Seminar Basic Concepts in Cleaning and Cleaning Validation for GMP Regulated Industries

Thursday, September 20, 2012

Date and Location:
Thursday, September 20, 2012
Four Points Sheraton – Mississauga
2501 Argentia Road
Mississauga, ON, Canada
905-858-2424

To register please contact:
Linda Peterson at 314-290-4743 or linda_peterson@steris.com
Conference fee: 100 USD payable by check or credit card

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.

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:
Quality Assurance
Regulatory
Plant Manager
Quality Control
Operations
Compliance Officer
Microbiology
Engineering
R and D

Presenters:

George Verghese is director of technical services in the Life Sciences Division of STERIS Corporation. 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.

Paul Lopolito is a technical services manager for the Life Sciences Division of STERIS Corporation. He currently manages the PACE program and provides global technical support related to process cleaning and contamination control, which includes field support, site audits, training presentations and educational seminars. Paul has over 15 years of industry experience and has held positions as a technical services manager, manufacturing manager and laboratory manager. Paul is a frequent speaker at industry events including the PDA, ISPE, INTERPHEX, ACHEMA, AALAS, and IVT. Paul has published several articles and book-chapters related to cleaning and cleaning validation. He earned a B.A. in Biological Sciences from Goucher College in Towson, MD.

Agenda

7:30 – 8:-30 Registration
1:00 – 2:00 Lunch provided
9:00 – 5:00 Program

Topics
Introduction to Cleaning Validation

Cleaning Process Design and Development
-Cleaning Chemistries and Methods
-Laboratory Studies, Design Space & Scale Up
-Case Studies

Residues and Limits
-MACO Calculations & Risk-MaPP
-Cleaning Agent Residues
-Special Cases

Sampling and Analysis
-Rinse and Swab Sampling
-Method Validation Principles
-Recovery Studies

Cleaning Qualification
-Risk Based Approach
-Grouping Strategies
-Dedicated Equipment, Campaigns

Continued Process Verification
-Preventive Maintenance,
-Derouging, Passivation
-Bioburden and Biofilms

Regulatory Issues
-Regulations and guidances

4:30 – 5:00 Q&A and Adjourn

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