The Analytical Pharma Organization: Going Beyond Pockets of Activity _________________________________________________________
The topic of analytics as a performance lever for continuous improvement seems both obvious and odd. Anyone who has been involved in operational excellence, Lean manufacturing, Six Sigma, Kepner-Tregoe, or other problem-solving techniques knows the value of measurement as a tool for improvement. Yet, analytics is much more than just measuring and reporting data. The concept of using analytics as a catalyst for business improvement involves transforming an organization's decision-making process and offers a foundation for business strategy and tactics.
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Who Owns the Quality System? Everybody, Somebody, or Nobody? _________________________________________________________
On a philosophical level, everyone owns "quality." Much like safety, everyone has responsibility for following safe practices and calling attention to potentially unsafe conditions. But in this case it is necessary break away from generalities and get very specific, because it is often in the specifics where QMS falls apart in practice. It has to do with the notion of "ownership" and having a person-by name-for each element of the QMS who "owns" that particular element and exhibits defined "ownership behavior."
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In this webinar, senior consultant Chris Tsai shares a client case study illustrating how the problem solving process can create a paradigm shift in an organization's quality system.
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Quality Risk Management: 16 FAQs to Chew On _________________________________________________________
After two years of receiving input from industry regarding EU quality risk management regulations and practices, U.K.'s MHRA has just posted a list of 16 Frequently Asked Questions about QRM that industry should mull over. Among them are the following.
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Frightening Phrases and Warning Letter Language to Watch _________________________________________________________
There's no doubt that the FDA is flexing its enforcement muscle these days. That's apparent in its talk about executive prosecutions, and in recent consent decrees. And to back up its "we mean business" posture, the FDA has tightened inspection-to-warning time, halved the time allowed for manufacturers to respond to warnings, and taken a pass on legal reviews prior to sending warning letters.
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Registration is Open! 2-day Workshops on CAPA and Documentation __________________________________________
Is your company ready for an FDA audit? Do you need assistance correcting and preventing non-conformances or conducting a root cause analysis? Or how to write an effective investigation report? PathWise public training workshops can help.
This coming year, we are pleased to offer a suite of Documenting Investigations and Corrective and Preventive Action quality training workshops, located across the globe to fit any schedule or budget.
View events in your area.
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Monthly Newsletter
PathWise, Inc.
December 2010 |
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Upcoming Events
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.
February 16-17, 2011
Orlando, FL
March 23-24, 2011
Salt Lake City, UT
August 3-4, 2011
Boston, MA
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.
_________________ 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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