Pharmaceutical and Research Seminars

STERIS Pharmaceutical and Research Technical Services offers the following two different on-site seminars for Pharmaceutical and Research customers.
Cleaning and Cleaning Validation | 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 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 Pharmaceutical and Research 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 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 Pharmaceutical and Research Technical Services Team for more information regarding our targeted training programs. We can be reached at 314.290.4743.