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Live -Webinar 2014 - Batch Production Record and Device History Record Review and Quality Assessment
Topics/Call fo Papers
DESCRIPTION
Typical Elements Required to be Included in the Batch Production Record and the Device History Record in order to Accomplish a Quality and Cost Effective Review and Quality Assessment based on current Regulatory Expectations.
Why should you attend
A vast majority of the current industry deficiencies which have led to isolated 483s, Warning Letters and Consent Decrees are the result of deficient technical documentation of the production processes for both injectables, devices and solid dosages.
Typical Elements Required to be Included in the Batch Production Record and the Device History Record in order to Accomplish a Quality and Cost Effective Review and Quality Assessment based on current Regulatory Expectations.
Why should you attend
A vast majority of the current industry deficiencies which have led to isolated 483s, Warning Letters and Consent Decrees are the result of deficient technical documentation of the production processes for both injectables, devices and solid dosages.
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Last modified: 2014-07-22 14:33:43