Pharmaceutical Technology - December 2019

Pharmaceutical Technology - Regulatory Sourcebook

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EDITORIAL Editorial Director Rita Peters Senior Editor Agnes Shanley Managing Editor Susan Haigney European Editor Felicity Thomas Manufacturing Editor Jennifer Markarian Science Editor Feliza Mirasol Assistant Editor Lauren Lavelle Senior Art Director Marie Maresco; Graphic Designer Maria Reyes Contributing Editors Jill Wechsler; Hallie Forcinio; Susan J. Schniepp; Eric Langer; and Cynthia A. Challener, PhD Correspondent Sean Milmo (Europe, 485 Route One South, Building F, Second Floor, Iselin, NJ 08830, USA Tel. 732.596.0276, Fax 732.647.1235, SALES Publisher Mike Tracey East Coast Sales Manager Joel Kern Mid West, West Coast Sales Manager BJ Ghiglione European Sales Manager Linda Hewitt European Senior Sales Executive Stephen Cleland Executive Assistant Barbara Sefchick C.A.S.T. Data and List Information Michael Kushner VP/Managing Director, Pharm/Science Group Dave Esola Permissions Alexa Rockenstein, Audience Development Research Director Christine Shappell MJH Life Sciences TM Chairman and Founder Mike Hennessy, Sr Vice Chairman Jack Lepping President and CEO Mike Hennessy, Jr Chief Financial Of ficer Neil Glasser, CPA/CFE Executive Vice President, Operations Tom Tolvé Senior Vice President, Content Silas Inman Senior Vice President, I.T. & Enterprise Systems John Moricone Senior Vice President, Development & Enterprise Systems John Paul Uva Senior Vice President, Audience Generation & Product Fulfillment Joy Puzzo Vice President, Human Resources & Administration Shari Lundenberg Vice President, Business Intelligence Chris Hennessy Vice President, Corporate Branding & B2B Marketing Amy Erdman Executive Creative Director, Creative Services Jeff Brown MultiMedia Pharma Sciences LLC provides certain customer contact data (such as customers name, addresses, phone numbers, and e-mail addresses) to third parties who wish to promote relevant products, services, and other opportunities that may be of interest to you. If you do not want MultiMedia Pharma Sciences LLC to make your contact information available to third parties for marketing purposes, simply call toll-free 866.529.2922 between the hours of 7:30 a.m. and 5 p.m. CST and a customer service repre- sentative will assist you in removing your name from MultiMedia Pharma Sciences LLC lists. Outside the US, please phone 218.740.6477. Pharmaceutical Technology does not verify any claims or other information appearing in any of the adver- tisements contained in the publication, and cannot take responsibility for any losses or other damages incurred by readers in reliance of such content. Pharmaceutical Technology welcomes unsolicited articles, manuscripts, photographs, illustrations, and other materials but cannot be held responsible for their safekeeping or return. Single issues, back issues: Call toll-free 800.598.6008. Outside the US call 218.740.6480. Reprints: Contact Mike Tracey, Display, Web, Classified, and Recruitment Advertising: Contact, tel. 732.346.3027. Permissions: Contact Alexa Rockenstein, tel. 732.346.3007, To subscribe: © 2019 MultiMedia Pharma Sciences LLC All rights reserved. No part of this publication may be reproduced or trans- mitted in any form or by any means, electronic or mechanical including by photocopy, recording, or information storage and retrieval without permission in writing from the publisher. Authorization to photocopy items for internal/educational or personal use, or the internal/educational or personal use of specific clients is granted by MultiMedia Pharma Sciences LLC for libraries and other users registered with the Copyright Clearance Center, 222 Rosewood Dr. Danvers, MA 01923, 978-750- 8400 fax 978-646-8700 or visit online. For uses beyond those listed above, please direct your written request to Permission Dept. or email: Regulatory Sourcebook December 2019 REGULATORY UPDATE 4 Warning Letters Signal Steps to Compliance Rita Peters QUALITY COMPLIANCE 6 Moving From Compliance to Quality Agnes Shanley QUALITY RISK MANAGEMENT 12 Quality Risk Management Plans Create Effective Quality Systems Susan J. Schniepp DESIGN OF EXPERIMENTS 14 Design of Experiments Gains Ground in Biopharma Development Agnes Shanley PHARMACOPOEIA COMPLIANCE SERIES 17 Revision Process for Global/National Pharmacopoeias J. Mark Wiggins and Joseph A. Albanese 26 Surveillance Process for Industry: Monitoring Pharmacopoeia Revisions J. Mark Wiggins and Joseph A. Albanese RESOURCES 38 Regulatory and Standard Setting Organizations 41 Resources, Guidelines, and Guidance Documents 43 Ad Index Cover image: tamayura39 -; Cover design, Maria Reyes

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