Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina): 2-day In-person Seminar
This two-day comprehensive Course on Latin America Regulatory compliance requirements will cover topics ranging from pre-clinical and clinical requirements through product registration, amendments and renewals across Pharmaceuticals, Biologics, Medical Devices and Combination Products. The Course will address the structure of the regulatory agencies in Latin America and discuss local cultural nuances to help you be successful in working with the regulators.
Cenetron Announces Launch of ARCHIVA BioLogistics
Archiva Biologistics will focus on the design and manufacture of clinical collection kits, innovative laboratory requisition documents, sample logistics, and sample storage. All facets of Archiva are operationally linked and managed with GlobeSyncTM, an enterprise-wide 21-CFR-part 11 compliant Laboratory Information Management System, and Manufacturing software platform. GlobeSync is a proprietary software system and data portal developed at Cenetron Diagnostics.
Definiens and Advanced Cell Diagnostics Launch Software for Quantitative RNA In Situ Hybridization
Definiens AG, a healthcare company that advances personalized medicine through image analysis and digital pathology solutions, and Advanced Cell Diagnostics (ACD) of Hayward California, a leader in molecular pathology, announced recently the commercial launch of RNAscope® SpotStudio™, a custom-designed image analysis software application for ACD's RNAscope®Assays to detect and quantify RNA biomarkers.
Foreign Clinical Trials not conducted under an IND (21 CFR 312.120)
This webinar will discuss requirements for acceptance of foreign clinical studies, the guidance for foreign investigator qualification, foreign research facility requirements and study monitoring documentation.
Understanding the New USP Chapter <1224> for Transfer of Analytical Methods
This webinar will explain the final version of USP Chapter and FDA guidance for conducting and documenting method transfer between laboratories and sites, and provide tools for effective implementation.
CSols, Inc. Webinar: Delivering a Successful Laboratory Informatics Project
Don’t leave the outcome of your informatics project to chance. Dramatically improve your odds of success with proper planning techniques. Spend an hour learning how to use a proven process to increase your chance of success.
All new LIMS Book & Buyer's Guide released on-line for 2013/14
The
new on-line edition of the LIMS Book & Buyer's Guide (http://www.limsbook.com)
has just been released today with over double the number of listed vendor
products from the 2012 edition.
The
guide provides a catalog of the industry's top tier vendors with product pricing
information and technical details to allow you to compare LIMS/LIS and ELN
products. The guide also contains a LIMSpec on each listed product with even
more technical details as well as product demonstration videos.
Laboratory Informatics Weekly Update – Volume 11, Issue 33
September 11, 2013 Laboratory Informatics Weekly Update Volume 11, Issue 33 In This Issue LIMS Blog Postings All new LIMS Book & Buyer's Guide released on-line for 2013/14 The new on-line edition of the LIMS Book & Buyer's Guide ( http://www.limsbook.com) has just been released today with over double the number of listed vendor products from the 2012 edition. The guide provides a catalog of the industry's top tier vendors with product pricing information and technical details to allow you to compare LIMS/LIS and ELN products. The guide also contains a LIMSpec on each listed product with even more technical…Effective CAPAs: How to Avoid Scrutiny in FDA’s Latest Area of Focus
This 60-minute CAPA training will provide participants an insight into FDA’s recent focus on effectiveness of CAPAs and how to manage your CAPA program to avoid the dreaded 483 observation.
The Hero of Manufacturing Contamination Control – The Microbiology Lab
This webinar on Contamination Control will discuss, how the micro lab can be more effectively utilized to prevent or head off microbial contamination issues as well as effectively resolve problems like recurring micro failures, investigations, and ineffective CAPAs.
Accelrys Transforms Innovation by Bridging Cheminformatics and Bioinformatics
Accelrys, Inc., a leading provider of scientific innovation lifecycle management software, has announced the completion of an initiative to standardize chemical structure perception across the Accelrys Enterprise Platform and the Accelrys Direct data cartridge for Oracle. Harmonized cheminformatics technology from Accelrys enables scientists to represent molecules, reactions, biologics and conjugates consistently across applications developed using the Accelrys Enterprise Platform and Accelrys Direct.
