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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.

The EU-MDR Transition: Meeting the CE Mark Deadline

April 24, 2020
This management report explains how to take advantage of what the EU is calling a “soft transition” to its new medical device regulation. It breaks down all the rules and explains all the implications of a soft transition, providing a path to follow to full compliance.

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.

2019 - Parts 1300-End (DEA and Office of National Drug Control Policy)

April 24, 2020

2019 - Parts 800-1299 (FDA, Medical Devices)

April 24, 2020

2019 - Parts 600-799 (FDA, Biologics; Cosmetics)

April 24, 2020

2019 - Parts 500-599 (FDA, Animal Drugs, Feeds and Related Products)

April 24, 2020

2019 - Parts 300-499 (FDA, Drugs for Human Use)

April 24, 2020

2019 - Parts 200-299 (FDA, Drugs: General)

April 24, 2020

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