This 3-hour training will review and compare FDA’s Establishment Registration and Product Listing Requirements; and available User Fees, Fee Waivers and Marketing Exclusivity for Drugs, Biologics, Medical Devices, Food, Tobacco and Animal Health Products.

Sysmex America, Inc., a global leader in medical diagnostic testing equipment and healthcare information systems technology, today announced the introduction of an enhanced version of Sysmex WAM™ Decision Support Software for the Clinical Laboratory.

Today Blaze Systems announced a new release of its BlazeLink instrument interfacing middleware to interface any instrument to any LIMS/ELN/SDMS. Enhancements include additional graphical parsing instructions to simplify even more the translations from various instrument dialogs into standard XML, and built-in support for additional output fields to include supplemental values such as dilutions, MDL, and more.

The versatile Matrix Gemini Laboratory Information Management System (LIMS) from Autoscribe has been further enhanced through the addition of a facility for the automation of quality control samples and how they are grouped together. Accessed through either Matrix Gemini’s web or Windows interface, this is an enhancement of the existing ‘runsheet’ function and provides the ability to create runsheet templates and automatically build runsheets from those templates as well as performing standard QC calculations.

Autoscribe LIMS - THE UNIQUE LIMS EXPERIENCE
Please stop by booth #3859, to see ALL of our proven solutions and discuss how Autoscribe Informatics can deliver real benefits to your company.

This webinar on drug price reporting will discuss the changes to the Medicaid Drug Program and its impact on pharmaceutical and biotech companies.

This webinar on automating laboratory assays will teach you how to translate an assay that is performed manually to one that is fully automated, with high quality and with proper validation and quality assurance for regulatory purposes.

This 3 hour virtual seminar will help you create an integrated medical device software development process that will meet IEC 62304 and ISO 13485 design control requirements, and generate the documentation needed for software as part of a FDA submission.

To address the urgent need to use encryption for HIPAA compliance, data protection software developer Jetico has announced the release of BestCrypt Base. Built on Jetico's superior whole disk encryption, BestCrypt Base prevents data breaches from lost or stolen computers containing electronic protected health information (ePHI).

The 2014 Annual HIMSS Conference & Exhibition, February 23-27 in Orlando, brings together 37,000+ healthcare IT professionals, clinicians, executives and vendors from around the world. Exceptional education, world-class speakers, cutting-edge health IT products and powerful networking are hallmarks of this industry-leading conference. More than 300 education programs feature keynotes, thought leader sessions, roundtable discussions and e-sessions, plus pre-conference workshops and symposia.

Exostar, whose cloud-based solutions enable secure, cost-effective business-to-business collaboration, today announced significant milestones in the adoption of its community cloud access and collaboration service offering for the Life Sciences industry. Led by two of the ten largest global pharmaceutical companies, more than 500 organizations supporting over 10,000 individuals in 46 countries on six continents are leveraging Exostar’s Life Sciences Identity Hub and Secure Access Manager (SAM) to safely, securely, and cost-effectively collaborate in the cloud.

This training on clinical audit will teach attendees how to prepare for audit and ensure readiness at all times.

This webinar on FDA electronic filings will discuss and provide clarification on the process of submitting drug establishment registration and drug listing information to the FDA using its Electronic Submission Gateway (ESG).

RURO Booth # 4262

CSols, Inc. Webinar: The FDA expects regulated laboratories to ensure their systems are reliable and perform as designed. Validating Lab Informatics systems present unique challenges, challenges that add to the existing challenges of validating other information systems. What additional skills are required to validate laboratory systems versus other types of regulated business systems?

The webinar will familiarize participants with the FDA's Refuse to Accept Policy for medical device 510(k)’s and help you ensure that your 510(k) application is not rejected for lack of administrative completeness.

The webinar will discuss best QC practices and procedures for verifying the suitability and performance characteristics of microbiological media and reagents.

This workplace safety compliance training will explain OSHA’s initiative to protect temporary workers. It will also provide you the tools to ensure compliance with OSHA requirements when employing temporary workers.

Leading healthcare portal software Bridge Patient Portal is announcing a partnership with the X-Link Solutions Network to improve Bridge's access to the X-Link compatible EMR/EHR systems databases and to help the portal interface even more seamlessly with them.

This training will show how you can handle customer complaints in compliance with FDA and ISO Regulations. The instructor will discuss the best ways to document customer feedback, what constitutes a complaint, what do with "non-complaint" feedback, and how to include complaint trending into your firm’s CAPA program.