How FDA Trains its Investigators to Review CAPA - 2017

What topics are covered by the course?

Documents Used by FDA Inspectors
Investigations Operations Manual (IOM)
CPG Manual 7382.845
QSIT Manual

Who should attend?

QA management
CAPA coordinator
Regulatory Affairs management
Executive management
Consultants

What will I be able to do on completion?

How your company can use that same document to increase the likelihood of a positive outcome during the inspection.

How will I be assessed?

Full Details & Registration Link:
http://www.compliance4all.com/control/w_product/~product_id=501265LIVE?channel=coursesplus_May_2017_SEO

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

Guide Price: $ 150

Delivery: Online
Category: Health & Medical »
Duration: 10:00 AM to 11:00 AM
Qualification: N/A

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