Test

Product Id: 1001

5 Days Left To REGISTER

Training Options

  • Thursday & Friday, September 25, 2014 |   09:00 AM to 06:00 PM |    Duration: 2 Days  
  • Refund Policy

Overview:



Overview: An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.

The results of this evaluation should lead to a conclusion regarding whether the complaint was valid, what the root cause of the complaint was, and what action is necessary to prevent further occurrences. Complaints cannot be ignored. They are an excellent indicator of problems with the use, design, and/or manufacture of a product. A single complaint that is thoroughly investigated may lead a company to take remedial or corrective action. It may also take an ongoing analysis of numerous complaints before a trend is spotted that causes a company to initiate changes in their product, labeling, packaging or distribution. The regulatory expectations for both pharmaceuticals and medical devices will be emphasized as well as overview of best practices for timely and effective investigations. Trending is the only way a company can stay on top of emerging quality issues and address those that are most pressing.

Medical Device Reporting (MDR) is the mechanism for FDA to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. User Facilities (e.g., hospitals, nursing homes) are required to report suspected medical device related deaths to both the FDA and the manufacturers. User facilities report medical device related serious injuries only to the manufacturer. If the medical device manufacturer is unknown, the serious injury is reported by the facility to FDA. Health professionals within a user-facility should familiarize themselves with their institution procedures for reporting adverse events to the FDA.

The MDR process impacts device user facilities, manufacturers, importers, and distributors. If you are a device user facility, you must report deaths and serious injuries that a device has or may have caused or contributed to, establish and maintain adverse event files, and submit summary annual reports. If you are a manufacturer or importer, you must report deaths and serious injuries that your device has or may have caused or contributed to, you must report certain device malfunctions, and you must establish and maintain adverse event files. If you are a manufacturer, you must also submit specified follow-up.
Why should you attend:
  • Understand that although FDA does not specify a standard complaint handling system, the requirements do specify certain actions that shall be included in any system
  • Grasp and comprehend the definitions and elements of the regulatory requirements for Complaint Handling, Medical Device Reporting and handling of Recalls
  • All personnel who deal with customers, or who may receive a complaint call, must be trained in the proper routing/handling of complaints
  • Provide information about FDA's Medical Device Reporting (MDR) regulation and the Voluntary Reporting program called MedWatch
  • Introduce you Medical Device Reporting and to help you better understand the process and benefits of Voluntary Reporting and responsibilities
  • Latest Amendments to the MDR Regulation to Implement FDAMA Changes
  • To Recall or Not to Recall: Issues to consider regarding whether a Field Action is required
  • Determine when a recall is required and how to manage a recall, who must report, when to report, what to report, where to report, recordkeeping requirements, FDA regulatory authority, references and guidance
  • Seminar attendees are encouraged to bring examples of their work from the functional area on the various topics as applicable for group discussion
  • Review and discuss pain points, challenges and solutions
Who will benefit:
  • Regulatory Affairs Management
  • Regulatory Affairs Specialist
  • Auditors
  • Compliance Officer
  • Compliance Specialist
  • Clinical Affairs
  • Quality Assurance Management
  • Marketing & Sales
  • Distributors/Authorized Representatives
  • Legal Counsel
  • Engineering/Technical Services
  • Operations/Manufacturing
  • Consultants
David R. Dills, Regulatory Affairs & Compliance Consultant currently provides regulatory, compliance and quality consultative services for medical device and pharmaceutical/combination manufacturers, and also has an accomplished record with more than 24 years of experience with Class I/II/III medical devices, In Vitro diagnostics, and pharmaceuticals in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO.

Since 2000, has provided consultative services on behalf of manufacturers and subcontracted by third-party consultancies and provides services involving all phases of the product development, submission, and commercialization process; Agency inspection readiness preparation and remediation; preparing Agency responses due to enforcement actions; conducting audits and assessments and preparing CAP/remediation plan; compliance engineering support, regulatory planning; post-marketing surveillance and vigilance reporting; clinical affairs, establish and/or remediate Quality Management and documentation systems for GxP compliance; preparation for ISO 13485 registration and CE Mark; and multi-country product registrations and licensing.

Mr. Dills manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations/commercial opportunities. Develops strategies for governmental approval to introduce new products to market, provides guidance and counsel on regulatory requirements, prepares and reviews device submissions [e.g., 510(k), PMA, IDE], including design dossiers and technical files, and other applications/registrations for the Pacific Rim, The Americas and EU. Directs and leads efforts in establishing and retooling QA systems with emphasis on preventing the design, manufacture, and shipment of defective products.

Mr. Dills manages regulatory problems (e.g. AE’s, MDRs, Agency enforcement, and complaints) related to development, manufacturing, and commercialization, and recommends action to senior leadership to ensure effective resolution for manufacturers to achieve sustainable and proven compliant systems. Background encompasses broad capabilities in quality systems, regulatory, design controls and new product introduction, CAPA, software and process validation with compliance oversight, supplier management, and interfaces with FDA and other governmental agencies on the regulatory landscape, strategic compliance with MDD/IVDD Directives, ISO 14971/13485, and demonstrates credible experience to optimize business performance through proactive strategies to mitigate compliance exposure.

Mr. Dills also develops strategies and adds business value to manufacturers by providing strategic and tactical solutions that facilitate the achievement of regulatory and quality milestones and on minimizing delays due to noncompliance. He conducts Compliance Governance Assessments and provides assistance during inspections and with post-inspection correspondence and meetings, involved in the product life cycle and commercialization process and works effectively across all functions for overall corporate compliance to support a company’s goals and strategies.

Mr. Dills analyzes the benefits/risks for informed decision-making; interprets the regulatory precedents and new legislation; understands the competitive landscape; develops the business and regulatory approach; conducts persuasive communication with authorities (FDA and international Agencies); executes an effective path to approval; assists with GxP compliance strategies, effectively coordinates development in multiple markets; selects appropriate testing and manufacturing suppliers; and strives for overall corporate compliance with regulations in The Americas, EU, Pacific Rim and other locales.

Mr. Dills provides direction on understanding the regulatory landscape for the product and provides a fully integrated approach to device development including design controls, and effective communications with Regulatory Authorities related to product development and post-marketing activities.

Mr. Dills has served on the Faculty Advisory Board for the Pharmaceutical Training Institute and currently serves on the Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology and on the Readers’ Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and was nominated and accepted for inclusion into the 2005-2006 Strathmore’s Who’s Who of Professionals.

Mr. Dills has authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter. Mr. Dills’ academic degrees include Environmental Science and Biology. He is a former Chair and Co-Chair of ASQ’s Section 1506 and associated with the Biomedical Division, RAPS, AdvaMed, PDA, ISPE, and other industry working groups.


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