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:

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