Whitepaper Download: The Secrets of Team Facilitation
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More and more businesses are turning to work teams to improve their products, processes and services-- and for good reason. When work teams work well, they are more likely to produce creative breakthroughs and practical solutions than when employees labor alone.
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CDER Stresses Need for Better Supply Chain Risk Management
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Willing parties, quality agreements and information from suppliers are all needed along with auditing programs in managing pharmaceutical supply chain risks, CDER Office of Compliance Division of Manufacturing and Product Quality (DMPQ) Director Richard Friedman stressed in addressing industry/regulator initiatives to strengthen supply chain integrity.
In managing risk, FDA understands that qualification is not going to be at the same rigor for each supplier, Friedman explained.
Read complete article. |
Medical Device Industry Pushes for Better Guidance __________________________________________
A recent commitment the FDA made in exchange for receiving user fees from industry was to expedite its production of guidance documents to provide industry with a "roadmap" of how to bring a product from development to clearance for sale.
"Having that roadmap, that document that says that from FDA's perspective, here's what we need, that gives us a lot of certainty and predictability, which are two of the things that our companies care about most," noted Medical Imaging and Technology Alliance executive director David Fisher.
Read complete article. |
Poll Results: The quality of CAPA investigations and documentation varies between countries, markets, and/or cultures
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Last month, we issued a poll asking "Does the quality of CAPA investigations and documentation vary between countries, markets, and/or cultures?"
A 100% unanomous majority of respondants claimed yes. Some of the top comments include:
"It all comes down to basic knowledge of how to run a process. Advanced countries are likely less able to do effective CAPA due to politics and financial pressure. Lesser developed countries are still able to use common sense."
"CAPA is very much a US-FDA concept."
"The more importance a BOH places on this activity, the deeper an investigation will tend to delve and the more rigorous will be the CAPA."
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Corrective and Preventive Action: Upcoming Workshop in San Francisco
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Our two day course is designed to meet the requirements mandated by the FDA to effectively investigate and locate causes and correct them.
Join us October 27-28 as we show you how to identify non-conformances (problems), how to assess and prioritize them based on risk, and how to implement a proper corrective and/or preventive action.
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Monthly Newsletter
PathWise, Inc.
September 2010 |
CAPA Workshops for Life Sciences
This 2-day course, taught by former FDA Investigators, PathWise, and MasterControl industry experts, is designed to meet the requirements mandated by regulatory agencies to effectively investigate and locate causes and correct them.
October 27-28, 2010
San Francisco, CA
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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