MICROBIAL LIMIT TESTS FOR RAW MATERIALS AND NON-STERILE PRODUCTS REVIEW-DISCUSSIONS-INTERPRETATIONS

Transcription

1 Microrite, Inc. brings you this unique learning experience in microbial limit tests for raw materials and non-sterile products-review-discussions-interpretations Part of Microrite s step-by-step webinar series. Microbial Limit Testing is performed on raw materials and non-sterile products to ensure that the material or product complies with compendia specifications for microbial quality. The testing is two part; one to estimate the total count of aerobic microorganisms and total number of yeast and mold and the second part is designed is determine the presence or absence of specific objectionable organisms in the product. Inadequate testing due to misconception could result in testing for objectionables or validating using organisms that may not be objectionable to the product. When? May 29th, :30pm to 3:30pm Eastern Standard Time Which industries does this conference apply to? Industries that will benefit from this training are: Pharmaceuticals, Biotechnology, and In Vitro Diagnostics Who will benefit? Quality Control Microbiologists, Quality Assurance, Training and Regulatory Personnel

2 This 2 hour course will include: 29 May, 2012 Regulatory Significance of Microbial Limit Tests in the US Pharmacopeia International Harmonization of Microbial Limit Tests Critical Factors in Microbial Limit Tests Microbial Examination of Non-sterile Products- Enumeration Tests <61> Microbial Examination of Non-sterile Products- Tests for Specified Microorganisms <62> Microbial Examination of Non-sterile Products- Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use<1111> Risk Management of Microbial Limit Tests of Non-sterile Products Who will be teaching? Dr. Roger Dabbah; Principal Consultant for Tri-Intersect Solutions that he founded in April 2006 was Senior Scientific Fellow in the Department of Drug Standard Development, US Pharmacopeia. He tracked new technologies such as nanotechnology and all the omics technologies (genomics, proteomics, metabolomics, bioinformatics, genetic testing, and stem cells research) to position USP standards in the future. He was the USP representative to AAMI, ANSI, IEST, PDA, BIO and worked in a number of US-Technical Advisory Groups involved in ISO Technical Committees. He was also the US representative to the WHO Biological Standardization Committee in Geneva. Dr. Roger Dabbah was Director, Complex Actives Division in the Information and Standards Division of USP which he joined in 1986.At USP his responsibilities included management of liaisons with the USP Council of Experts, Industry, Government and Academia in the various areas of biologicals, biotechnology, gene therapy, tissue engineering, microbiology, devices and diagnostics, toxicity testing, biocompatibility, alternatives to animal testing, international harmonization in biotechnology and microbiology, parenterals, radiopharmaceuticals, Pharmaceutical Waters. Dr. Dabbah is active in civic activities. He was a Commissioner on the Humanities for Montgomery County and now is a Board member of the Friends of the Humanities Commission. He is also a Director on the Board of the PDA Foundation for Pharmaceutical Sciences and was the Chair of the fund-raising Committee and now is the chair of the Communication Committee.He is also on the editorial board of a number of publication, including Pharmaceutical Technology, Bioprocess International, and others.

3 REGISTRATION FORM 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 Additional Attendees First and Last Name

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: 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.