 Hrs
Dr. David Lim To visit our website www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1118
Webinar Description: This webinar is intended to help you avoid FDA 483s and warning letters for failure to establish and maintain adequate procedures for medical device reporting. Device manufacturers are required to establish and maintain medical device reporting procedures pursuant to the FDA regulations. In the United States, since December 13, 1984, the Food and Drug Administration (FDA) Medical Device Reporting (MDR) regulations have required firms who have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify FDA of the incident. MDR is the mechanism for the FDA to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. To achieve compliance and to remain compliant, it is critical to understand how to define, document and implement the MDR procedure to survive FDA inspections – avoiding FDA 483s and warning letters. This webinar is aimed at helping device industry understand how to establish and maintain adequate procedures for MDR and further to provide practical and actionable perspectives by increasing awareness and familiarity of the applicable requirements. In this webinar, you will learn what is required to achieve compliance and stay compliant with MDR regulations.
Areas Covered in the Session :
Applicable Statues and Regulations Definitions MDR Regulatory Requirements MDR Standard Operating Procedures (SOPs): Required Elements MDR Criteria Determining and Reporting MDR Events Reporting Requirements for the User Facilities, Manufacturers, and Importers Integrating Unique Device Identification (UDI) Enforcements: Case Studies Common Mistakes and Consequences Best Practices Speaker’s PASS-IT Solutions
Who Will Benefit:
Clinical Affairs Regulatory Affairs Quality Research & Development Complaint and Risk Management Consultants Senior Management Contractors/subcontractors Other interested parties
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.com). Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with eCopy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009. Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. To register our webinar visit our website www. compliancetrainings.com/SiteEngine/MedicalDevices.aspx
Published on May 1, 2014
Compliance Trainings would provide training on various concepts like Class I, II and III devices, 510(k), Premarket Approval (PMA), IVD’s (I...