Alston & Bird Attorneys Author New Book on Pharma CGMP Compliance

Alston & Bird’s Cathy Burgess and Dan Jarcho, partners in the firm’s Health Care Group, have written a new book to help the rapidly evolving pharmaceutical industry master the governing principles and compliance standards for Current Good Manufacturing Practices (CGMPs).

Published by the Food and Drug Law Institute, How to Comply With Drug CGMPs provides extensive analysis of the legal and regulatory framework for CGMPs. It is a practical, concise, user friendly resource on how the U.S. Food and Drug Administration (FDA) evaluates drug manufacturers’ compliance, the consequences of noncompliance, how to remain current with CGMPs, and how to incorporate them into a robust compliance program.

How to Comply With Drug CGMPs draws on the direct experience of Burgess and Jarcho in successfully representing global pharmaceutical clients regarding quality manufacturing issues before the FDA.