March 14th, 2014 * San Juan, Puerto Rico Identifying, Preventing, Controlling, Investigating and Remediating Mold Contamination

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1 March 14th, 2014 * San Juan, Puerto Rico Identifying, Preventing, Controlling, Investigating and Remediating Mold Contamination An Intensive & Interactive 1 Day Workshop Mold contaminations are the least understood in the pharmaceutical, medical device industry, healthcare and food related industries. Many do not discover there is an existing mold issue until it has made its presence known in the cleanroom in large quantities or has ended in the product circumventing antimicrobial efficacy. Mold, unlike bacteria, has various methods of propagation and in spore form can remain dormant until conditions are favorable. Understand how not to create favorable conditions for mold to grow. Without understanding mold contaminants, root cause cannot be established and remediation efforts may not be effective. Disinfecting and cleaning practices may seem futile and fogging may not work with major mold contamination events. Link the nature of mold with the efficacy of disinfectants to establish best control remedial practices. This crash course in understanding the various methods of reproduction used by mold, mold identification and the ability of mold to withstand some disinfectants will help mitigate risk and prevent product contamination. Which industries does this workshop apply to? Pharmaceuticals, Biotechnology, Medical Device, and In Vitro Diagnostics, Food, Beverage and Pharmacies Who will benefit? Quality Assurance, QC Microbiologists, Facilities, Manufacturing, Regulatory, Engineering, Training Personnel and Materials Management

2 Overview Understanding the three major groups of mold found in cleanrooms Knowing how variants within each group differ in nature and structure Simple keys to understand the different mold Challenges in identifying fungi Quick tips for identification using macroscopy and microscopy Discussion on automation for mold identification-genotypic and phenotypic Investigating mold contaminations to establish the source Common contaminants in controlled environments that can proliferate if not checked How different groups react to different disinfectants Points to consider when investigating mold contamination Why excessive cleaning and disinfection is not the solution when it comes to cleanroom contamination by mold Understanding how mold can enter the cleanroom Procedures to limit ingress of mold into cleanrooms Assessing risk of mold contamination Fungal infection via mode of administration Clinical relevance of environmental and product mold contamination Other unseen challenges Common remediation strategies Overview of different disinfectants used in the industry Understanding the fungicidal claim of these disinfectants Why disinfectant qualification studies fail with certain mold Fogging and VHP an option during contamination Points to consider when fogging

3 Agenda (March 14 th, 2014) Registration and Breakfast VENUE AND WORKSHOP AGENDA Caribe Hilton 1 San Geronimo street March 14 th 2014 San Juan, PR Telephone : +1(787) PROGRAM Understanding the three major groups of mold found in cleanrooms Break Investigating mold contaminations to establish the source Lunch Assessing risk of mold contamination Break Common remediation strategies Questions and Answers 8.00 AM to 8.30 AM 8.30 AM to AM AM to AM AM to PM PM to 1.00 PM 1.00 PM to 3.00 PM 3.00 PM to 3.15 PM 3.15 PM to 4.15 PM 4.15 PM to 5.00 PM The Caribe Hilton, located in San Juan, Puerto Rico, is one of the best-known hotels in the Caribbean. It was the first facility ever operated by Hilton Hotels outside of the continental United States Admire ocean and tropical garden views from Caribe Hilton hotel. Set on a secluded peninsula and boasting 17 acres of lush foliage, the resort is ideally situated between Old San Juan and contemporary Condado

4 REGISTRATION FORM Personal Information of One Registrant Last Name: Mr. Ms. Dr. First Name: Job Title: Organization: Mailing Address: Telephone: Fee: $ per attendee (Includes 1 day workshop fee, breakfast, lunch, break, 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 workshop date. If you have any questions regarding payment methods feel free to contact Microrite at or send your enquiry to labraham@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. Workshop cancellation must be received 10 business days prior to the workshop less a 10% service fee, cancellation requests will be accepted via only. The organizations primary contact or credit card holder must make all refund requests. Refunds will be credited to the original credit card used to purchase the workshop..

5 PAYMENT INFOMATION 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/State: Zip Code: Country: Contact Ph No & Card Number: Expiration(Month/Year): 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..

6 Our presenters are experts in the field of disinfectants and disinfect qualification and passionate about teaching! Ziva Abraham, a known microbial contamination control expert and a trained mycologist has educated industry on fungal identification for over a decade. Her understanding of the origin and behavior of mold makes her a well respected investigator for mold contaminations. Ziva 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 during her graduate studies working mainly with fungi. She has established clinical laboratory systems in Israel, and Microrite, Inc. a consulting company based in San Jose, CA that helps Pharmaceutical, Medical Device, In-vitro Diagnostics and Biotechnology Companies. Microrite focuses on helping companies with contamination control, microbiological quality control for sterile and nonsterile manufacturing, quality assurance, and validation. She is a mentor for graduate students..