Handling OOS Test Results and Failure Investigations

Venue Name: Online Webinar
Number of Attendees: Unknown
Webinar or Virtual Event: Yes
City: Palo Alto
Country: USA
Start Date of Conference: 01-22-2010
End Date of Conference: 01-22-2010
Intended Audience/Keywords: Pharmaceutical and API industry,Laboratory managers and supervisors,GMP auditors,QA/QCU managers and personnel,Qualified persons (for EU compliance),Analysts and other laboratory staff,Regulatory affairs,Human resources (HR) managers and staff,Training departments,Consultants
Description of Conference: This OOS Webinar training will discuss how to handle OOS situations, requirements of ICHQ7A for APIs and how to develop CAPA plans, how to use checklists and forms and how to develop FDA compliant OOS documentation.

Areas Covered in the seminar:

* FDA and international regulations and guidelines.
* FDA's Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.
* Most recent OOS related FDA 483's and warning letters.
* Requirements of ICH Q7A for APIs.
* Developing an effective SOP for OOS situations and laboratory failure investigations.
* Managing formal and informal investigations in laboratories and manufacturing.
* Efficient use of checklists and forms.
* Compliant handling of retests.
* Retesting: what, when and how many times.
* Developing corrective and preventive action plans.
* Strategies to avoid OOS situations BEFORE they occur.
* FDA compliant documentation of OOS, failures investigations and root causes.
Conference Website

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Handling OOS Test Results and Failure Investigations

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