Disinfectant Qualification Bacteria, Fungi, Viruses and Atypical Organisms A Step by Step Workshop

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1 Microrite, Inc. brings you this unique advanced course in ; part of Microrite s Step by Step Workshop Series Participate in the only workshop which will guide you through the process of choosing a cost effective and compliant disinfectant qualification method, which suites your company budget, personnel availability, urgency and time limit Also learn how to plan study execution schedule and supplies, how to budget costs, and how to execute each step and assess errors that may occur This workshop will also cover data analysis, establishing expiry dates for diluted and undiluted disinfectants and how to apply the findings to the cleaning procedures Do not miss this opportunity if planning a disinfectant qualification study or have performed one and wish to verify it Learn from the case studies presented at this workshop. Additionally learn about using viruses and atypical microorganisms. Understand the methods used for the organism cultivation as well as technicalities associated with eliminating false positive results during disinfectant qualification studies using viruses. Which industries does this seminar apply to? Industries that will benefit from this training are Pharmaceuticals, Biotechnology, Medical Device, and In Vitro Diagnostics Who will benefit? Microbiologists performing, and reviewing Studies, Quality Assurance, Regulatory and Manufacturing personnel

2 DAY 1 Disinfectants commonly used in the industry, their modes of action, efficacy, and toxicity Understanding the nature of contaminants in the cleanroom and which disinfectants will be effective against them Overview of the many methods and variations used for disinfectant qualifications o Tube dilution method Using filtration Using neutralizing broth o Representative Hard Surfaces Using contact plates Using Swab Recovery Method Using Rinse Method Using Neutralizing Broth Using Sonication Discussions on the variants of each of the methods and the benefits and shortcomings of each method Discussion on the pitfalls expected when choosing each method available Protocol o Guidance on drafting a Disinfectant Study Protocol for each of the methods discussed Planning the Study-Scheduling and Costs o Using planning templates, guidance will be provided for breaking up the study components to manage scheduling, costing and ordering supplies to avoid waste due to expiry of media and buffers Managing personnel o Planning each section of protocol for execution o Planning of daily activities while maximizing testing Method Validation for Bacteria and Fungi o How to validate each method o What to look for as acceptance criteria Recovery Study o Guidance on how to perform swabbing studies to get maximum recovery o How to plan a recovery study for various methods of efficacy testing o Understand the facts and myths about recoveries Bonus Session: Wet disinfection vs. dry decontamination Dry decontamination of manufacturing facilities Wet disinfection vs. dry decontamination Overview of fogging technologies Case studies of dry decontamination of food producing plants

3 DAY 2 Efficacy Testing o Points to consider when planning an efficacy study o How to mitigate inoculum count drop o Application of inoculum and disinfectants-what to pay attention to o Log reduction calculation Time 0 Verification o Understand why this additional step gives more confidence in the data generated from the efficacy study Expiry Dating Study for Disinfectants o How to review efficacy data to abbreviate expiry study which will generate dependable results for assigning expiry date for pre-diluted disinfectants and concentrated disinfectants that do not have an expiry assigned by the manufacturer Log Reduction Calculation o Data analysis o Common errors o Detecting false positive or false negative log values Reviewing Data o How to identify execution errors when reviewing data. Establish and Implement corrective actions Overview of testing disinfectants using biofilms Translation of disinfectant qualification results to cleaning procedures to prevent contamination o Cleaning procedures-what should be addressed o How to monitor efficacy of the cleaning program Commonly observed deficiencies in studies that may lead to contamination or FDA observations Sanitization Studies/ using Viruses and Atypical Microorganisms Growing viruses-points to consider o Eliminating False Positives during the sanitization studies o Pre-requisite testing to be performed for the viruses and cell lines (used for the viral cultivation) prior to the initiation of the viral sanitization studies. o Recovery Testing and Sanitization Study Qualification Testing o Challenges for defining the appropriate dilution of neutralizer that will not affect the cells or viruses o Choice of Testing Method to be used for the virus sanitization study testing. Growing Atypical Bacteria-points to consider. Defining the testing sequence and methodology to be used for the study. Testing process and modification of some parameters for a successful recovery testing. Use of a different medium for bacterial cultivation. Length of incubation. Process of bacterial elution from spiked substrates (sonication versus scraping or vortexing etc) Protocol Points to consider

