New Report: A Status of Quality in Life Sciences _________________________________________________________
Every quarter, our team at PathWise issues a new survey polling 25,000 quality professionals in the life science industry. Covering issues from CAPA to Risk Management, our survey responses provide an inside look into how quality departments and budgets are allocated and how life science organizations are currently managing their quality systems.
As a special thank you to our valued readership, we've compiled our 2011 quality survey results into a downloadable report. We hope you find this information of benefit for your quality system management efforts into 2012 and beyond.
Best wishes for a compliant, effective and efficient new year!
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Biopharma Automation: Transformation
Through Training
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Biopharmaceutical manufacturing is poised to enter a more efficient and robust phase. New technologies, particularly in the area of automation, are enabling operations that are faster and better understood than in the
past. If biomanufacturers are to keep up with, and leverage, technological advances, they must provide effective training for their key
personnel.
This special PDF-with additional links to web-based resources-looks at the importance of automation technical training and how it can provide biopharma manufacturers with clear competitive advantages. Download the report. |
Medical Devices to Watch in 2012
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The year 2012 might see the much-hyped therapies of stem cells and gene therapy become clinical realities. Data showing that heart-derived stem cells improved the cardiac output of heart failure patients with myocardial infarction seemed to be a true breakthrough.
Check out some of the most promising and innovative new medical devices to track in 2012
Read complete article.
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ICH Q11 Guidance Nears Final Approval After Comments Prompt Changes
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The final version of ICH's drug substance development and manufacturing guideline Q11 is nearing Step 4 clearance by the regulatory agencies in the three ICH regions following some significant changes the Expert Working Group (EWG) has made to the Step 2 draft based on the comments received.
Read complete article. |
Proposed boost to FDA's budget could turn the heat down on user fee negotiations
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FDA negotiations with the medical device industry over user fees may get a little relief if a bill granting the watchdog agency a boost to its 2012 budget gets the green light from Congress.
As part of a bill from a House/Senate conference negotiation last month, the FDA's pocketbook would not only avoid getting a trim - the agency would get a $50 million boost over last year's budget.
Read complete article. |
FDA Seeks Input on Device Classification System
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Recently, the Food and Drug Administration (FDA) opened up a public comment period, extending to mid-January, to get perspective on whether the information gathered during reclassification submissions of medical devices is necessary and useful, whether it's gauge on timing and burden is appropriate, and how to improve on the process and minimize burden.
According to an article from MassDevice, FDA "is also looking for ideas on how to use automated collection techniques and other forms of information technology to make the submission process easier."
Read complete article. |
Poll: Do you include employee names or employee titles in your investigation reports?
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When conducting and documenting quality investigations, the inclusion of specific employee names is often up for debate. Do you include employee names or employee titles in your investigation reports?
Take the poll. |
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Monthly Newsletter
PathWise, Inc.
December 2011 |
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Upcoming Events
CAPA 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.
Feb. 15-16, 2012
Switzerland
_________________ 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.
March 15-16, 2012
Chicago, IL
June 14-15, 2012
Boston, MA
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PathWise Webinars
Integrating FDA and Trending
Requirements into your CAPA System
This session offers attendees a how-to approach to effectively integrate the FDAs CAPA and trending requirements, providing them with the skills and tools necessary to develop a strong, sustainable and compliant CAPA System.
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Best Practices to Manage an FDA Inspection
When it comes to quality system audits, the level of preparation within your organization can make a significant difference in your level of success. This webinar discusses how to effectively prepare for and manage an FDA inspection.
Download webinars.
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