Auditing Cleanroom Gown Suppliers

Transcription

1 Microrite, Inc. brings you this unique learning experience in Auditing Cleanroom Gown Suppliers; Part of Microrite s step-by-step webinar series. Auditing Cleanroom Gown Suppliers Understanding product requirements for cleanroom apparel in sterile and non sterile products is crucial to effectively audit gown suppliers. Suppliers of disposable and laundered gowns have requirements and testing that must be met in order to be considered for use in cleanrooms. Learn about the standards, test methods and operational strategies that can be used as audit tools. When? September 5 th, :30pm to 3:30pm Eastern Standard Time Which industries does this conference apply to? Pharmaceuticals, Biotechnology, Medical Device, In Vitro Diagnostics, Food, Beverage, and Pharmacies Who will benefit? Quality Assurance, Quality Control Microbiologists, Facilities, Materials Management, Purchasing, and Training

2 September 5 th, 2013 This 2 hour course will include: Brief overview of reasons behind gowning Common gowning errors IEST-RP-CC003 recommendations Other standards followed by suppliers Sterility assurance for laundered gowns What to look for during the audit Discussion on gowning related FDA 483 observations Who will be teaching? Ziva Abraham, President of Microrite, Inc., a San Jose, CA based consulting and training firm is a well known microbial contamination control expert with over 25 years of academic, research, clinical and industrial experience in Microbiology, and Quality Assurance. Her hands-on experience in varied fields has provided her with the framework to understand the effects of microbial contamination and quality pitfalls from a patient safety perspective. Ziva received her Master s Degree in Microbiology and has conducted graduate work on developing Microbial Insecticides. She has established clinical laboratory systems in Israel, and is involved in expanding Your Horizons, a program through the Math and Science Network to educate young girls about careers in science. She uses her hands on experience in varied fields to teach why assessing risk of microbial contamination should be in the forefront of any company that has products for human/veterinary use or to diagnose disease in humans and/or animals. Microrite, Inc. which was founded in 1998 helps Pharmaceutical, Medical Device, Biotechnology, and In Vitro Diagnostic companies in the areas of microbiological quality control for sterile and non-sterile manufacturing, quality systems procedures, GAP assessment, audits, preparation for inspections, process development, facilities, utilities and equipment validation.

3 REGISTRATION FORM Auditing Cleanroom Gown Suppliers Personal Information of One Registrant Last Name: Mr. Ms. Dr. First Name: Title: Organization: Mailing Address: Telephone: Fee: (see fee structure below) 1 attendee $ attendees $180 (per attendee)(20% Discount) 6-10 attendees $153 (per attendee)(32% Discount) attendees $135 (per attendee)(40% Discount) 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 webinar 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.

4 First and Last Name Additional Attendees

5 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.