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Scheduled On : Wednesday, November 6, 2013 at 1:00 PM EDT Duration : 60 Minutes This webinar is recorded. Description : This webinar is intended to help you get familiar with the Unique Device Identification (UDI) final rules, finally issued on September 24, 2013. This webinar is further intended to help you effectively implement a unique device identification (UDI) system (UDI system). In particular, new changes in the final rules will be discussed, helping to save you an enormous amount of time, efforts and resources to achieve compliance and to remain compliant with the final UDI system requirements. In 2007, Congress passed legislation directing the FDA to develop regulations establishing a unique device identification system for medical devices. The UDI final rules are intended to establish a system to adequately identify devices during use and distribution. According to the finalized UDI rules, most medical devices distributed in the US are required to carry a Unique Device Identifier unless subject to an exception or alternative placement. The UDI system requires each device and each package to carry a UDI, the UDI of which should be provided in a plain text and in a form usable by automatic identification and data capture (AIDC) technology. If the device is intended to be used more than once and intended to be reprocessed before each use, the UDI must be directly marked on the device itself. The speaker will present how to implement the UDI system requirements in a CAC-SI manner. Areas Covered in the Session : > Applicable Statute(S), Regulations and Enforcement Authority > Definitions > UDI Development History > UDI Final Rules: Technical Requirements and Changes Made > When to Use a UDI and When to Discontinue Its Use > UDI System Requirements including Technical Standards > Requirements for a Unique Device Identifier > FDA Accreditation Process for an Issuing Agency including Suspension and Revocation > UDI Rules: Applicability > UDI Rules: Exceptions and Alternatives > Compliance Dates for the Applicable Requirements Over Seven (7) Years > Device Identifier Formats including Dates > Global UDI Database (GUDID): Technical Requirements (Data Format and Data Attributes) > Impact of the Final Rules to Many Business Areas/Processes > Changes in Device Design, Documentation and Manufacturing Processes > Practical, Actionable, and Sustainable Strategy: Good Practices to Implement UDI Systems Fast Conclusion Who Will Benefit: > R&D Scientists, Managers, Directors, and VPs > Regulatory Affairs and Compliance Professionals > Clinical Affairs Professionals > Quality Professionals > Consultants > Legal and Compliance Officers > Marketing Professionals > Senior Management > Anyone Interested in the Subject Speaker Profile: 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 e-Copy 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 for this webinar visit our website www.compliancetrainings.com or please click here You can reach us at support@compliancetrainings.com or call us at 1-416-915-4458
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Unique Device Identification, UDI, automatic identification data capture technology, AIDC, CAC-SI, FDA Accreditation Process, Global UDI Database, webinar,
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