Cleaning Validation-Common Errors

Transcription

1 Microrite, Inc. brings you this unique learning experience in Common Errors in Cleaning Validation; Part of Microrite s step-by-step webinar series. Cleaning Validation-Common Errors Drug products are capable of being contaminated in myriad ways. Contamination may occur via filling components (tips, caps, bottles, or stoppers); when coming in contact with processing equipment (tanks, manifolds, fillers, machine-syringes, pistons, and blocks); the manufacturing environment, or manufacturing operators. Some equipment may require cleaning revalidation if components come in direct contact with the product, others may not. A cleaning validation master plan, well thought through and established with a scientific rationale behind it, is the first step in the right direction. Depending upon the phase of product, type of product and the risk of contamination or cross contamination, cleaning validation program can be adjusted, yet ensuring safety of product and patient. When? October 16 th, :30pm to 3:30pm Eastern Standard Time Which industries does this conference apply to? Industries that will benefit from this training are: Pharmaceuticals, Biotechnology, Medical Device, and In Vitro Diagnostics Who will benefit? Quality Assurance, Quality Control Microbiologists, Manufacturing, Validation, Engineering, and Training

2 16 October, 2012 Benefits to the participants: Critical components of a Cleaning Program and Cleaning Validation Master Plan Determining a strategy for your cleaning program Understanding the impact of raw materials, intermediates, and API s on a strategy Structuring your CVMP for ease of maintenance Developing Standard Operating Procedures (SOPs) for Cleaning Processes How to choose the cleaning validation method Overview of the common methods used benefits and pitfalls Supporting Studies Validating recovery-a critical component of method validation Components of the Cleaning Validation protocol FDA 483 observations related to cleaning validation Who will be teaching? Keith Bader A recipient of Bachelor s degree in Chemical Engineering from University of Colorado at Boulder, Keith has been with Hyde Engineering + Consulting, Inc. since 1999 and worked in a variety of areas, from control systems to validation cleaning science. He provides high level consultation to Hyde Engineering's clients in topic areas ranging from strategic quality and validation system architecture and documentation to detail oriented support such as design of experiments for supporting studies. More recently, he has focused on the implementation of online instrumentation and process analytical technologies, (PAT) for clean-in-place systems, as well as the translation of bench scale cleaning process development data to full scale manufacturing systems. Keith s expertise in cleaning science has resulted in current contributions to publications in Pharmaceutical Engineering and to a chapter in PAT Applied in Biopharmaceutical Process Development and Manufacturing: An Enabling Tool for Quality-by-Design by Duncan Lowe. Keith is a member of the International Society for Pharmaceutical Engineering (ISPE), American Institute of Chemical Engineers (AIChE), and the Parenteral Drug Association (PDA).

3 REGISTRATION FORM Cleaning Validation-Common Errors 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.

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