Basic Concepts in Cleaning and Cleaning Validation for GMP Regulated Industries
Why Attend this Seminar?
STERIS Corporation (www.STERISLifeSciences.com) is the industry leader in providing cleaning, cleaning validation and microbial control solutions to the pharmaceutical manufacturing industry. For over 20 years our team of experts has provided non-commercial seminars and presentations based on both current Good Manufacturing Practices and on real-world experience in addressing the cleaning, cleaning validation and microbial control challenges of regulated industries. This seminar will provide industry examples and real-world insights into development of robust cleaning programs, and will provide both a review of relevant regulatory guidance as well as practical information on validation of robust cleaning programs. The focus of this seminar will be processing equipment cleaning and cleaning validation.
Seminar to be delivered in English with simultaneous Portuguese translation
Who Should Attend?
This seminar is designed for professionals in pharmaceutical manufacturing who are responsible for high-quality, efficient, cost-effective, and compliant production results:
Operations Compliance Officer
Date and Location:
Tuesday, June 12th, 2012
Mercure Sao Paulo Vila Olimpia Rua Santa Justina, 210
SAO PAULO - SP
04545041 - SAO PAULO
Phone : (55)11/3089 6222
Fax :(55)11/3089 6243
Thursday, June 14th, 2012
Naoum Express Anapolis
BR 153, 3.661 – St. Ind. Aeroporto
CEP: 75.113 – 971 Anapolis – GO
Phone: (62) 3099 5000
Fax: (62) 3099 9500
To register please contact:
George Verghese is director of technical services in the Life Sciences Division of STERIS Corporation. He directs the technical services group for formulated chemistries and oversees the Process and Cleaner Evaluation (PACE) Laboratory. Mr. Verghese has worked in the areas of manufacturing, product and applications development, and technical services for more than 25 years. Prior to STERIS, he held engineering positions at Bristol-Myers Squibb and Calgon Vestal, a subsidiary of Merck & Co. Mr. Verghese has written numerous articles and book chapters on topics related to contamination control. He is a member of the editorial advisory board of the Journal of Validation Technology and the Journal of GxP Compliance. As a speaker at industry conferences, he has lectured to pharmaceutical industry audiences worldwide on various aspects of process equipment design and cleaning validation. He holds a master’s degree in chemical engineering and is an active member of the ISPE, PDA, and ASTM.
Destin LeBlanc consults in the area of cleaning validation as the owner and principal consultant of Cleaning Validation Technologies. Previously, he had been with STERIS/Calgon Vestal for over twenty years, primarily in product development and technical service for cleaning and antimicrobial applications. He has lectured on issues related to contamination control internationally, and has written widely on cleaning validation issues. He is the author of three books: Validated Cleaning Technologies for Pharmaceutical Manufacturing; Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing- Volume 1; and Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing- Volume 2. He maintains the web site www.cleaningvalidation.com as a resource for cleaning validation professionals. He is a member of PDA and ISPE, is on the faculty of the PDA Training and Research Institute, and regularly trains FDA personnel on cleaning validation. He is a graduate of the University of Michigan and the University of Iowa.
Elizabeth Rivera is a technical service specialist for the Life Sciences Division of STERIS Corporation (Mentor, Ohio). Currently, she provides technical support in the areas of formulated detergents, disinfectants for critical environments, and sterility assurance products. In addition, she specializes in cleaning validation processes and lectures at technical educational forums, such as IPA, Interphex, ExpoFYBI, IVT, and Executive Conferences. Elizabeth has 10 years of industry experience and she has held positions in pharmaceutical manufacturing companies. She has published articles related to cleaning and cleaning validation. She earned a Bachelor and Graduate degree in Chemical Engineering from the University of Puerto Rico.