Market for Re-manufactured Devices on the Rise
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Both Ascent Healthcare Solutions and SterilMed Inc., the nation's two predominant reprocessing firms, confirmed that interest in and use of remanufactured devices among hospitals has grown rapidly over the past few years. It's a trend that's expected to continue - and one the companies are attributing to several key factors: an increased awareness of the safety and efficacy of reprocessing; more stringent federal oversight of the industry; and reprocessing's ability to help facilities cut costs and leverage the supply chain for maximum savings, while simultaneously having a positive effect on the environment. Read the article. |
Quality System Regulations and FDA Expectations
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A solid understanding of QSR is necessary for device manufacturers to avoid violations, keep products safe and on the market. All medical device manufacturers must comply with the Quality Systems Regulation (QSR) in order to market products in the US, yet many fail to meet these industry requirements.
Former FDA field investigator Lisa Hornback provides a detailed overview of QSR, including the scope of FDA's responsibility, areas of FDA focus, and common areas of struggle faced by device manufacturers.
View the webinar. |
Should Pharma Follow FDA's Lead on Twitter Usage? __________________________________________
Many pharmaceutical corporate Twitter accounts are devoted to posting news about the company, including news about new research results relating to its products. In these tweets, product names are mentioned as well as the research results, but no fair balance information is included. Such tweets include links to press releases and include high risk information about the company.
With the rise of social media and Twitter usage in life science companies today, we are left to where the boundaries are and what constitutes a violation of FDA regulation.
Read the article. |
Community Poll: Which of the following is a top priority in your Supplier Quality Management plan?
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Supplier quality management has emerged as one of the leading business practices in the past few years, and is a crucial subset of the organization's overall quality system. To improve client satisfaction and avoid regulatory scrutiny, manufacturers are making significant investments in systems and processes to improve supplier quality.
Which of the following is a top priority in your Supplier Quality Management plan?
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Last Month's Poll Results: Five Whys is Most Common Tool When Conducting RCA
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Last month, we issued a poll asking "What is the most common tool your investigators use when conducting a root cause analysis??"
Here are the results from the life science manufacturers worldwide:
#1 Five Whys
#2 Fishbone
#3 Is/Is not
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Monthly Newsletter
PathWise, Inc.
March 2010 |
CAPA Workshops for Life Sciences
These 2-day courses, taught by former FDA Investigators, PathWise, and MasterControl industry experts, are designed to meet the requirements mandated by regulatory agencies to effectively investigate and locate causes and correct them.
Dublin, Ireland
June 16-17, 2010
Boston, MA
Tokyo, Japan
PathWise Webinars
Integrating ISO 14971 and ICH Q9 into the Quality System
This webinar provides insight into the necessary industry standards and offers meaningful techniques that risk management professionals can use to implement ISO 14971 and ICH Q9 into their quality system.
For more information or to purchase.
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Integrating FDA and Trending Requirements into your CAPA System
This session offers attendees a "how-to" approach to effectively integrate the FDA's CAPA and Trending requirements, providing them with the skills necessary to develop a strong, sustainable and compliant CAPA system.
For more information or to purchase.
Conducting OOS and Non-Conformance Investigations
This webinar provides a process to effectively expedite and document OOS and non-conformance investigations to increase compliance in your organization.
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