GMP Training Class: FDA Compliance during Pharmaceutical Process Development

Compliance: Proc. Development

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:

	Regulatory Requirements
	Use of Scaled Down Models
	Raw Material Issues
	Tolerances and Uncertainties
	Assay Issues
	Scale-up Issues
	Technology Transfer
	Quality Assurance Involvement

Back to Training

Rates

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.

	Copyright 2003 Compliance Net, Inc.
	Home \| Contact Us