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How to Use Hydrogen Peroxide Biocides in Cleanrooms

How to Use Hydrogen Peroxide Biocides in Cleanrooms

Webinar series for 2015-No. 1

（Synchronous subtitle translation will be provided）

Organizer：NovoScience Consulting

Date：March 30, 2015

------------------------------------------- Our Instructor --------------------------------------------

Jim Polarine

Mr. Polarine is a technical service manager at STERIS Corporation, who has been with STERIS Corporation for over fourteen years. His current technical focus is microbial control in cleanrooms and other critical environments. He has lectured in North America, Europe, Asia, and Latin America on issues related to cleaning and disinfection in cleanrooms. Mr. Polarine is a frequent industry speaker and published several PDA book chapters and articles related to cleaning and disinfection and contamination control. He frequently presents global industry webinars on Cleaning and Disinfection for several industry seminar circuits including Compliance Online, Global Compliance Panel, and Executive Conferences.

1. WEBINAR OVERVIEW

Liquid and vapor hydrogen peroxide is an ideal disinfectant for class A,B and C cleanrooms a three-log reduction of bacteria and spores (ozone is unable to achieve this effect). However, hydrogen peroxide is a powerful corrosive and oxidizing agent, which may cause damage to piping, equipment, ceiling, metope and floor made by reactive materials. It is critical to understand the proper implementation and validation methods of hydrogen peroxide to ensure the safety and the disinfection effect. Mr. Jim Polarine， the senior technical expert from the preeminent disinfectant company STERIS， is invited by NovoScience Consulting to introduce how to use hydrogen peroxide correctly in cleanrooms.

The following topics will be covered：（1）cleaning and Disinfection of cleanroom operations with Hydrogen Peroxide and Vaporized Hydrogen peroxide (VHP). Routine cleaning and disinfection, the latest equipment, application methods, and frequencies of application will be introduced to developing a long term sustainable cleaning and disinfection program that proactively addresses cleaning challenges and bioburden challenges;（2）rotation of disinfectants, resistance, application methods and disinfectant validation as it relates to hydrogen peroxide biocides;（3）Contamination control of fungal and bacterial spores during cleaning and disinfection;（4）FDA Recent 483s and Warning Letters related to cleaning and disinfection, especially for disinfectant rotation as the current trends in residue control and remediation.

1. WEBINAR COURSES

Date	Instructor	Training contents
Friday, March 30, 2015 9:00-11:00	Jim Polarine	l Designing an Effective Cleaning and Disinfection Program l Contamination Control l Validation of Disinfectants l Gaining and Re-establishing Control of Your Cleanroom l Aseptic Processing and Contamination Control l Current regulatory trends in the industry l Troubleshooting Microbial Excursions
11:00-11:30		l Questions and Answers
Next Webinar （Webinar series for 2015-No. 2）
Applied Statistics for QA, QC, Manufacturing, and Design Control o Why should you attend: Almost all design and/or manufacturing companies evaluate product and processes either to establish product/process specifications, to QC to such specifications, and/or to monitor compliance to such specifications. The various statistical methods used to support such activities can be intimidating to master. If used incorrectly, such methods can result in new products being launched that should have been kept in R&D; or, conversely, deciding to not launch a new product because of incorrectly calculated product reliability or process capability. In QC, mistakenly chosen sample sizes and inappropriate statistical methods may result product being rejected that should have passed, and vice-versa. o Who Will Benefit: QA/QC Supervisor; Process Engineer; Manufacturing Engineer; QC/QC Technician; Manufacturing Technician; R&D Engineer
Introduction of NovoScience Consulting and Subsidiaries.
o NovoScience Consulting （Hong Kong）: NovoScience Consulting is a well-known consulting company specialized in US/EU/WHO/China GMP-compliance. The business scope includes API/Generic submissions (covering response plans, mock audit, deficiencies correction, accompanying audit etc.), US/EU GMP gap audit and system improvement, third party supplier audit, the establishment and improvement of six modern GMP systems, facility qualification and validation, faxility design GMP review etc. Contact: Mr. Jack Zhang, Tel: 136 3633 6667, Email: jack@shnovoscience.com o Alban Pharma (Hong Kong) Co., Ltd: As a member of NovoScience consulting Complex, Alban Pharma is a professional consulting service company for pharmaceutical manufacturing. The business scope includes overseas contract manufacturing, US/EU MA operation, EU MA Licensing and transfer for Chinese pharmaceutical products, and API/Generics international marketing. Contact: Mr. Ross Xiao, Tel: 138 1770 1197, Email: ross@albanpharma.com o Patterson Pharma Design & Consulting: PPDC is a pharmaceutical engineering design organization under NovoScience Consulting, focusing on conceptual design. The business scope include manufacturing facility conceptual design for high potency drugs (e.g. antineoplastic drugs), high-toxic drugs (e.g. drugs with OEB>3 ), highly sensitizing drugs (e.g. Beta-lactam antibiotics). Contact: Mr. Jack Zhang, Tel: 136 3633 6667, Email: jack@shnovoscience.com

1. REGISTRATION

n Notes

How to Use Hydrogen Peroxide Biocides in Cleanrooms

Webinar series for 2015-No. 1

March 27，2015

Attendance Fee

Trainees would be able to watching the on-site training lectures and discussion through NovoScience training website （www.shnovoscience.com）, and will be able to interact with instructors though GOTOMEETING platform (click here to download GOTOMEETING platform). Each company shall register one account only. The registration fee would the following:

1. US$800/company for companies who had participated in our previous trainings.

2. US$1000/company for companies who has never participated in our trainings.

² Click here for the new webinar experience

² Registration fee includes training material (electronic-version), contact list, training certificate, etc.