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

Thursday, October 11, 2012

Date and Location:
Thursday, October 11th 2012 
Guadalajara
México
Holiday Inn Select
Av. Niños Héroes: 3089 M1-A Esg. López Mateos, Col. Jardines de los Arcos
Guadalajara, Jalisco, México. C.P. 44500
Tels: 3122-2020 y 3122-7575

To register please contact:
JULIO GAMAS
CYTNIS
5824-4921
jcgamas@cytnis.com.mx


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 Spanish 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:
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. 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.



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
-Cleaning & Process Equipment Engineering Issues
- Laboratory Studies & Scale Up

Residues and Limits
-MACO Calculations & Risk-MaPP
-Cleaning Agent Residues
-Bioburden, Endotoxin, and Microbial Limits

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

Cleaning Qualification
-Protocols and Protocol Challenges
-Grouping Strategies
-Dedicated Equipment Campaigns

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

Regulatory Issues
-Global Regulations: US GMP, EU GMP, ICH
-Guidance Documents: FDA, PIC/S, WHO, Other

Q&A and Adjourn

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