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
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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.
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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.
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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
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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.
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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.
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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.
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customersupport_at_onlinecompliancepanel.com
8www.onlinecompliancepanel.com
www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com