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Quality Management

Regulatory requirements, scientific basics and practical implementation proposals around the topic quality management.

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Packaging Materials for Pharmaceutical Products

Handling packaging materials is a high-risk business because of the danger of mix-ups. Get to...

€117.00 net

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Core Processes in the Pharmaceutical Laboratory

GMP-Conform Sampling and Handling of Substances regulatory requirements methodological...

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The Road to a Pharmaceutical Quality System

A step-by-step guide to bring your drug manufacturing systems into compliance!

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Quality Agreement

This sample document defines framework conditions and processes between contract givers and...

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EU-Compliant Batch Release of Medicinal Products

How to Meet the GMP Requirements of Annex 16 EU GMP Guide Batch release is complex and...

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Failure Management in a GMP Regulated Environment

How can occured failures be avoided in the future? Start to treat the root cause, not the...

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A Successful Concept for Technology Transfer in Drug Manufacturing

This e-book covers all aspects you have to consider when transferring! incl. an example of a...

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Data Integrity in the EU

Nowadays all regulatory authorities focus on data integrity and have their own data integrity...

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Technical Agreement and Delimitation of Pharmaceutical Responsibilities

This SOP helps you to create and describe contracts correctly. Standard draft to adapt and extend

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How to Manage Corrective and Preventive Actions (CAPA) in a GMP Environment

This e-book shows how you can establish an effective CAPA system, which interfaces there are to...

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Successful Implementation of Electronic Document Management Systems

Various different aspects must be considered in order to transfer documentation management,...

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Electronic Batch Recording for Drugmakers

Introducing and implementing an EBR system requires systematic analysis, definition and...

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How to design a Laboratory Data Management System

The introduction of a LDMS has an extremely positive impact on the efficiency and quality of the...

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