Adaptive Computing to Work with Atipa Technologies to Manage Computing Workloads at Department of Energy’s Environmental Molecular Sciences Laboratory
Adaptive Computing, the largest provider of policy-based optimization software for High-Performance Computing (HPC) and private cloud, today announced it will work with Atipa Technologies to manage a new supercomputing environment for the Environmental Molecular Sciences Laboratory (EMSL), a national scientific user facility at the Department of Energy’s Pacific Northwest National Laboratory (PNNL) in Richland, Wash.
ACD/Labs Announces the Release of ACD/ChemAnalytical Workbook
ACD/Labs, a leading chemistry software company that develops and commercializes enterprise and desktop solutions to support R&D efforts, and preserve and re-use legacy chemical and analytical knowledge, today announced the commercial availability of ACD/ChemAnalytical Workbook. This new software application on the ACD/Spectrus Platform provides an all-in-one experiment, workflow, and data management tool for scientists that use multiple analytical techniques in a problem-solving capacity, in industries including coatings, lubricants, fragrances, forensics, petrochemicals, food, and formulated healthcare products.
Countdown to HIPAA Compliance: Preparing for the September 23, 2013 Deadline
This webinar will explain the changes that every health care-related entity should make to their policies and procedures and their Notices of Privacy Practices, to reflect the new HIPAA rules, before the September 23 deadline.
Laboratory Informatics Weekly Update – Volume 11, Issue 32
September 05, 2013 Laboratory Informatics Weekly Update Volume 11, Issue 32 In This Issue Webcast Focus 09/18/2013 - CSols Webinar: Lab Informatics and FSMA Compliance This one's for the Food & Beverage Industry: We'll be taking a look into the passing of the Food Safety Modernization Act and how the FDA has significantly heightened the requirements for all companies who produce, manufacture, process, pack, transport, or hold food. 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…Biobank Data Management
Autoscribe will be showing the Matrix Gemini Laboratory Information Management System (LIMS) at ESBB 2013. This provides a highly configurable environment that needs no custom coding and is suitable for all aspects of biobank and biorepository management in biotechnology, pharmaceutical and medical research. A data management solution can be designed quickly to represent exact user requirements in terms of workflows, screen designs, menu designs, terminology, report designs and much more.
SLAS Expands Global Operations with New Office in Europe
The Society for Laboratory Automation and Screening (SLAS) is proud to announce the opening of the Society’s European office in Brussels, Belgium. The SLAS Europe office becomes the Society’s third on three different continents, joining operations in Shanghai, China, and SLAS Global Headquarters in suburban Chicago, Illinois, USA.
RURO Adds Critical Level Monitoring Functionality to its Transgenic Animal Management Software ezColony.
RURO, Inc., a developer of research software and inventory solutions introduces a second additional module to its ezColony software.
Developed specifically for growing breeding and transgenic laboratories, the Advanced Alerts Module allows users to send custom notifications to designated contacts, such as when animal count falls below a pre-defined level. This critical level monitoring makes tracking animal lines and breeding or replenishment order timing even easier.
Matrix Gemini Offers Both LIMS And Business Quality Management
Autoscribe will be showing the Matrix Gemini Laboratory Information Management System (LIMS) at Lab Innovations 2013. However, Matrix Gemini is much more than an easily configurable LIMS for applications in a wide variety of laboratories including, food, pharmaceutical, chemicals, veterinary, healthcare, and environmental information management systems. It also provides a systematic quality management resource for tracking, storage, auditing and reporting of data across all segments of a business or company.
Ventana and EMC join forces to take digital pathology into the world of Big Data
Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, today announced that it has entered into an agreement with data storage and IT infrastructure industry leader EMC Corporation (EMC) to offer a highly scalable and flexible solution to store and archive medical images as part of the VENTANA digital pathology solution for anatomical pathology labs.
