Microbial Contamination Testing and Validation Challenges Non-Sterile Products and Raw Materials

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1 Microrite, Inc. brings you this unique learning experience in Microbial Contamination Testing and Validation ; Part of Microrite s step-by-step webinar series. Microbial Contamination Testing and Validation Challenges With the growth of the pharmaceutical industry at around 5 to 8 percent per annum the industry has seen a subsequent increase in failures in microbial contamination tests. Now more than ever it is important for microbiologists to understand the testing requirements, methods, and validations. A microbial contamination test is one of the most common and mandatory tests in all pharmaceutical non-sterile products such as tablets, liquids and other oral, nasal, topical products, and raw materials. An understanding of the microbial contamination test and of microbial recovery validation will equip the microbiologist with tools to conduct an effective risk assessment. This knowledge will also allow them to improvise and gain insights into the trouble shooting required in case of OOS and OOT results, and enhance the knowledge on the factors that affect the output of microbial contamination results. When? February 19 th, :00am to 1:00pm Eastern Standard Time Which industries does this webinar apply to? Pharmaceuticals, Biotechnology, Cosmetics, Dietary and Nutritional Supplements, and In Vitro Diagnostics Who will benefit? Quality Assurance, Quality Control, Microbiology, Manufacturing, Validation, Materials Management, and Training Personnel

2 February 19 th, 2015 Benefits to the participants: Understanding the challenges in microbial contamination testing Discussion on sample amounts needed Pretreatment of samples - why and when it is required How to choose neutralizing agents Test procedure as per Harmonized Compendial Methods Importance of media in microbial contamination testing Microbial recovery validation - a critical parameter Handling out of specification results Who will be teaching? Nilesh Shinde, Technical Director of Microremediz- Expert Microbiology Solutions has over 15 years of experience in the pharmaceutical industry. He has served as an advisory panel member for Antibiotic Chapter ( ) at monograph development of US Pharmacopoeia. He has been in-charge of microbiology method development lab at Cipla. He has also worked with India Council of Medical research - Enterovirus research Centre on National Polio Surviellance project. He has also worked and evaluated various identification systems such ATP Bioluminescence, Milliflex, and Chemscan RDI to name a few.

3 REGISTRATION FORM Microbial Contamination Testing and Validation Challenges 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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