Environmental Monitoring, Volume 1: Establishing the Process (single user digital version)

Table of Contents:

Click here to download >>>Detailed Table of Contents

1. The Use of Risk Management in Environmental Monitoring by Karen Ginsbury. (Chapter excerpted from Environmental Monitoring: A Comprehensive Handbook, Volume 4, Chapter 3 published 2010.)
2. Environmental Monitoring: A Practical Approach by Tim Sandle. (Chapter excerpted from Environmental Monitoring: A Comprehensive Handbook, Volume 6, Chapter 2 published 2012.)
3. Environmental Monitoring of Microbiology Laboratories by Frank Settineri. (Chapter excerpted from Environmental Monitoring: A Comprehensive Handbook, Volume 5, Chapter 1 published 2011.)
4. Designing and Validating a Contamination Control Program by Sandra A. Lowery and Maureen Mueller. (Chapter excerpted from Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded, Volume 1, Chapter 9 published 2008.)
5. Environmental Monitoring and the Microbial Control Strategy by Karen Ginsbury. (Chapter excerpted from Environmental Monitoring: A Comprehensive Handbook, Volume 5, Chapter 7 published 2011.)
6. Developing an Environmental Monitoring Program by Barry A. Friedman. (Chapter excerpted from Environmental Monitoring: A Comprehensive Handbook, Volume 6, Chapter 3 published 2012.)

About the Authors

Karen Ginsbury is a pharmaceutical consultant with more than 20 years of hands-on experience in the pharmaceutical industry. She started her career taking environmental monitoring samples on the factory floor and has been involved in designing, auditing and rationalizing EM programs for companies around the globe. Karen holds a first degree in pharmacy and a Masters of Science in Microbiology, both from the University of London, England.

Dr. Tim Sandle is the Head of Microbiology at the UK Bio Products Laboratory. His role involves overseeing a range of microbiological tests, batch review, microbiological investigation and policy development. Tim has over 20 years experience of work in the scientific and pharmaceutical fields. He serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards), and has acted as a spokesperson for several microbiological societies. He is a committee member of the UK and Irish Microbiology Society Pharmig and editor of the organization's newsletter. Tim has written over 200 book chapters, peer reviewed papers and technical articles relating to microbiology. In addition, Tim runs an online microbiology website (www.pharmamicro.com) as well as two LinkedIn groups relating to microbiology and sterility assurance.

Frank Settineri is the founder and president of Veracorp LLC. He has more than 30 years in the pharmaceutical/biotech industry as a microbiology bench scientist, department head, director of operations and strategic analyst. He spent the first 15 years of his career in the laboratory directing and managing operations. In the following years he built technical and business operations for both a small pharmaceutical company and a testing laboratory, developed a start-up pharmaceutical company and grew the international business of a biotech company. Currently he is dedicated to solving microbial contamination problems, reestablishing GMP compliance, preparing personnel for regulatory audits and identifying operational risks for his clients. He also works with business owners to develop loyal employees. Frank is affiliated to the Parenteral Drug Association, the Society of Industrial Microbiologists and is a speaker for PMF.

Sandra A. Lowery, President of Quality Systems Consulting, Inc., has spent 30 years in injectable pharmaceutical manufacturing, specializing in the areas of contamination control, validation, quality assurance, regulatory affairs, and research and development. Her expertise includes development and validation of aseptic processes, environmental monitoring, process, systems, and equipment validation, specialization in drug GMPs, and extensive interaction with the FDA. Quality Systems Consulting offers pharmaceutically based courses in contamination control, as well as GMP compliance consulting and assessment services. Lowery received her B.A. in science and technology and an M.B.A. from Southern Illinois University, USA. She was a contributing author to the first publication of Microbiology in Pharmaceutical Manufacturing. Lowery is the past and founding president of the Pharmaceutical Technical Exchange Association, which is a joint committee composed of FDA and industry representatives from the Kansas City FDA district.

Maureen J. Mueller has spent over 25 years in the pharmaceutical manufacturing field, specializing in the areas of Quality Assurance, Quality Control, and Regulatory Affairs. During this time, five years were spent in upper management positions, serving as Manager of Quality Assurance. Her expertise includes drug GMPs, aseptic processing, environmental monitoring, microbiological testing, document control systems, stability programs, annual product reviews, validation, and extensive interaction with the FDA. Mueller received her B.S. in Biology from the University of Missouri, St. Louis, USA. She was also a contributing author to PDA Technical Report 35: A Proposed Training Model for the Microbiological Function in the Pharmaceutical Industry, August 2001.

Barry A. Friedman, Ph.D., is a Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing Arena. Dr. Friedman possesses over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, GLP/GMP, quality control, auditing, sterility assurance, microbiological/analytical validations and fermentation technology. He is a frequent seminar and webinar speaker. Prior to becoming an independent consultant, Dr. Friedman was associated with Cambrex Bio Sciences, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, Maryland.
As the Director of Quality Control, he managed a multi-shift department of 31 individuals involved in client management, the receipt and testing of raw materials, environmental monitoring and microbiology, analytical chemistry and QC compliance for the production of Phase 1, 2, 3 and commercial products manufactured from bacteria, yeast and mammalian cells. In this capacity, Dr Friedman enjoyed many client and regulatory interactions, both domestic and international.
In addition to the professional history listed above, other associations have included Chesapeake Biological Laboratories, W.R. Grace, Sigma Chemical Co., Sherwood Medical, Becton Dickinson, American Cyanamid and Union Carbide.
Dr. Friedman received his B.S. degree in Microbiology from The Ohio State University, his M.S. from Michigan State University in Microbial Genetics, and his Ph.D. from The Ohio State University in Microbiology.