FDA Regulation in Pharmacy Compounding – Risks and Critical Issues to Consider

This webinar on FDA Pharmacy Compounding will detail the current thinking, the efforts made and steps taken by FDA and legislatures since the “meningitis outbreak” in 2012.

Abbott Introduces New Laboratory Information System Software to Help Users Access Data from Anywhere

Abbott announces the global launch of version 11 of the company’s STARLIMS software-based laboratory information management system (LIMS). The new version expands user functionality to include mobile device applications, advanced analytics, and HTML5 compatibility, enabling users to access LIMS information anywhere on any screen.

Laboratory Informatics Weekly Update – Volume 11, Issue 40

October 30, 2013      Laboratory Informatics Weekly Update  Volume 11, Issue 40   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  Webcast Focus 11/20/2013 - CSols Webinar: Lab Informatics and FSMA Compliance…

CAPA for Clinical Trials – How to Respond to Audit and Inspection Findings

This CAPA training for clinical research personnel will help attendees understand how to respond to inspection and audit findings using a Corrective and Preventative Action (CAPA) plan.

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 development teams for practical discussion, solutions and case studies for refining these first-stage drug discovery methods.

Raw Materials Risk Management in GMP Facilities: Avoiding GMP non-Compliance Due to Raw Material Issues

This FDA GMP training will help you understand the current requirements for raw material management with tips for practical implementation. It covers FDA’s expectations from GMP facilities regarding raw material vendor selection, measures for assuring acceptable quality of material supplied, expectations from quality control and documentation processes, and training requirements, with case studies.

CLIA (Clinical Laboratory Improvement Amendments) Guidelines on Quality Control and Quality Assessment

This Clinical Laboratory Improvement Amendments (CLIA) training will be valuable to CLIA regulated, non-waived laboratories that run automated analyzers or semi-quantitative kit tests. It will highlight differences between quality control and quality assessment and the proper methods to meet CLIA guidelines.

Research and Markets: Global Lab Automation Analysis to 2017: Automated Liquid Handling & Robotics, Microplate Readers, LIMS and Automated Storage

Research and Markets (http://www.researchandmarkets.com/research/r7gqg3/lab_automation) has announced the addition of the "Global Lab Automation Analysis to 2017" report to their offering.

SLAS2014 Welcomes 46 Students Through the Tony B. Academic Travel Awards Program

In service of its educational mission and to serve life sciences R & D professionals around the world, the Society for Laboratory Automation and Screening (SLAS) honors 46 undergraduate students, graduate students, post-doctoral researchers and junior faculty members with SLAS Tony B. Academic Travel Awards for SLAS2014, the Third Annual SLAS Conference and Exhibition, which will be held Jan. 18-22, 2014, at the San Diego Convention Center in San Diego, Calif., USA.

Dataworks Development Releases Freezerworks Unlimited 6.0

Dataworks Development, Inc. announces the release of a major new upgrade, version 6.0, to its Freezerworks Unlimited freezer inventory and sample management software program.

The 6 Most Common Problems in FDA Software Validation & Verification

This FDA Software Validation and Verification training/webinar will review the validation planning process with particular emphasis on avoiding six common pitfalls.

Transferring Medical Device Production to a Contract Manufacturer

This webinar on outsourcing medical device manufacturing will discuss practical decision making steps you can follow to analyze whether to transfer or invest in keeping production in-house. If you decide to transfer production, then this training will detail the options and next steps to transferring it to the right facility or contract manufacturer.

BIOBASE Launches PharmacoGenomic Mutation Database (PGMD™) – a Knowledge-base Containing Genetic Variants that Affect Drug Response

BIOBASE Corporation, the leading provider of expert-curated biological databases, software and services for life science researchers, today announced the release of PGMD™ at the American Society of Human Genetics (ASHG) annual meeting in Boston, MA. PGMD is a database of detailed genotype-phenotype relationships derived from in vivo pharmacogenomic patient studies, stemming mostly from clinical trials, with insights pertaining to response rate, risk of adverse events, realization of expected outcomes (e.g. patient survival), pharmacokinetic parameters such as dose requirements, and much more.

New Software Traces Origins of Genetic Disorders 20 Times More Accurately

In a bioinformatics breakthrough, i Minds - STADIUS - KU Leuven researchers have successfully applied advanced artificial intelligence to enable the automated analysis of huge amounts of genetic data . Their new s oftware suit e, eXtasy , automatically generates the most likely cause of a given genetic disorder . The breakthrough directly impacts the treatment of millions of people with a hereditary dis ease.

Writing your Company’s Safety Plan: I2P2 (Illness and Injury Prevention Plans) – What you Need to Know and Do

This webinar will be a basic, nuts and bolts program leading participants through the process of creating a written safety plan for evacuation, fire, hazard communication and Others, that complies with OSHA requirements.

European Institute of Oncology Implements Thermo Scientific LIMS for Biobanks

International cancer care and research biobank uses Thermo Scientific LIMS to integrate data and streamline workflows.

The European Institute of Oncology (IEO), a Milan, Italy-based organization committed to making an active contribution to fighting cancer--particularly tumors of the breast, lung, prostate and bowel--has implemented a new laboratory information management system (LIMS) to more efficiently manage its biospecimen data.

LIMS Customer Survey Results Announced

Autoscribe has recently conducted a satisfaction survey with its Laboratory Information Management Systems (LIMS) customers worldwide. Autoscribe’s CEO, John Boother, said: “Producing management software suitable for use in wide and varied laboratory environments requires much more than just programming skills. We wanted to understand our customers’ feelings about all the aspects of our business, from the sales experience through implementation and support services as well as the quality of the software itself.”

Laboratory Informatics Weekly Update – Volume 11, Issue 39

October 23, 2013      Laboratory Informatics Weekly Update  Volume 11, Issue 39   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…

Managing the Software Development Life Cycle to Produce Regulatory Documentation (for Medical Devices)

This webinar will discuss regulatory requirements for the medical device software development process and how the documentation needed for MDD technical files and for FDA submission can be developed as part of that process.

BioDatomics Increases NGS Research Productivity with Launch of up to 100 Times Faster, More Intuitive Data Analysis Software

BioDatomics today introduced the company’s first commercial product, BioDT™, an open source suite of next generation sequencing (NGS) data analysis software and services. The new platform addresses the shortcomings found with current data analysis offerings by delivering much higher performance and an intuitive interface, thereby enabling genomic and biomedical researchers to more quickly glean meaningful insights from their data.
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