Contamination-Control and Cleaning and Disinfection

Course Description:

This one and a half day course will provide valuable assistance to companies that need to design and implement cleaning disinfection programs in regulated environments.

Contamination occurs in every Cleanroom. Incidents can result in increased Cost of Goods (COGS), plant shutdowns and product withdrawn from the market. The goal is to design and implement an effective cleaning and disinfection program to control your Cleanroom environment in order to minimize risk and successfully troubleshoot excursions once they do occur.

The instructors address the latest industry trends, benchmarked against top Pharmaceutical, Biotech, and Medical Device companies, for establishing, maintaining and working in Cleanrooms that will dramatically reduce microbial excursions and facilitate having successful and accurate root cause investigation outcomes. If your job brings you in contact with any aspect of Cleanroom design, maintenance, environmental monitoring, sampling, testing, sanitization, validation, responses to microbial excursions, root cause investigations, or regulatory interactions, you cannot afford to miss this essential training.

Course Objectives:

• Design and implement and effective cleaning and disinfectant program to control the Cleanroom environment to minimize downtime and get the best product yield.
• Provide guidance on industry trends, regulatory feedback, and designs for a successful disinfection validation program which meet FDA and EMA scrutiny. Current 483's, Warning Letters, and Field Experiences will be conveyed that allow end users to determine that best methods to validate their products against their isolates.
• Microbial control in Oral Solid Dose manufacturing.
• Learn how to develop a successful contamination control program with an emphasis on personnel practices, environmental controls, minimizing risks and avoiding common mistakes.
• Learn how to troubleshoot excursions in Pharmaceutical and Biotech Operations.
• Learn how to start-up a new Cleanroon and re-establish control of a Cleanroom after a shut-downs or worse case events.

Mr. Polarine is a technical service manager at STERIS Corporation. He has been with STERIS Corporation for over eleven years, where his current technical focus is microbial control in cleanrooms and other critical environments

Beth Kroeger

Beth Kroeger, is a Technical Services Specialist for the Life Sciences Division of STERIS Corporation. She currently provides global technical support related to process research cleaners and critical environments.