Press Release March 13, 2019

Alston & Bird Attorneys Author Chapters in New Book Edition on Pharmaceutical Industry CGMP Compliance

Alston & Bird health care attorneys have authored several chapters in a new edition of a book aimed at helping the rapidly evolving pharmaceutical industry master the governing principles and compliance standards for Current Good Manufacturing Practices (CGMPs).

Partners Cathy Burgess and Dan Jarcho and associates Justin Mann and Seth Olson, members of Alston & Bird’s Health Care Group, contributed three chapters to the book Good Manufacturing Practices for Pharmaceuticals, Seventh Edition, addressing CGMP enforcement alternatives in the U.S. and the U.S. Food and Drug Administration’s inspection process and pre-approval inspections.

Published by CRC Press, the book comprises nearly 400 pages of in-depth guidance on the world of pharmaceutical quality systems and the key elements that must be in place to change the business and truly integrate quality business systems that are self-detecting and correcting.

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