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Introduction

The FDA and its European counterpart, EMA, require drug manufacturers to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance and state of control. This program provides the foundation for an efficient and effective batch record review process and provides pharmaceutical companies with two strategies. First, the key to recognizing what your firm needs to demonstrate control of your manufacturing operations. And, secondly, how to put into place a proactive training regime and batch record review management system.

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Venue

online

online, 201,N Squirrel road,, Auburn Hills, Suite 1007, michigan, 48326, United States

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Organised by

Global Compliance Trainings

Contact information

Mr john gordan
201,N Squirrel road,, Suite 1007, Auburn Hills, michigan, 48326, United States of America
2482120588
Contact us by email

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