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New FDA Rule Regarding Medical Device Data Systems Takes Effect _________________________________________________________
A new U.S. Food and Drug Administration rule went into effect April 18 that regulates how hardware manufacturers can introduce new mobile medical devices for use by health care providers. The rule was promulgated by the FDA's Center for Devices and Radiological Health, which oversees regulations for companies manufacturing, repacking, relabeling or importing medical devices in the United States.
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Free Download: The Increasing Need for Transparency, Patient and Public Engagement in Health Technology _________________________________________________________
Jeff Waite, contributing author and Director of Knowledge Management at Stelerix, shares an in-depth interview with health economist Leela Bartham on the importance of patient and public engagement to promote transparency in health technology.
Read complete article.
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Life Science Companies' Concerns About Social Media Remain Justified
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Consumers increasingly rely on the Internet and social media outlets such as Facebook, Twitter and Wikipedia for health information. In 2009 alone, more than 80 million consumers, about 35 percent of all U.S. adults, used social media for health and medical purposes.
Despite consumers' growing dependence on this medium for health information, the Food and Drug Administration (FDA) has not yet issued definitive regulations or guidelines addressing drug and device manufacturers' use of social media to market their products. For this reason, companies understandably have been reluctant to use social media to provide even the most basic information about FDA-regulated products for fear of criminal investigations, government fines and civil lawsuits.
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Free Download: The Secrets of Team Facilitation
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More and more businesses are turning to work teams to improve their processes, products and services-- and for good reason. When teams work well, they are more likely to produce creative breakthroughs and practical solutions than when employees labor alone.
On the flip side, when teams do not work well together, the results can have a comparable negative effect. This white paper outlines the secrets of team facilitation and what managers can do to improve the quality of output from employees in their organization.
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Med-tech's Dilemma: Safety vs. Innovation
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For Katie Korgaokar, recalls were for dishwashers and cars, not body parts. So when the surgeon who implanted her "state-of-the-art" artificial hip sent her a letter saying the device had been recalled and he would have to cut it out of her, the Denver woman was flabbergasted.
Regulators, businesses, politicians and patients have battled for years over whether America's public health is better served by avoiding risks or by faster innovations in the medical device industry. Evidence is incremental and contradictory.
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Survey: How has the new medical device tax impacted your company? _________________________________________________________
The health care reform law and its excise tax on medical device sales is already driving companies to seek lower-cost areas to plant their flags in, according to Princeton, N.J.-based research firm The Boyd Co. Inc.
How has your company been impacted by the new medical device tax?
Take our poll.
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Monthly Newsletter
PathWise, Inc.
April 2011
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Upcoming Events
CAPA Workshops for Life Sciences
These 2-day courses are designed to meet the requirements mandated by regulatory agencies to effectively investigate and locate causes and correct them.
May 17-18, 2011
Lugano, Switzerland
August 3-4, 2011
Boston, MA
October 12-13, 2011
Newport Beach, CA
For more information or to register.
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Audit Management
This 2-day course is designed to to train and prepare individuals to manage the quality audit process through reading, lecture, discussion, role playing, and practical exercises.
May 17-18, 2011
Lugano, Switzerland
August 1-2, 2011
Boston, MA
Documenting Investigations
These one day courses teach proven technical writing techniques and tools that will meet regulatory expectations.
May 13, 2011
Dublin, Ireland
PathWise Webinars
Integrating FDA and Trending
Requirements into your CAPA System
Best Practices to Manage an FDA Inspection
Conducting OOS and Non-Conformance Investigations
Integrating ISO 14971 and ICH Q9 into the Quality System
Download webinars.
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New Training Course! Audit Management _______________________________________________
Understanding how to conduct a thorough quality audit is an essential control measure for any organization. Unfortunately, many organizations do not have the luxury of hiring well-seasoned professional auditors-- they must develop them from within. In Audit Management, we teach you how to thoroughly manage a quality audit, sharing insight into pertinent regulatory requirements, as well as the necessary planning, performance and post-audit remediation techniques.
Learn more.
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Facing an uphill battle?
PathWise is a training and consulting firm that works with medical device, pharmaceutical and biotechnology companies in the areas of quality and compliance. We deliver the methodology and tools to ensure compliant, effective and efficient execution of quality system requirements.
Problem Solving Risk Management Documentation
CAPA Quality Systems Regulation Auditing
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Please visit us online at www.PathWise.com or call 866.580.PATH for more information.
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