Engaged. Knowledge. Application
Warning Letter Prevention Power Package
CAPA, Complaint Handling and Failure Investigation violations are on the majority of Warning Letters issued by FDA recently for both pharmaceutical and devices (See an excerpt from a current warning letter below).
Help ensure your company's compliance with these regulations.
You receive 24+ content resources, including:
- 5 Webinar Recordings
- 5 PowerPoint training presentations
- 4 Auditing checklists
- 4 articles
- 2 SOPs
- And more
This package is a combination of the following packages:
- CAPA CONTENT Power Package -to view complimentary excerpts click here
- Complaint Handling CONTENT Package - to view complimentary excerpts click here
- Failure Investigation CONTENT Package - to view complimentary excerpts click here
Save over 20% if purchased separately.
This package is available for 7 days only - offer expires February 24, 2011 midnight.
Order yours now in the enkap store - click here
Recent
Warning Letter Excerpt
Southern Implants, (Pty.) Ltd. ... February 7, 2011
Multiple CAPA, Complaint Handling and Failure Investigation violations. Excerpts from this warning letter include:
"Not all quality data sources are being monitored...to identify sources of nonconformance for corrective actions."
"...no documented investigation to determine the root cause."
"Your firm did not provide documentation...to ensure that corrective and preventive action are implemented as required."
Customer complaint: "The complaint was confirmed and the staff retrained but there was no documented investigation to determine the root cause."
View other examples and excerpts from Warning Letters - Click here
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