Decoding CLIA (Clinical Laboratory Improvement Amendments) Regulations: Calibration, Calibration Verification and Method Validation
The Clinical Laboratory Improvement Amendments (CLIA) training will outline the CLIA standards for frequency, methodology and also give examples of practical application.
Traceability and Recall in Food Processing
This webinar will cover traceability requirements and techniques useful in the event of quality deviation investigations and potential FDA Recalls. The session will also cover associated information like identification, classification and protocols.
Sage Bionetworks Announces Program to Develop BRIDGE: An IT Platform That Leverages Patient Wisdom and Data for 21st Century Biomedical Research
At today’s Stanford Medicine X conference, Dr. Stephen Friend, president of Sage Bionetworks announced funding and partnerships with three health communities for the development of BRIDGE, a cloud-based collaborative science platform designed to incorporate open data, patient wisdom and public involvement into biomedical research.
CHI’s 11th Annual Discovery on Target
Cambridge Healthtech Institute will host its 11th Annual Discovery on Target meeting showcasing current and emerging “hot” targets for the pharmaceutical industry from September 24-26, 2013 in Boston, MA. Spanning three days, the meeting attracts 700+ attendees, composed of scientists/technologists, executives, directors, and managers from biopharma, academic, and healthcare organizations. The meeting is comprised of 12 meeting tracks
FDA awards $20M IDIQ contract to PointCross Life Sciences for enhancing NIMS to review Nonclinical eData submissions in SEND and NIMS compatible formats
PointCross Life Sciences, Inc. announced that it has been awarded an IDIQ contract with a cap of $20 Million by the U.S. Food and Drug Administration to provide software development and life cycle management of NIMS (Nonclinical Information Management System) as well as to standardize current study submissions to enable reviews in NIMS.
Computer System Validation – Reduce Costs and Avoid 483s: 2-day In-person Seminar
This course benefits anyone that uses computer systems to perform their job functions and is ideal for regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors.
Accelrys Offers Novel, Integrated Predictive Sciences Solutions Enabling Faster, More Cost-effective Innovation for Life Sciences Organizations
Accelrys, Inc., a leading provider of scientific innovation lifecycle management solutions, has announced the availability of an extensive set of advanced predictive sciences applications and services. These integrated capabilities enable drug discovery teams to investigate and evaluate hypotheses about the chemical or biological behavior of molecules of therapeutic interest in silico prior to costly experimentation.
Laboratory Informatics Weekly Update – Volume 11, Issue 35
September 25, 2013 Laboratory Informatics Weekly Update Volume 11, Issue 35 In This Issue Event Focus 10/28/2013 - FAST: Functional Analysis & Screening Technologies Congress October 28-30, 2013, Cambridge, MA With the tremendous expense of bringing new drugs to market, a focus on improving the outcome of first-stage research is critical. Recent evidence confirms the need for innovative screening systems utilizing assay design on three-dimensional tissue models and phenotypic models. This functional analysis will allow for more accurate biological response. Cambridge Healthtech Institute is pleased to introduce FAST: Functional Analysis & Screening Technologies Congress to bring together drug research and…ILMAC 2013
ILMAC is an internationally recognized tradeshow for process and laboratory technology from the fields of pharmaceuticals, chemistry, food, beverages, cosmetics and biotechnology. ILMAC 2013 covers all the industrial applications of process engineering, including research, development, production, and environmental engineering. This trade show is an excellent opportunity to establish and nourish networking connections in Europe.
Valdata Launches Revised Chemical Management System Website at valdatasystems.com
Valdata Systems, the Chemical Management Systemprovider, has re-launched its website highlighting its core suite of software modules including Warehouse Management, Manufacturing Execution, LIMS and Recipe Development.
The website adds features specifically designed to help customers move more easily through the learning process and navigate the site, creating a reference source for those looking to solve problems in the areas of inventory and quality control. Two such additions are the Resources Page and Chemical Management Page.
