Environmental Monitoring Deficiencies

Transcription

1 Microrite, Inc. brings you this unique learning experience in Environmental Monitoring Deficiencies; Part of Microrite s learn from 483 s webinar series. Environmental Monitoring Deficiencies Learn from the mistakes of others. You can t live long enough to make them all yourself. Eleanor Roosevelt Microrite has put this into practice by compiling unique environmental monitoring related FDA 483 observations from Sterile and Non-Sterile Drug Manufacturing and Compounding Pharmacies to cover different deficiencies in establishing and implementing an Environmental Monitoring Program. When? February 4 th, :30pm to 3:30pm Eastern Standard Time Which industries does this webinar apply to? Pharmaceuticals, Biotechnology, Medical Device, Pharmacies, food and In Vitro Diagnostics Who will benefit? Quality Assurance, Quality Control Microbiologists, Facilities, Manufacturing and Training Personnel

2 February 4 th, 2014 Review of over 10 years of environmental monitoring related FDA observations has been used to compile deficiencies in: Site selection Site identification Growth promotion Setting alert and action levels Incubation and reading of results Recording errors Identification of recovered isolates Objectionable microorganisms Data review and assessment of environmental conditions Inadequacy of investigations Who will be 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, 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.

3 REGISTRATION FORM Environmental Monitoring Deficiencies Personal Information of One Registrant Last Name: Mr. Ms. Dr. First Name: Job Title: Organization: Mailing Address: Telephone: Fee: (see fee structure below, all costs are per attendee) 1 attendee $ attendees $180 (per attendee)(20% Discount) 6-10 attendees $153 (per attendee)(32% Discount) 11 or more 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 webinars@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.