How FDA Trains Its Investigators to Review CAPA

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

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• 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.

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• 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.

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• 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

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• 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.

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• 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.

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• 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
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• Get Connected With Us

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