Not seeing the images? Click Here to view in your browser My Profile      My Products   This Month On IVT Network   Karen Ginsbury gives Validation Straight Talk at Val Week IVT 2015 Speaker of the Year Karen Ginsbury gave a riveting presentation entitled, “Validation and Metrics–Spin or Added Value” at IVT's flagship Validation Week. This video presentation expertly unpacks the complex issues around quantifiable data. Watch the video and view PowerPoint presentation here Instrument Qualification Continues to Generate Questions Despite being a long-standing component of the industry, the validation of lab instruments remains an area of continued debate. Ivan Soto provides thorough and up to date guidance on the sometimes thorny issue in this always timely piece. Read it here IVT Begins 2016 with QMM We're kicking off our 2016 program year with Quality Metrics and Management Week at the Coronado Island Marriott in San Diego. Combining our change control and risk management events, this event provides you with a platform for creating a culture of continuous improvement and innovation. See you there! Download the Brochure. Performing QRM? 5 Important Points Quality risk management is one of the most important components in assuring drug quality and safety, yet companies struggle to conduct effective risk assessments. FDA veteran David Chesney goes over the parts essential to increase your QRM effectiveness in this insider paper. Read all about it here Aging Computer System? No Problem. A perennial problem as first, second, and third generation computer systems begin to show their ages, the so-called legacy computer systems presents its own unique challenges in validation. Laying out guidance and providing real-world examples, this article navigates the complex terrain of these sometimes daunting machines. Read it here PRODUCTS 21st Annual Validation Week Download the all the presentations from IVT's flagship event! Read More Validation Master Plan for US Manufacturer The Validation Master Plan is a valuable opportunity to provide an overview of your company's validation process, including organization structure, content, and planning. Read More HVAC Operation Qualification Protocol This protocol will be executed in compliance as per the requirements in 21CFR 210 & 211 and ICH Q-7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, August 2001. Read More     Recommended for You Write for IVT! Writers are our top assets at the Institute for Validation Technology, and we do everything possible to make sure your writing reaches the most people. Every quarter, the digital pages of JVT and GXP are full of the industry-defining research from the leaders in your field. Whether you are a seasoned professional or just starting your career, we are looking to publish well-crafted pieces from all walks of validation, R&D, compliance, and quality. IVT Multi-User Licenses are Now Available Perfect for companies and universities, this membership allows everyone in your organization to stay up to date on the latest in validation. Make the Most of Your FDA cGMP Inspection Full of critical information for passing FDA inspections, this article demonstrates how an FDA inspection readiness assessment maximizes the probability of passing said inspection. Read it here GXP Talk 71 & 72 IVT's favorite editors are back in their regular segment. Here they tackle validating biological processes and materials deviation. Catch up here Conferences This email was sent by UBM Advanstar | 70 Blanchard Road | Burlington, Ma 01803 Manage Preferences

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