compliance  +  regulatory  +  training
Products - Publications
 

Dr. Wagner is a recognized author and presenter on the topics of regulatory compliance, technology transfer and process controls. She has also taught several courses for PDA, ISPE, DIA and FDANews. She currently shares her expertise by teaching in-house seminars and workshops, or by organizing special topic meetings such as the conferences for the Biofilm Networking Group, which she co-founded in 2007.

Dr. Wagner has been an author of several book chapters and editor of several publications. A few of these books are highlighted below:

Dr. Wagner and Dr. Clontz started the Biofilm Networking Group in 2007. Their efforts to bring attention to this important topic lead them to also develop workshops on this subject. Their passion for educating the industry on the importance of Biofilms in contamination control of pharmaceuticals culminated with the publications shown below:

Biofilm Control in Drug Manufacturing Hardcover from $299.00 on Amazon - 2012
by Lucia Clontz (Editor), Carment M. Wagner (Editor),
PDA Bethesda, MD, USA DHI Publishing, LLC River Grove, IL, USA
This book provides guidance in preventing and controlling Biofilm contamination in pharmaceutical and biopharmaceutical processing. Twelve chapters contributed by global experts and useful appendices cover topics such as the Contamination Control by Design Model, the impact of biofilms on pharmaceutical manufacturing, establishing microbial contamination control , controlling biofilms in drug manufacturing equipment, the link between process equipment colonization and drug safety, detection, prevention and control of biofilms in pharmaceutical water, sanitization and much, much more.
2001, 25 pages.




PDA Technical Report No. 69
Bioburden and Biofilm Management in Pharmaceutical Manufacturing Operations

(Dr. Wagner contributed to the report together with other experts)
PDA Technical Report No. 69, (TR 69) Bioburden and Biofilm Management in Pharmaceutical Manufacturing Operations presents the current scientific understanding of the causes of and control strategies for bioburden in pharmaceutical production systems, with a special emphasis on biofilms in fluid-handling systems. It encompasses pharmaceutical and biopharmaceutical manufacturing processes, but does not include the final aseptic and terminal sterilization fill-finish operations.
Price: Member: $150, Non-member: $325, Government: $150




Biotechnology: Quality Assurance and Validation
Kenneth E. Avis, Carmen M. Wagner, Vincent L. Wu
Biotechnology: Quality Assurance and Validation provides a practical, detailed discussion of what issues Quality Assurance and Quality Control need to identify for effective control in the preparation of biotechnology products. The book presents a series of topics that define some of the unique challenges facing biotechnology companies in producing biopharmaceutical products. The topics selected address quality and validation issues, starting with the cryopreservation of cell lines through the filling and finishing of the product. It includes a validation guide, a clear presentation of how to use filtration effectively, a synoptic view of cleaning procedures, and much more.
  • Published October 31, 1998 by CRC Press
  • 288 Pages
  • ISBN 9781574910896 - CAT# PH0892




Cryopreservation: Applications in Pharmaceuticals and Biotechnology
Edited by Kenneth E. Avis, Carmen M. Wagner
This book covers the principles of cryopreservation as they relate the preservation of viable cells and cell materials being developed for biopharmaceutical applications. Topics include: the principles of freezing and thawing cells, physiochemical phenomena, process and system design options.
  • Published September 30, 1999 by CRC Press




Biotechnology: Quality Assurance and Validation
Edited by Kenneth E. Avis, Carmen M. Wagner, Vincent L. Wu
Biotechnology: Quality Assurance and Validation provides a practical, detailed discussion of what issues Quality Assurance and Quality Control need to identify for effective control in the preparation of biotechnology products. The book presents a series of topics that define some of the unique...
  • Published October 31, 1998 by CRC Press




Practical Aseptic Processing: Fill and Finish, Volume I and II
Edited by Jack Lysfjord
Aseptic Processing technology has changed with the use of Advanced Aseptic Processing techniques such as: Blow fill seal (BFS) isolators and Restricted Access Barrier Systems (RABS). By becoming informed of the current state of the art, product contamination can be greatly improved. More than 30 global subject matter experts contribute invaluable pragmatic knowledge to this pursuit.
Price: Member: $425, Non-member: $530, Government: $260




Dr. Carmen M. Wagner was the founder and Chair of the first Isolator Technology Users Group. She edited the first book on Isolation Technology in 1995. She is also one of the authors of this technical report:

PDA Technical Report No. 34
Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products
This technical report addresses essential user requirements for the application of isolator technology to a broad range of manufacturing, development and testing applications in the health care product manufacturing industry.
2001, 25 pages.
Price: Member: $75, Non-member: $150, Government: $30




In the late 90's Dr. Carmen M. Wagner participated in the Cleaning Validation Task Force which gave birth to this technical report:

PDA Technical Report No. 29
Points to Consider for Cleaning Validation
This document provides guidance on the validation of cleaning for a broad range of processing systems and product types within the pharmaceutical industry - including perspectives on the application of cleaning validation guidance in the areas of finished pharmaceuticals, bulk pharmaceutical chemicals, biopharmaceuticals and clinical products.
1998, 23 pages. Available in digital file only.
Price: Member: $75, Non-member: $150