4 VENUE AND CONFERENCE AGENDA September 13 th & 14 th,2012 MIT ENDICOTT HOUSE 80 Haven Street Dedham, MA PROGRAM Day 1 (September 13 th, 2012) Registration and Breakfast 8.00 AM to 8.30 AM Overview of Disinfectants 8.30 AM to AM Break AM to AM Overview of Methods AM to AM Lunch PM to 1.00 PM Planning the Study and Study Details 1.00 PM to 3.00 PM Break 3.00 PM to 3.15 PM Wet disinfection vs. dry decontamination 3.15 PM to 4.15 PM Questions and Answers 4.15 PM to 5.00 PM Day 2 (September 14 th, 2012) Breakfast 8.00 AM to 8.30 AM Efficacy Testing Details for Planktonic and Biofilm 8.30 AM to AM Microorganisms Break AM to AM Data Review and 483 Observations AM to PM Questions and Answers 11.45AM to PM Lunch PM to 1.00 PM using Viruses and Atypical Organisms 1.00 PM to 3.00 PM Coffee Break 3.00 PM to 3.15 PM Challenges in growing Viruses and Atypical Organisms 3.00 PM to 4.00 PM Protocol Considerations 3.45 PM to 4.15 PM Questions and Answers 4.15 PM to 5.00 PM Endicott House is not your ordinary Endicott House is not your ordinary conference center in Boston. Built in 1934 and surrounded by numerous acres of magnificent gardens, Endicott House mansion's French manor style defines the merging of historic refinement and modern amenities. The estate is located in a secluded setting on 25 acres. The sleeping rooms in this mansion are one of a kind with antique décor. They offer fine food, and exceptional service. This unique conference center venue is minutes from Boston.

5 REGISTRATION FORM Personal Information of One Registrant Last Name: Mr. Ms. Dr. First Name: Title: Organization: Mailing Address: Telephone: Fee: $ per attendee (Includes 2 day seminar fee, breakfast, lunch, break for all days, and course material) Additional Attendees Method of Payment: Credit Card and Check payments only. Attendees can register and make payments on Microrite s website- or complete this form and fax to Check payments must be cleared before the seminar date. If you have any questions regarding payment methods feel free to contact Microrite at or send your enquiry to info@microrite.com. Confirmation of registration will be sent via . For credit card payment on website, a payment receipt will be considered as confirmation of registration. For credit card information faxed to Microrite an confirmation will be sent with a copy of payment receipt. Please call in due time if confirmation is not received after payment. Hotel Accommodation **Only 10 mansion rooms available! MIT Endicott House 80 Haven Street, Dedham, MA Phone: or

6 PAYMENT INFORMATION Choose One (Place X) VISA Master Card American Express Card Holder s Name Address of Card Holder: Enter firm address for corporate card or personal address for personal card Street: City: Zip Code: Country: Contact Ph No & Card Number: Expiration(Month/Year): Name on Card: Amount (US Dollars): Signature: Name of Attendee(s) Referred by: Kindly note the name of the company or person that referred you to this workshop. We would like to thank them..

7 Our presenters are experts in their fields and passionate about teaching! Jon Ruppert is Eastern Regional Manager for Mar Cor Purification. Prior to Mar Cor Purification Jon worked 8 years with Siemens Water Technologies in the Pharmaceutical High Purity Process Water Business running their BioPharm Market Team as well handling Strategic Accounts. Prior to Siemens Water Jon worked for 10 years for STERIS Corporation in their Life Sciences and Healthcare Businesses with experiences in Marketing, Strategic Planning and Research and Development. Jon s thirty plus years of experience includes water purification, hard surface disinfection, vapor and dry fog disinfection, steam sterilization and multiple effect distillation and pure steam generation. Ziva Abraham has over 25 years of academic, research, clinical and industrial experience in Microbiology, and Quality Assurance. She has trained personnel from various industries in microbiology techniques and methods. Ziva has received her Master s Degree in Microbiology and has conducted research on developing Microbial Insecticides. She has established clinical laboratory systems in Israel, Microrite, Inc. a consulting company based in San Jose, CA and Microrite Training Center in Santa Clara, CA. Microrite helps Pharmaceutical, Medical Device, Biotechnology and Combination Product Companies, and In-Vitro Diagnostics in the areas of Quality Assurance, Validation, Process Development and Microbiological Quality Control. She is a known microbial contamination control expert who is teaching disinfectant qualification internationally using her hands on experience in performing numerous disinfectant qualification studies and reviewing study data to assess validity and applicability of the data for establishing cleaning programs. Ziva also is a known mycologist teaching hands on fungal identification and investigating mold contaminations in facility, process and product. Charity Ogunsanya is the Director of Quality Control at Aeras (Tuberculosis Vaccine Research and Development Company) with overall responsibility for the Quality Control testing Laboratory. She has over 21+ years of extensive experience not limited to Aseptic Processing, Contamination Control, Quality Control, Microbiology, Sterility Assurance, Quality Assurance, Vaccine Development, Product Design, Testing and Validation. She is also vast in both national and international regulatory bodies requirements such as the FDA, EMEA, EU, TGA, JP, ISO etc. She has extensive industry experiences within the Biologics, Pharmaceuticals, Radiopharmaceuticals, Biotechnology and Medical Device Industries. Charity also consults for the Gerson Lehrman Group (GLG), Intota Expert Network, and Zintro Expert Network which are all high level international professional expert network consulting corporations targeted towards investment banking operations and other corporations..