An Introduction to FDA’s Regulation of Over-the-Counter (OTC) Drug Products
This webinar will provide an introduction to the FDA’s regulation of Over-the-Counter (OTC) drug products and the various methods for bringing such a product to market. You will learn the various options for marketing an OTC drug, gain an understanding of FDA’s relevant labeling and promotional rules, and learn strategies for mitigating the potential risk for FDA regulatory enforcement.
Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing
This 90-minute webinar will show how you can design a robust microbiological audit program for pharmaceutical and biopharmaceutical product manufacturing, that effectively assesses your facility and that of your supplier to ensure your facilities and products are free from microbial contamination.
Dotmatics Releases Sample Tracking and Resource Management Solution
Dotmatics, a leading provider of scientific informatics solutions and services, is pleased to announce the release of Cascade, its new web-based test request and tracking application. Cascade is a configurable solution that maps laboratory workflows and business practises, even if they change regularly.
Social Media Trends, Best Practices and Compliance for Healthcare Professionals
This social media training for healthcare professionals will provide attendees best practices to ensure compliance with social media policies and avoid HIPAA violations and the resulting penalties and lawsuits.
Medical Foods: Understanding what Constitutes a Medical Food for FDA Regulatory Purposes and Strategies for Successfully Commercializing such Products in the U.S.
This training on medical foods will provide an introduction to FDA’s regulation of medical products, assist you in identifying when it may be appropriate to market a product as a medical food; recommend strategies for marketing such products; and summarize recent FDA enforcement actions in the area to help companies mitigate the risk of potential Agency enforcement action.
Clarity LIMS to Support Illumina HiSeq X™ Ten
GenoLogics Life Sciences Software, a leading provider of laboratory information management systems (LIMS) specifically designed for omics labs, announced today that the coming release of Clarity LIMS will support next generation sequencing workflows and integrations for the Illumina HiSeq X™ Ten. The functionality will be used and beta-tested by the Garvan Institute of Medical Research in Sydney Australia.
Blaze Systems Releases BlazeLIMS SaaS For a Fast Track, Risk Free LIMS.
Blaze Systems Corporation announces the release of BlazeLIMS SaaS for a risk-free fast track to BlazeLIMS automation and benefits. BlazeLIMS SaaS removes the barriers to the breakthrough improvements in laboratory effectiveness that BlazeLIMS, a comprehensive COTS LIMS, provides to a laboratory by automating and streamlining operation and data management.
Khemia Software to Exhibit at PITTCON 2014 Conference & Expo in Chicago March 2-6,
Khemia Software will be onsite at PITTCON, the premier venue for the laboratory science industry held March 2-6 at McCormick Place in Chicago to show attendees the value of Khemia’s premier provider of Laboratory Information Management Systems (LIMS) and software solutions. Come see us at Booth # 3862
California Environmental Regulations – Differences Between Federal EPA and State Requirements
This environmental regulation training will explain in details the differences between California Environmental Regulations and U.S. EPA and Other State Requirements.
Legal Writing Skills to Prepare for Effective Regulatory Submissions – FDA, EU EMEA and EU Notified Body
This training on legal writing for regulatory submissions will provide practical tips that have proven to enhance the persuasiveness of regulatory submissions and help you succeed even if some of your test results or other supporting information are lacking.
SLAS2014 Attendance Breaks Records for the Society
The Society for Laboratory Automation and Screening (SLAS) welcomed a record-setting 5,819 participants from 46 countries to SLAS2014, the Third Annual SLAS Conference and Exhibition, at the San Diego Convention Center in San Diego, Calif., Jan. 18-22, 2014. This five-day annual event convened scientists, academicians, business leaders and students from around the globe to gain new information, ideas and insight about laboratory science and technology.
New case study highlights LIMS tracking capabilities
A new case study, describing the use of the Matrix Tracker software in the mortuary in an NHS Hospital Trust, has been published by Autoscribe Ltd and is available for download.
Laboratory Informatics Weekly Update – Volume 12, Issue 4
January 29, 2014 Laboratory Informatics Weekly Update Volume 12, Issue 4 In This Issue Recent News 01/29/2014 - Khemia Software to Exhibit at PITTCON 2014 Conference & Expo in Chicago March 2-6, Khemia Software will be onsite at PITTCON, the premier venue for the laboratory science industry held March 2-6 at McCormick Place in Chicago to show attendees the value of Khemia’s premier provider of Laboratory Information Management Systems (LIMS) and software solutions. Come see us at Booth # 3862 01/29/2014 - Blaze Systems Releases BlazeLIMS SaaS For a Fast Track, Risk Free LIMS. Blaze Systems Corporation announces the release…PHT Corporation to Showcase the LogPad App™ for Collecting Secure Clinical Research Data from Patients’ Android and Apple Smartphones, at SCOPE Summit for Clinical Ops Executives
PHT Corporation will demonstrate its market-changing LogPad App system for collecting secure patient-driven eData on the latest smartphones at the SCOPE Summit in Miami next month. PHT is the leading provider of technologies used to collectpatient-driven eData for clinical research.
Changing Supplier Controls Requirements
This training on FDA supplier controls will help you refine your supplier chain management and vendor audits to match the FDA's tougher position. We will evaluate the chief areas of change to see how to better prepare a supplier chain management and audit program.
3-hr Virtual Seminar: Latin America – Understanding Regulatory Compliance Requirements Across the Life Science Industry
This Latin America regulatory compliance requirements training will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America.
Get Approval to Attend PITTCON 2014 – With CSols, Inc. Laboratory Informatics Training
CSols, Inc. the premier Laboratory Informatics Consultancy in North America understands the complex challenges that today’s modern Laboratories face. As a result, CSols has developed five short courses to be presented at PITTCON 2014 on some of these critical business issues. These Short Courses provide both the training and tools that Laboratory and IT personnel can leverage to solve these business issues in their respective labs.
Writing Effective Clinical Evaluation Reports as Part of Post-Market Surveillance
This medical device webinar will discuss strategies for meeting the Post Market Surveillance requirements as described in Annex X of the MDD (MDD 93/42/EEC, updated per the 2007/47/EEC M5 amendment, Annex 1: Essential Requirements), MEDDEV 2.7.1, Dec 2009 and ISO 14155.
Dairy.com Announces Acquisition of QA Studio
FRISCO, Texas--(BUSINESS WIRE)--Web-based dairy supply chain solutions and market intelligence leader Dairy.com today announced the acquisition of QA Studio, a quality assurance and food traceability software provider to the dairy industry.
Effective Training Practices for FDA Compliance
This FDA compliance webinar will help the attendees develop an effective training program and training plans for an organization. Attendees will learn GxP training requirements in US and EU.
