Complimentary Download : CAPA System Implementation Map
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The FDA reports that a leading cause of observations and warning letter issuance is deficiency within the CAPA system. Many organizations struggle with CAPA, unable to differentiate ongoing procedures from the entire system.
CAPA is not just a procedure - it is your company's immune system. It is the system by which your company detects problems, finds root cause and implements corrective or preventive actions to prevent reocurrence.
Learn how to implement a corrective / preventive action system using our CAPA System Implementation Map.
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Change Filing Requirements Present Continuous Improvement Roadblocks for Pharma
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The power of the advancing pharmaceutical quality systems to manage change and drive continuous improvement is being hampered by the disharmony and inflexibility of the CMC filing requirements across the globe, prominent industry and regulatory experts reemphasized at a quality systems/ICH Q10 conference in Arlington, Virginia earlier this month.
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Report: More Than 75% of MedTech Companies Go Overseas First
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High costs, long review times and increasing unpredictability led more than three-quarters of medical device makers to seek overseas regulatory approval before launching a bid for FDA clearance, according to the largest-ever survey on the 510(k) review process.
Read complete article.
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FDA Forms Expert Panel to Speed Up Device Approval _________________________________________________________
The U.S. health regulator said it is seeking public input on a plan to create a network of outside experts who would help understand new technology in medical devices, potentially speeding up device approval.
The Food and Drug Administration has formed a pilot committee of such experts, which will run through Dec. 30 and expand the pool of vetted sources the agency already has.
Read complete article. |
Pharma Purchasing and Outsourcing Approach Needs Overhauling, Supply Chain Expert Asserts
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Regulatory pressure and "true cost" understanding will push pharmaceutical firms to reverse the current outsourcing trend and gain back more control of their critical ingredients and components, supply chain expert Andrew Cox asserts.
Supply chains in the pharma industry are "very different" from other industries and have "unique problems," he stressed. These problems are compounded by a lack of realism around outsourcing, reflecting the manner in which purchasing decisions are made and who is involved in those decisions.
Read complete article. |
Are FDA Process and Taxes Spurring Exodus of Medical Device Firms?
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Trends show clinical trials shifting to Europe, where the review process is quicker. In addition to a lengthy and cumbersome approval process, U.S. medical device companies face other obstacles. A huge one is a 2.3% excise tax on the medical device industry, which is part of the new health care law; scheduled to take effect in 2013.
Read complete article. |
FDA Announces Training Program to Improve Medical Device Reviews _________________________________________________________
The U.S. Food and Drug Administration (FDA) just announced two training programs it will be implementing that are intended to improve how medical device reviews are conducted.
The training will improve review consistency and will help improve the skills of the reviewers looking at premarket applications at the Center for Devices and Radiological Health (CDRH).
Read complete article. |
Are Your Documentation Practices Up to Code?_________________________________________________________
World regulatory bodies state "If it's not written down, it didn't happen."
Too often in organizations, thorough investigations are performed only to let poor documentation practices create issues and rework. Why not take the necessary steps to get credit for all of your hard work?
Our one day Documenting Investigations course teaches proven technical writing techniques and tools that will meet regulatory expectations.
Learn more. |
Poll : Over 2/3 of Life Science Orgs Do Not Employ a Full-Time Quality Investigator
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Understanding how to conduct a thorough, timely, well-documented and scientifically defensible investigation is a key requirement for any organization operating in a regulated industry.
Last month we issued a poll to over 20,000 life science professionals asking "Does your company employ a full-time quality investigator?"
Here are the results:
37.5% - Yes
62.5% - No
Get expert advice on quality system investigations. |
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Monthly Newsletter
PathWise, Inc.
October 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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Documenting Investigations
These one day courses teach proven technical writing techniques and tools that will meet regulatory expectations.
December 8, 2011
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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.
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Conducting OOS and Non-Conformance Investigations
Attendees will learn how to effectively expedite and document OOS and non-conformance investigations to increase compliance in their organizations.
Download webinars.
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