Submitting FDA Electronic Regulatory Filings – Drug Establishment Registrations and Drug Listings
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).
Laboratory Informatics Weekly Update – Volume 12, Issue 7
February 20, 2014 Laboratory Informatics Weekly Update Volume 12, Issue 7 In This Issue Articles What is a Laboratory Information Management System (LIMS) Exactly? A Laboratory Information Management System, more commonly referred to as a LIMS, is a software system designed to help manage the workflow and daily operations in a laboratory. Although each LIMS provider designs their software a bit differently, at its core, the system focuses on data management in regards to specimen testing and results reporting. Webcast Focus 03/26/2014 - Autoscribe - How to Buy a LIMS webinar Autoscribe, a leading developer of Laboratory Information Management Systems…See RURO solutions at Pittcon 2014, March 3-6, 2014, Chicago, IL
RURO Booth # 4262
CSols, Inc. – Complimentary Webinar Lab System Requirements
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?
Understanding the FDA ”Refuse to Accept” guidance to avoid administrative rejection of your 510(k)
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.
Quality Control for Microbiological Media and Reagents
The webinar will discuss best QC practices and procedures for verifying the suitability and performance characteristics of microbiological media and reagents.
OSHA Enforcement for Employers Using Temporary Workers
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.
Bridge Patient Portal Partners with X-Link for Improved Medical Software Interfacing
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.
Complaint Handling in Compliance with FDA and ISO Regulations
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.
JusticeTrax® Unveils LIMS-plus DNA Forensic Science Laboratory Software
JusticeTrax, Inc. adds LIMS-plus DNA to its suite of software applications designed for forensic science laboratories.
Laboratory Informatics Weekly Update – Volume 12, Issue 6
February 13, 2014 Laboratory Informatics Weekly Update Volume 12, Issue 6 In This Issue Webcast Focus 02/19/2014 - CSols, Inc. - Complimentary Webinar Lab System Requirements 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? Recent News 02/12/2014 - SLAS Announces 2014 JALA & JBS Art of Science Contest Winner The Society for Laboratory Automation and…Agilent Technologies Expands Next-Generation Sequencing Target-Enrichment Platform with SureCall Software Upgrade
Agilent Technologies Inc. (NYSE:A) today introduced SureCall version 2.0 software, expanding the capabilities of the company’s current market-leading, next-generation sequencing target-enrichment solutions. The newly upgraded software features compatibility with SureSelect custom target-enrichment and Human All Exon panels.
RURO Announces New Training Services – Complimentary Program and “On Demand”
Due to increased demand for RURO’s Enterprise Training Program for systems FreezerPro®, Sciency® and ezColony®, RURO is excited to announce two enhancements that may streamline the user adoption process for its new or returning users. The first is a complimentary Enterprise Training Program now included with every new FreezerPro or other Enterprise system license purchase. The second is the availability of RURO’s new “On-Demand” Online Training Portal.
Staying Ahead of the OIG: Best Practices in avoiding Fraud and Abuse and Civil Fines and Penalties
This webinar will discuss how to review the OIG Strategic Plan for 2014-2018 and recent cases of enforcement in the area of Fraud and Abuse. This session will cover the best practices and a compliance plan that can help you avoid these pitfalls and penalties.
FDA Premarket Application Pathways for E-Cigarettes and Other New Tobacco Products
This webinar will discuss the different premarket pathways for new tobacco products, including the Premarket Tobacco Application, the Substantial Equivalence Report and the Minor Modification Exemption.
So you’ve had a visit from OSHA, Now What?
This training on OSHA inspection will focus on Abatement Verification Regulation (29 CFR 1903.19) and importance of abatement. Learn best practices to avoid penalties for failure to abate.
SLAS Announces 2014 JALA & JBS Art of Science Contest Winner
The Society for Laboratory Automation and Screening (SLAS) announces that Tomasz Koprowski of the Institute for Chemical and Bioengineering in Zurich, Switzerland, is the grand prize winner of the 2014 JALA & JBS Art of Science Contest.
3-hr Virtual Seminar – Japan: Regulatory Compliance Requirements for Life Science Products
This 3 hour virtual seminar on Japan regulatory compliance requirements will explain the country's regulations and processes (including clinical trials, filings, etc.) and use real world experiences to show how compliance issues are culturally handled for life science products in Japan.
OSHA Process Safety Management (PSM) compliance directive (CPL) and interpretations review
This 90-minute webinar will help you understand the application and requirements of OSHA Process Safety Management and the topics that have been interpreted and reviewed in the compliance guidelines.
Verification vs. Validation in Regulated Industries
This webinar on verification vs. validation will help you to understand the differences between, and benefits of, verification and validation in both design and process operations in regulated industries. Learn about the risks and complications involved with the application of sound verification and validation principles.
