| Seminars and Targeted Training Programs
STERIS Life Sciences Technical Services offers the
following two different on-site seminars for Life Sciences
customers.
#1CLEANING AND
CLEANING VALIDATION
#2 MICROBIAL CONTROL IN PHARMACEUTICAL
AND MEDICAL DEVICE CLEANROOMS
TARGETED TRAINING PROGRAMS
CLEANING AND
CLEANING VALIDATION
Cleaning and Cleaning Validation is a two-day seminar for
pharmaceutical manufacturers addressing the practical
aspects of meeting FDA cleaning requirements. The class
focuses on cleaning and cleaning validation of product
contact surfaces in process manufacturing; please note
that it does not cover general environmental cleaning
in cleanrooms.
TOPICS COVERED:
- Cleaning Objectives
- Validation Programs
- FDA Expectations
- Cleaning Technologies
- Process and Engineering Issues
- Cycle Development
- Residues and Limits for Cleaning Agents
- Microbial Issues in Process Manufacturing
- Issues in Non-Routine Cleaning
- Analysis and Sampling
- Cleaning SOPs
- Validation Protocols
- Monitoring Issues
- Trouble Shooting Cleaning Problems
FEE:$ 5,000 USD plus Travel Expenses for Speakers (includes seminar and seminar notes for up to 50 attendees.
TO INQUIRE ABOUT SCHEDULING A SEMINAR AT YOUR SITE: Call 1-314 290-4743 or contact your STERIS account manager
PRESENTERS: The presenters for this seminar are Destin LeBlanc, Principal Partner, Cleaning Validation Technologies LLC, San Antonio, Texas., and George Verghese, Manager of Life Science Technical Services in St. Louis, Missouri.
MICROBIAL CONTROL IN PHARMACEUTICAL
AND MEDICAL DEVICE CLEANROOMS
This one-day microbial control seminar provides regulatory based and industry -standard practice based information to pharmaceutical and medical device manufacturers on the proper sanitization of cleanrooms and other critical environments. The information covered in this seminar includes disinfectant mechanisms of action, selection criteria, application and validation. This seminar grew out of several on-site seminars that were held at the request of pharmaceutical and medical device facilities that were seeking guidance in establishing microbial control programs.
TOPICS COVERED:
- Microbial Control Technologies - Disinfectant Chemistry, Disinfectant Regulation, and Quality Control Aspects
- Selection and Integration of Chemistry and Application Options
- Validation Practices and Troubleshooting Techniques
- Substrate Compatibility
- Chemical Residue Testing
- Isolator Sanitation Issues
- Personnel Issues
- Troubleshooting Microbial Excursions
FEE: $ 2,500 USD plus Travel Expenses for Speakers (includes seminar and seminar notes for up to 50 attendees.
TO INQUIRE ABOUT SCHEDULING A SEMINAR AT YOUR SITE: Call 1-314 290-4743 or contact your STERIS account manager
PRESENTERS: The Presenters for this seminar are Elaine Kopis Sartain, Director of the Life Science Technical Services Group and Jim Polarine, Technical Services Specialist, both located at the STERIS St. Louis location. Elaine and Jim are responsible for providing assistance to STERIS customers in selection and application of disinfectants and cleaners and for providing educational seminars and literature to customer groups.
TARGETED TRAINING PROGRAMS:
In addition to the above on-site seminars, the STERIS Life Sciences Technical Services team can also create and deliver targeted training programs, typically in the one to two hour time frame regarding the following process cleaning and cleanroom oriented topics:
Selection and Application of Aqueous Cleaners
Cleaning Process and Engineering Issues
Cleaning Validation Requirements
Residues and Limits for Cleaning Agents
Disinfectant Selection and Application
Disinfectant Validation
Troubleshooting Microbial Excursions
Establishing Microbial Limits
Personnel Issues in Cleanroom Management
Please contact the STERIS Life Sciences Technical Services Team for more information regarding our targeted training programs. We can be reached at 1-314-290-4743.
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