Webinar · Palm Beach, Florida
How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare
Health · Medicine · Pharmaceuticals
Key numbers
- Editions on record
- 1first in 2014
About How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare
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.
Areas Covered in the Session:
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
Who Will Benefit:
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. The employees who will benefit include:
R&D Management
Regulatory Management
QA Management
Consultants
Quality System Auditors
From our listing of this edition. Details may have changed since.
Editions
| Year | Dates | Where | Exhibitors | Visitors |
|---|---|---|---|---|
| 2014 | 27 Aug 2014 | Webinar Venue Online | — | — |
Past editions from the bvents archive (2008–2019) and organiser figures where they were published.
Questions
When is How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare?
The next dates haven't been confirmed. The last edition we have on record was 27 Aug 2014.
Where is it held?
The last edition we have was at Webinar Venue, Palm Beach, Florida.