How FDA Trains Its Investigators to Review CAPA - PowerPoint PPT Presentation

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How FDA Trains Its Investigators to Review CAPA

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This session will discuss all the documents used by FDA to train their inspectors to review your CAPA system, some of which you may not be familiar with. – PowerPoint PPT presentation

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Title: How FDA Trains Its Investigators to Review CAPA


1
  • How FDA Trains Its Investigators to Review CAPA,
    What You Can do to Prepare Complaint Handling in
    Compliance with FDA and ISO Regulations

www.onlinecompliancepanel.com 510-857-5896
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2
  • Instructor Profile
  • Jeff Kasoff, RAC, is the
    Director of Quality at Byrne Medical, a leading
    manufacturer of endoscopy and colonoscopy
    devices, where he oversees the operation of the
    quality system. In this position, Jeff is
    responsible for oversight of the document control
    system, including maintenance of regulatory
    documentation.
  • Prior to this, Jeff spent 13 years at
    Life-Tech, Inc. as the Director of Regulatory
    Affairs, where he was responsible for compliance
    of the corporate quality system. Jeff received
    his regulatory affairs certification in 1996.

www.onlinecompliancepanel.com 510-857-5896
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3
  • Description
  • During an inspection, FDA
    personnel will take a great deal of time
    reviewing your company's CAPA system. What will
    they look for? This session will discuss all the
    documents used by FDA to train their inspectors
    to review your CAPA system, some of which you may
    not be familiar with.
  • Also contained in this session will be a
    section-by-section summary of the CAPA subsection
    of the QSIT, the document by which FDA inspectors
    operate during an inspection, as well as how your
    company can use that same document in your
    preparation.

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
4
  • Why Should you Attend?
  • This webinar will provide
    valuable assistance to all regulated companies,
    since a CAPA program is a requirement across the
    Medical Device, Diagnostic, Pharmaceutical, and
    Biologics fields. 
  • Who can Benefit?
  • The employees who will benefit include
  • RD Management
  • Regulatory management
  • QA management
  • Consultants
  • Quality system auditors

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
5
  • Objectives of the Presentation
  • The objectives of the presentation
    are to deal with
  • Documents Used by FDA Inspectors.
  • CAPA Implications of Investigations Operations
    Manual (IOM), and Recommended Methods of
    Compliance for each Requirement
  • CAPA Implications of CPG Manual 7382.845, and
    Recommended Methods of Compliance for each
    Requirement.
  • QSIT Manual Description of each CAPA
    Inspectional Objective, and Recommended Methods
    of Compliance.

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
6
  • Live Session - How it 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.

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
7
  • Recorded Session - How it 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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