Complaint Files, Procedures and Interrelationship with Complaint Handling, CAPA, Change Control, Adverse Event Reporting and Recalls - PowerPoint PPT Presentation

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Complaint Files, Procedures and Interrelationship with Complaint Handling, CAPA, Change Control, Adverse Event Reporting and Recalls

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In this webinar the speaker discuss about the regulatory compliance for complaint handling in various industries like pharmaceutical, medical device. – PowerPoint PPT presentation

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Title: Complaint Files, Procedures and Interrelationship with Complaint Handling, CAPA, Change Control, Adverse Event Reporting and Recalls


1
  • Complaint Files, Procedures and Interrelationship
    with Complaint Handling, CAPA, Change Control,
    Adverse Event Reporting and Recalls

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
2
  • Instructor Profile
  • Ms. Vanessa Lopez has
    held a wide variety of leadership roles in the
    Medical Device (Class I, II, and III),
    Pharmaceutical (API Finished Product) and
    Environmental regulated industries as well as the
    Consulting Services industry. She has worked for
    Edwards LifeSciences, Roche Diagnostics, Eli
    Lilly, Pall LifeSciences, among others. She
    possesses over 20 years of experience focused on
    development, implementation, driving improvements
    and monitoring of Quality Assurance, Quality
    Control, Regulatory Compliance, Regulatory
    Affairs, Quality Systems and Supplier Quality
    activities.
  • Ms. Lopez has in-depth knowledge, coaches
    on interpretation and application of US
    regulations, EU directives, specific country
    regulations (Japan, Canada, and others),
    national/international standards and guidance
    documents. She has also held positions within the
    CAPA, Material, Safety and Management Review
    Boards as well as others.

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
3
  • Description
  • The course will touch on
    complaint sources, and details will be furnished
    on the interrelationships regarding Complaint
    Handling/Change Control/Adverse Event
    Reporting/and Recalls. The course will also
    include timeline requirements associated with
    adverse event reporting, which reporting formats
    to use, when to recall and types of recalls.
  • In addition, the webinar will incorporate
    the Complaint Handling Life-Cycle Process and an
    example of activities involved in this life
    cycle. This webinar will discuss complaint
    handling implementation challenges, in addition
    to pitfall challenges.
  • At the end of this webinar, there will be
    a conclusion section, where points to take into
    account with the integration of CAPA/Change
    Control/Adverse Event Reporting/Recalls/Complaint
    Files in the Complaint Handling Life-cycle, will
    be detailed.

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
4
  • Benefite of attending the webinar
  • By attending this webinar
    you will be provided with detailed information to
    help you gain a better understanding of the
    requirements of a complaint handling system and
    the interrelationship other regulated activities
    have with the referred system. In addition, it
    will walk you through the complaint handling
    life-cycle process by providing you an example of
    actual activities during this cycle.

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
5
  • Objectives of the Presentation
  • The following topics will be addressed during
    this webinar
  • Medical Device and Drug Complaint Handling
    Requirements (US)
  • Complaint Sources
  • Interrelationship of Complaint Handling, CAPA,
    Change Control, Adverse Event Reporting and
    Recalls
  • Reportable Events, Voluntary and Mandatory
    Reports, and Reporting timelines
  • Complaint Handling Life-Cycle Process (including
    an example that embraces activities related to
    bullet three, above)

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
6
  • Who Can Get Benefited
  • People who are into
    Regulatory Compliance Professionals, Quality
    Assurance Professionals, Quality Control
    Professionals, Regulatory Affairs Professionals,
    Complaint Handling Professionals, Quality
    Engineers, Service Technicians and Engineers,
    Manufacturing and Design Engineers, Process
    Development Personnel, Customer Service
    Personnel, Sales Representatives will be more
    benefited by attending this webinar.

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
7
  • How Live Session Works ?
  • Username and Password will be sent to you 24
    hours prior to the webinar
  • Presentation handouts in pdf format will be
    mailed to you
  • Login to the session using the username and
    password provided to you
  • Get answer to your queries through interactive
    QA sessions via chat
  • Get certification of attendance.
  • How Recorded Session Works ?
  • A link will be provided to you upon purchase of
    the recorded session
  • Please click on the link to access the session
  • Presentation handouts in pdf format will be
    mailed to you
  • Get certification of attendance.

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
8
  • Get Connected With Us

www.onlinecompliancepanel.com
www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
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