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Auditing for Quality Manufacturing: Five Areas of Risk for Drug and Device Manufacturers

May 6, 2020

This management report will help you prepare, organize and streamline your audit approach so you can identify quality issues to establish a more robust operation that stands up to regulatory scrutiny.

Core Processes in the Pharmaceutical Laboratory: EU GMP-Compliant Sampling and Handling of Substances

May 6, 2020

Complying with good manufacturing practices (GMP) is mandatory for your drug’s success – sampling, testing and packaging materials all need to meet stringent regulatory standards. Set yourself up for EU success with this management report.

Risk Management for Drug and Device Manufacturers: A Guide to FDA Policies and Processes

April 24, 2020

Without a good overview of the latest risk guidances, you may not know how to readily identify potential hazards, apply proper risk evaluation requirements or conduct pre- and postmarket assessments of your drug products and medical devices. This guide has more than 400 pages of FDA requirements and 20 specific documents that include guidances, statements and policies.

GCP Questions, FDA Answers - 2019 Edition

April 24, 2020

This collection of questions submitted to the FDA’s Office of Good Clinical Practice sheds light on some of the most difficult and important topics in clinical trial research.

EU-Compliant Batch Release of Medicinal Products: How to Meet the Requirements of Annex 16 of the EU GMP Guide

April 24, 2020

In this guide, you'll get a step-by-step walkthrough of the batch release process and what EU GMP guidelines apply, written by a recognized European GMP expert.