Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems

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This is a Core Course for the following Certification Track(s):

  • Global Regulatory Affairs Compliance Professional (GRACP)™

  • COURSE DETAILS

    Course Description

    As users and regulatory agencies are becoming less ‘tolerant’ of medical device failure, regulatory agencies are placing greater emphasis on post market surveillance as a way to improve risk management and protect public health. This course will review the regulatory expectations for post market surveillance and outline how to apply the requirements to medical devices. Topics include: complaint handling & vigilance systems, Medical Device Reports (MDR), implementation challenges, medical device tracking, impact of post approval studies, compliance requirements & meeting them, and complaint systems inspections.

    Throughout the course, examples and case studies will help participants apply the concepts being covered.

    Who Should Attend

    This course will be of great value to medical device professionals involved in post market surveillance/complaint handling. It is primarily designed to benefit the following disciplines and personnel:

    • Post Market Surveillance
    • Complaint Assessment & Handling
    • Quality Assurance
    • QMS & Compliance Management
    • Risk Management
    • Regulatory Affairs
    • Clinical Affairs
    • Medical Directors
    • Manufacturing
    • Research and Development
    • Recall Coordinators

    Learning Objectives

    By the end of this course, participants will:

    • Know the requirements of post market surveillance
    • Understand the similarities & differences between FDA & EU requirements
    • Know the requirements for compliant & effective complaint handling
    • Understand the differences between feedback, complaints & reportable events
    • Know how post approval studies impact post market surveillance requirements
    • Understand the compliance requirements & practical needs for medical device tracking
    • Understand how Quality System requirements are linked to post market surveillance
    • Understand the importance of decision making, escalation & timeliness
    • Understand the challenges of implementing a compliant & effective complaint handling system

    Participant Comments

    "Very knowledgeable, communicative, experienced instructor. Great take home sources, CD, mini books, etc. Great real-life examples were shared and discussed. Good sense of humor. Very good coordination of visual aids, flow charts, etc. Good Q/A schedules." Tasneem A., QS Auditor, NDC
    "Instructor 'went the extra mile' by adding Recall discussion to address a student's question. I really liked his approach to asking everyone what they wanted to learn and then following up to make sure everyone's objectives were met. This was an excellent technique." Lynn B. Director of Quality, IOGYN
    "Jonathan Lee was a very knowledgeable and engaging speaker. Wealth of information for us to consider and take in as we set up our new complaint handling systems." Arleen F. VP Quality, Argos Surgical

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