FDA Warning Letter - Consent Decree Software Validation

Venue Name: Online Webinar
Number of Attendees: Unknown
Webinar or Virtual Event: Yes
City: Palo Alto
Country: USA
Start Date of Conference: 01-27-2010
End Date of Conference: 01-27-2010
Intended Audience/Keywords: Internal auditors,External auditors,Remediation personnel,Quality Assurance personnel and management,SQA - Software Quality personnel,Consultants,Business managers responsible for system compliance,IT / IS managers,Regulatory affairs personnel and management,Third-party certifier personnel
Description of Conference: This FDA warning letter Webinar/training will discuss what to do to avoid additional software related compliance along with the response steps where the citations that directly or indirectly include automated system.

Areas Covered in the seminar:

* Outline of FDA regulations as applied to software.
* Review of FDA software validation requirements.
* Review of FDA software expectations.
* Proactive steps to prevent additional software-related compliance and enforcement problems.
* Response steps where inspection citations directly or indirectly include automated systems.
* Forward planning.
* What to do about existing systems.
* The paradox of ongoing validation work.
Conference Website

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FDA Warning Letter - Consent Decree Software Validation

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