How to prepare for an OCR/HHS HIPAA/HITECH audit

This 60 minute online training will focus on HIPAA/HITECH Act requirements. It will help attendees prepare their organizations for periodic OCR/HHS audit by regulators

Laboratory Informatics Weekly Update – Volume 11, Issue 6

February 13, 2013      Laboratory Informatics Weekly Update  Volume 11, Issue 6   In This Issue  Bid / RFP / RFI Opportunities 01/28/2013 - Request for Proposal - Laboratory Information Management System (LIMS) City of Baltimore, Maryland - Request for proposals to provide software and services for the replacement of existing Laboratory Information Management System (LIMS) at its water and wastewater treatment plants.  Upcoming Webcasts 02/20/2013 - Webinar: Batteries Not Included - Looking Beyond the Informatics Quote The typical Lab Informatics vendor quote will contain information such as license costs, software implementation costs and possibly validation costs. In order for your Informatics…

New York Genome Institute Selects Exemplar LIMS to Manage Next Gen Sequencing Labs

Exemplar LIMS™ has been selected as the primary lab management and electronic lab notebook (ELN) solution for NY Genome Center's laboratory operations. Sapio's LIMS system will initially track next generation sequencing workflows from the Illumina family of sequencers from request through analysis. Support for additional next gen sequencers will be added as needed.

Definiens and Advanced Cell Diagnostics Introduce RNAscope SpotStudio™ – Early Access Program Started

Definiens and Advanced Cell Diagnostics (ACD) today unveiled the details of the RNAscope SpotStudio image analysis software to attendees at the Molecular Medicine Tri-Conference meeting in San Francisco, USA. The software has already been sold to a top pharmaceutical company and a leading academic medical center under an early access program.

Laboratory Information System for University Teaching Hospital in Zambia

This RFP solicits offers from qualified information technology software providers to implement a laboratory information management system (LIS) in a single site with multiple departments in Lusaka, Zambia. The successful proposal will provide a cost-effective LIS that can be maintained reliably in a timely manner and will offer an affordable solution that can be sustained in a resource-poor setting.

AspenTech Software Demonstrates Economically Viable Carbon Capture at World’s Largest CO2 Test Facility

Aspen Technology, Inc., a leading provider of software and services to the process industries, announced that Technology Centre Mongstad (TCM) is using aspenONE® software at the world’s largest industrial-scale facility for testing and improving CO2 capture technologies.

Molecular Medicine Tri-Conference 2013

February 11 - 15, 2013 - 20 Years of Advancing Applied Science and Technology

HIPAA Privacy In 2013 and Beyond

This HIPAA HITECH webinar will help you understand the requirements of HIPAA internet technology security (specifically to the electronic storage, transfer and use of patient information) and discuss the preparation for the Health Information Exchange (HIE) Network. Instruction as to best practices procedurally and electronically, to maintain a secure environment.

Introduction to Biotechnology Analytical Methods

This webinar will highlight the evidence normally requested during audits and inspections of biotechnology analytical labs. You will learn how your laboratory's biotechnology analytical methods can fulfill stated or implied regulatory requirements (the US FDA refers to these as the “C” in CGMPs).

Effective CAPA related to Managing Human Error

This CAPA training related to managing human error in regulated industries will explain the approach used in commercial nuclear and aviation industries and show how you can apply it successfully to manage human error in regulated pharmaceutical, biotech and medical device companies.

Best Practices in Responding to Form 483s

This webinar on Form 483 responses will cover strategies for FDA facility inspections and responses to inspectional findings. It will discuss tips on responding appropriately to avoid escalating most inspectional findings into a warning letter, including preparing for the top-ten 483 findings.

AQE 2013 registration now open!

Visitors to AQE 2013, the Air Quality and Emissions show (formerly ‘MCERTS’) taking place in Telford, UK, 13th/14th March, can now register for free at www.aqeshow.com .

JALA Names “The 2013 JALA Ten” Breakthroughs in Innovation

To honor scientific achievements that have made seminal impact toward addressing key biological and medical quandaries, the Journal of Laboratory Automation (JALA) has named The JALA Ten for 2013 in its February 2013 issue (Volume 18, Issue 1).

2-day In-person Seminar: Computer System Validation – Reduce Costs and Avoid 483s

This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments.Attendees learn how to decrease software implementation times and lower costs using a 10-step risk-based approach to computer system validation.

Interview with organization that built its own sample tracking system.

One option for a science company with unmet data management needs is to simply build a software solution from scratch. You might think that this would be strictly the domain of large well-resourced organizations, but even for a small business or startup this can be a possibility that can yield unexpected benefits. There are still places in the US where a lower cost of living means that software developers are not as expensive as they are in silicon valley, and with patience, persistence and a bit of luck, business owners can indeed find highly talented local individuals who can create a great solution even in the least "techie" of locales. In the following interview, I talk with key players at a small midwestern biotechnology company who needed a better way to manage their extensive collection of biospecimens. The company prefers to stay somewhat anonymous, so I have used pseudonyms; "The Biorepository" is the name of the business, "PM" is the primary project manager and biorepository specialist who helped with research and design, "Dev" is the software developer who made it all possible and "Tissue Database" or just "TDB" is the name of the solution itself. "Bob", is of course, yours truly, the author of this blog.

Social Media: Using The Legal Guideposts to Create Social Media Success (for Healthcare/Lifescience Companies)

This social media compliance training for healthcare companies will cover the legal and regulatory requirements governing the use of social media. A scenario-based learning approach will be used to show how to create a successful social media team by selecting members from relevant stakeholders, and prepare social medial policies and procedures.

Autoscribe announces Biobank data management seminars in the UK

Autoscribe has invited a number of biobanking experts to share their views and experiences on how to meet compliance regulations yet retain the flexibility to meet individual application requirements at three seminars to be held in the UK. These free, full-day seminars will be held in London on 7th March, Manchester on 12th March and Edinburgh on 23rd April. These seminars will be of particular interest to anyone involved in biobanks in biotechnology, pharmaceutical and medical research.

Global Medical Device Reporting – A Comparison of Worldwide Regulations

This webinar on global medical device reporting (MDR) regulations will cover recent updates from regulatory agencies worldwide and provide information on what to report, timing and format requirements, etc and how they differ between different countries.

Laboratory Informatics Weekly Update – Volume 11, Issue 5

February 06, 2013      Laboratory Informatics Weekly Update  Volume 11, Issue 5   In This Issue  Bid / RFP / RFI Opportunities 01/28/2013 - Request for Proposal - Laboratory Information Management System (LIMS) City of Baltimore, Maryland - Request for proposals to provide software and services for the replacement of existing Laboratory Information Management System (LIMS) at its water and wastewater treatment plants.  Articles Interview with organization that built its own sample tracking system. One option for a science company with unmet data management needs is to simply build a software solution from scratch. You might think that this would be strictly…

Capitol Hill Briefing on Value of Clinical Laboratory Testing

The foundation for 70% of physician decision-making, clinical laboratory tests are one of the most critical elements in preventing chronic illness, curtailing epidemics, and improving cancer care. At the same time, clinical lab tests are making the U.S. health care delivery system more cost-effective. On February 11, Kenneth Sisco, MD, Ph.D., medical director of Quest Diagnostics, will explore this topic at a Capitol Hill briefing for Congressional staff, members of the House and Senate, health care and patient organizations, and the news media in the visitors center of the U.S. Capitol building. The briefing is sponsored by "Results for Life," the educational arm of the American Clinical Laboratory Association (ACLA).
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