How FDA Trains its Investigators to Review CAPA - 2017
The documents used by FDA to train their inspectors to review your CAPA system.
Sun, May 14, 2017 10:00 AM (PDT)
Online,
Fremont,
California
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Details
This event ended
Sun, May 14 - 11:00 AM
Overview:
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 to increase the likelihood of a positive outcome during the inspection.
Areas Covered in the Session:
Documents Used by FDA Inspectors
Investigations Operations Manual (IOM)
CPG Manual 7382.845
QSIT Manual
Who Will Benefit:
QA management
CAPA coordinator
Regulatory Affairs management
Executive management
Speaker 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.
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com
Full Details & Registration Link: http://www.compliance4all.com/control/w_product/~product_id=501265LIVE?channel=ticketprinting_May_2017_SEO
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 to increase the likelihood of a positive outcome during the inspection.
Areas Covered in the Session:
Documents Used by FDA Inspectors
Investigations Operations Manual (IOM)
CPG Manual 7382.845
QSIT Manual
Who Will Benefit:
QA management
CAPA coordinator
Regulatory Affairs management
Executive management
Speaker 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.
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com
Full Details & Registration Link: http://www.compliance4all.com/control/w_product/~product_id=501265LIVE?channel=ticketprinting_May_2017_SEO
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Online
Online
Fremont,
California
94539