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Conference Directory
Why we need an effective Equipment Program? Implement USP <1058>
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Venue Name: Online Event
Country: United States of America
City: Palo Alto
State: CA
Number of Attendees: Unknown
Webinar or Virtual Event: No
Keywords: QC Supervisors and Management,QC personnel,QA personnel,QA Management,Documentation management specialists,Regulatory affairs personnel,R&D Lab personnel,R&D Lab Supervisors
Start Date of Conference:: 04-08-2010
End Date of Conference: 04-08-2010
Description of Conference: Why Should You Attend:
An effective Equipment Program is needed in order to provide confidence in the data generated by the laboratory which support 'go/no-go' project decisions. It is also a key FDA expectation in as early as Phase I clinical studies. Laboratory Controls, including the Lab Equipment Program continues to be a major focus area during FDA inspections and deficiencies in this area continue to be sited often in 483s and warning letters.
This webinar will begin with an overview of Regulatory Requirements for Pharmaceutical Laboratory Equipment Programs. Requirements for Design Qualification, Installation Qualification, Operational Qualification and Performance Qualification as per USP will be discussed in detail. Industry Best Practices for an effective Preventative Maintenance/ Calibration Program, and how to meet requirement efficiently in small and large laboratories will be discussed. Recent inspection trends related to the equipment program as reflected in recent 483s and warning letters, and practical means to prevent such deficiencies will be addressed.
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Why we need an effective Equipment Program? Implement USP
