Setting up an Environmental Monitoring Program for Pharmacies

Transcription

1 Microrite, Inc. brings you this unique learning experience in Setting up an Environmental Monitoring Program for Pharmacies; Part of Microrite s step-by-step webinar series. Achieving and maintaining sterility and overall freedom from contamination of a CSP is well defined in USP <797>. However there is very little to no guidance on how to set limits, how often to monitor or trend data and recovered microorganisms. Not controlling and monitoring compounding pharmacy environments has grave consequences as seen in current regulatory audits. The standards required for the environmental conditions depend on the amount of exposure of the CSP to the immediate environment anticipated during processing. The quality and control of environmental conditions for each risk level of operation will be discussed in this webinar. When? October 1 st, :30pm to 3:30pm Eastern Standard Time Which industries does this webinar apply to? Pharmacies Who will benefit? Quality Assurance and Pharmacy Personnel

2 October 1 st, 2013 Benefits to participants Learn about environmental monitoring related to: o Aseptically compounded or dispensed preparations o Non sterile preparations Understand why you need to monitor What are the facility claims o Classified o Controlled Do you have enough controls to make these claims How and why to monitor Guidance on setting limits and frequency Monitoring strategy How and why to use the data generated Who will be teaching? Ziva Abraham a known microbial contamination control expert and a seasoned mycologist has educated industry on fungal identification and investigating mold contaminations for over two decades. Her understanding of the origin and behavior of mold makes her a well-respected investigator for mold contaminations. She 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 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. Her experience in clinical laboratories has provided her with the framework to understand the effects of microbial contamination in products from a patient safety perspective. Microrite, Inc. is a consulting company based in San Jose, CA that helps Pharmaceutical, Medical Device, Biotechnology, and In Vitro Diagnostic companies in the areas of microbiological quality control for sterile and non-sterile manufacturing, quality assurance, and validation.

3 REGISTRATION FORM Personal Information of One Registrant Last Name: Mr. Ms. Dr. First Name: Job 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. Webinar cancellation must be received 3 business days prior to the webinar less a 10% service fee, cancellation requests will be accepted via only. All refund requests must be made by the organizations primary contact or credit card holder. Refunds will be credited to the original credit card used to purchase the webinar.

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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.