Course Description:

When done correctly, information from risk management programs and post market surveillance activities should be fed into the product development life cycle activities to incrementally improve the design of every medical device. Unfortunately, the endeavor to link these potentially disparate programs and groups within a company can be an extremely costly activity when done incorrectly or poorly.

Many companies today have a risk management process including a risk management plan (RMP) which evaluates the product during development and a separate post market surveillance plan (PMSP) to collect reports of problems with devices already on the market. But in many cases information collected under the PMSP is rarely incorporated into the RMP in an integrated way which can lead to the required design changes in an expedient and efficient way when the risks reach the “tipping point.” By utilizing the knowledge generated from the integration of two disparate processes together, a robust system must be created to identify the “tipping point” and to anticipate the appropriate design changes which may be required to keep the product safe and effective to perform as intended.

The goal of these relatively new integrated programs is to develop a knowledge base within the company which assesses and proactively stores both benchtop and real world medical device use experience and feedback (i.e. corporate knowledge base about the device) and also assessments of reported issues for quick and easy use.

During this 1 ½ days seminar , attendees will gain an in depth understanding of risk management planning and post market surveillance planning strategies with an emphasis on how the two can be integrated together. A review of the FDA guidance for RMP and PMSP information will be covered and case studies will highlight how to integrate the knowledge gained from RMPs and PSMPs and to translate it into beneficial device design changes.

Learning Objectives:

  • Review of risk management regulatory requirements, guidance documents and the process to develop a RMP.
    • ISO 14971.
    • Guidance for Industry: Q9 Quality Risk Management.
    • Guidance for Industry and FDA Premarket and Design Control Reviewers: Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management.
    • Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments and Proposed REMS Modifications.
  • Review of post market surveillance regulatory requirements, guidance documents and the process to develop a PMSP.
    • 21 CFR 822 Post Market Surveillance.
    • Guidance for Industry and FDA Staff- Postmarket Surveillance Under Section 522 of the Federal Food, Drug and Cosmetic Act.
  • Discuss ways to align and integrate information from RMP and PMSP activities to create a robust documented knowledge base.
  • Understand anticipated pain points when integrating the knowledge base acquired from the integrated RMP and PMSP activities with required device design change processes.
  • Understand how specific required information and knowledge management tools (like documented SOPs, work instructions and forms) can assist in improving product design.
  • Understand how to evaluate the potentially required device design changes due to changes in the expected device risk profile resulting from the integrated RMP and PMSP knowledge base (i.e. how to rank issues which might lead to required device design changes as a way to prioritize device design changes).
  • Discuss ways to create and use a robust knowledge system designed to lead to device design changes as quickly as possible when necessary as part of the device development life cycle program (i.e. how to improve product design change management).

Who will Benefit:

  • Project Managers
  • Regulatory Affairs Manager
  • Compliance Managers and Specialists
  • Risk Management
  • Quality Assurance Managers
  • Design Control Managers

Course Outline:

Day One     Day Two

  • Introductions - 15 Min
    • Instructor
    • Participants
  • Session 1: Overview of Risk Management and Post Market Surveillance - 30 Min
  • Session 2: Risk Management - 75 Min
    • Review of guidance
    • Use of ISO 14971
    • Risk management plans
    • Risk/Hazard identification process
    • Types of Risk Management documents (dFMEA, pFMEA, Use/Risk, etc...)
    • Reporting Requirements
  • Break - 30 Min
  • Workshop: Development of a risk management plan - 90 Min
  • Lunch - 60 Min
  • Session 3: Post Market Surveillance - 75 Min
    • Review of guidance
    • Post Market Planning
    • Sources of post market information
    • Internal, External and Routine activities
    • CAPA
    • Reporting Requirements
  • Break - 30 Min
  • Workshop: Developing a post market surveillance plan - 60 Min
  • Session 4: Integration of RMP with PMSP - 30 Min
    • How do they complement one another
    • Quality Management System document revisions
    • Departmental collaborations

  • Day 1 Recap - 15 Min
  • Workshop: Rewriting Documents- Integration of PMS information into RM process - 60 Min
  • Session 5: Product Development - 45 Min
    • Evaluation of risk to design from PMS knowledge
    • Change management- Integration in real time
  • Break - 30 Min
  • Case Study: Using PMS findings to improve future device design - 45 Min
  • Q&A and Conclusions - 45 Min

Meet Your Instructor

Dr Joy Frestedt
President and CEO of Frestedt Incorporated

Dr. Frestedt is President and CEO of Frestedt Incorporated, a virtual Contract Research Organization including a corporate network of over 70 experts and highly skilled staff meeting specific needs in regulatory, clinical and quality affairs. Dr. Frestedt has over 30 years of experience in the health care, pharmaceutical, medical device and food-related industries assisting firms with strategic decisions involving clinical trials, successful regulatory negotiations and the development of quality management systems to compete globally. She has held key positions at Johnson and Johnson's Ortho Biotech, Medtronic, Mayo Clinical Trial Services, AstraZeneca Pharmaceuticals and Orphan Medical providing leadership and management for the development of pharmaceutical, medical device and food products.

Dr. Frestedt holds a BA in biology from Knox College and a PhD in pathobiology from the University of Minnesota Medical School. She is a member of the American Society of Clinical Oncologists, American Association of Pharmaceutical Scientists, Society of Clinical Research Associates, Association of Clinical Research Professionals (where she served as past chapter president and on the Editorial Advisory Board), and she is a Fellow and past chair of the ethics committee for the Regulatory Affairs Professionals Society. Dr. Frestedt recently founded Alimentix, the Minnesota Diet Research Center, was named interim Regulatory Director for the University of Minnesota Academic Health Center and she is one of the “100 Most Inspiring People in the Life Sciences Industry” by PharmaVOICE, 2011 as well as one of the top 25 “Industry Leaders” a “Women in Business Award” by the Minneapolis/St. Paul Business Journal, 2011.

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