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Compliance: Proc. Development

 
 

Auditing Biopharma APIs
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Process Validation
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Compliance: Proc. Development
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Intro to GMPs
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Process Val Overview

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cGMP Defined

 

 

 

Building in Compliance in Process Development:
Lab Bench to Market Production 

Approximate Time: 2 hours

Who Should Attend:

This course is designed to provide an overview of issues regarding GMP compliance during Process Development.  Personnel in QA, Process Development, QC, and Regulatory involved in ensuring GMP compliance and robust FDA submissions should attend. Course assumes the attendee has a basic understanding of the GMP regulations. 

Course Description: 

Many don't consider it necessary to follow GMPs during Process Development.  This course will show you which GMPs make sense to apply early and how taking these step will save you significant development time as your product advances towards market.  Following these key principles will also ease the effort involved in Process Validation. This course will detail where to spend limited resources to get the most benefit.  Course Topics include:

bulletRegulatory Requirements
bulletUse of Scaled Down Models
bulletRaw Material Issues
bulletTolerances and Uncertainties
bulletAssay Issues
bulletScale-up Issues
bulletTechnology Transfer
bulletQuality Assurance Involvement

 

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 How to ensure that Process Development work can be captured in a GMP compliant manner so it can be used to support product filing claims and process validation.

 

GMP in Process Development

Data generated at laboratory scale is not required to meet GMP regulations and guidelines, however the work must be adequately documented for review during a PreApproval Inspection and there must be sufficient confidence in the numbers generated, particularly with respect to uncertainty of those measurements at laboratory scale.

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