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Documentation
Course Summary
Comprehensive documentation of procedures, formulas, work instructions, and specifications, and thorough recording of batch data, are fundamental requirements of GMP. In this short course we explain why documentation is so important, identify different types of document required, and set out some simple rules for recording and correcting data.
Purchasing Information
When you have completed your course order, Zenosis will finalise the setup of your course materials and contact you on the email address that you provide in your order. You can expect this process to be completed within one business day (using the UK business calendar) of completing your payment.
It is therefore essential that you use your real email address for your order, or indicate in the purchase notes the email address to be used for the course set-up, and check that any messages from Zenosis or grapl are not lost in your junk or spam folder.
You will have access to the course module(s) for a period of 180 days after your purchase is complete.
Detailed Course Information
Learning Objectives
• Give reasons why documentation is so important
• Identify types of documents required under GMP
• Outline requirements for instruction documents
• Outline the contents of batch records and requirements for their retention
• Follow good practice in recording and correcting data
• Identify sources of regulations and guidance on computerised systems, electronic records and signatures
Who will benefit from this course
Everyone who works in, or has occasion to enter into, a manufacturing environment in the pharma/biotech industry should have access to this module.
Module Outline
Roles
Manufacturing personnel
CPD Points
No
Region
Level
Foundation
Course Study Time
Approx 30 minutes
USA, Europe, Other