9th Compound Management & Integrity Summit
The only conference dedicated to compound management concerns is back for the 9th time.
Join the compound management community in Boston, September 23-35 at the 9th Compound Management & Integrity Summit. This year, we are delivering strategies for ensuring compound integrity, efficient high-throughput screening and cutting-edge laboratory automation. With budgets tighter than ever, it is essential to have a well organized and low-cost compound management strategy to provide continuous support for the drug discovery pipeline.
International Mining Exhibition – EXPOSIBRAM 2013
With over 50,000 visitors and 500 exhibitors, the International Mining Exhibition (EXPOSIBRAM) and the Brazilian Mining Congress gather every two years hundreds of entrepreneurs, government and private organizations in a single place. In 2013, the events’ 15th edition organized by the Brazilian Mining Association (IBRAM - www.ibram.org.br) will be held from September 23rd to 26th, in Belo Horizonte (MG), Brazil
Accelrys Brings Next-Generation Decision-making to Scientific Discovery with Launch of Accelrys Insight
Accelrys, Inc., a leading provider of scientific innovation lifecycle management solutions, today announced Accelrys Insight and Accelrys Insight for Excel, completing the roll-out of Accelrys' next-generation cheminformatics suite and providing an interactive, collaborative environment for rapid and effective decision-making in drug discovery.
New Requirements for Sponsors and Laboratories for Analyzing Clinical Trial Samples to Meet GCP/GCLP Internationally
This webinar will help clinical laboratories, analyzing samples from clinical trials, understand the compliance requirements concerning ICH GCP for FDA and EMA (new requirements 2012) compliance.
Join RURO at IQPC – 9th Compound Management & Integrity Summit
Join RURO at IQPC - 9th Compound Management & Integrity Summit, Boston, MA, September 23-35, 2013
Thermo Fisher Scientific Showcases Workflow Configurable LIMS for Advanced Mining at EXPOSIBRAM 2013
EXPOSIBRAM 2013--Mining industry managers and laboratory technicians can improve laboratory process mapping, management and automation with new Thermo Scientific SampleManager 11 tools and user-interface enhancements. The newest, most configurable version of one of the world’s most widely deployed laboratory information management systems (LIMS) is featured within booth H15 at the Centro de Feiras e Convenções de Minas Gerais during EXPOSIBRAM 2013, being held September 23-26, in Belo Horizonte, Brazil.
Core Informatics Extends its LIMS, ELN and SDMS Platform with 4.2 Release
Core Informatics, a leading provider of data management solutions to the life sciences, molecular diagnostics and energy industries announced today the release of Core LIMS, ELN, SDMS version 4.2. This release further extends the configurability of the Core LIMS product and enables Core's customers to respond more promptly to their rapidly changing informatics needs.
Laboratory Informatics Weekly Update – Volume 11, Issue 34
September 18, 2013 Laboratory Informatics Weekly Update Volume 11, Issue 34 In This Issue SLAS 2014 09/18/2013 - Registrations is now open for SLAS2014 Registrations is now open for SLAS2014 SLAS2014 will feature all the great scientific education, programming, intelligent network building and new products and services you have come to expect from SLAS. Make plans to join us in San Diego, CA, January 18-22! Check out SLAS2014.org for the latest event details as they are announced. Register by October 31 to take advantage of the deepest discounts. http://www.slas2014.org/mediapartner Event Focus 10/28/2013 - FAST: Functional Analysis & Screening Technologies Congress…FDA Selects November Research Group’s PRIMO Software Platform as Next Generation Product Vigilance Solution
November Research Group, LLC, a global leader in the delivery of drug safety and pharmacovigilance services and software tools to pharmaceutical and life sciences organizations, today announced that the company’s PRIMO software platform has been selected as the new product vigilance software solution for the United States Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH).
The 11 Must-have Documents of Software Verification and Validation
This webinar focuses on the verification and validation planning and execution of software after basic developmental testing and de-bug. A suggested 11-element FDA model will be evaluated, implemented, with V&V documentation and test case examples.
