Hot off the Press! Former FDA Investigator to Present at PathWise CAPA Workshop-__________________________________________________
PathWise is pleased to welcome former FDA Investigator and content expert, Dannie Rowland, to their upcoming CAPA Workshop to be held in Newport Beach, California.
Rowland will host a general session covering topics such as common regulatory struggles faced by manufacturers and best practices for Quality System improvements.
Read the press release.
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Medical device manufacturers face an array of challenges in delivering products to international markets. Complying with diverse and evolving regulatory requirements that vary by country, providing country-specific translations, and ensuring compliance and consistency throughout the global supply chain are critical to successful labeling, documentation, and packaging processes.
This article will address the challenges in delivering product to global markets, and provide best practices for success.
Download the article. |
Design Thinking vs. Six Sigma: Welcoming the New, Improving the Old
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For decades, companies from Cisco Systems to Staples to Bank of America have worked to embed the basic techniques of Six Sigma, the business approach that relies on measurement and analysis to make operations as efficient as possible.
More recently, in the last 5 to 10 years, they have been told they must master a new set of skills known as "design thinking." Aiming to help companies innovate, design thinking starts with an intense focus on understanding real problems customers face in their day-to-day lives.
Read the full article. |
Community Poll: What is the biggest challenge in locating the root cause of a CAPA?
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Getting burned by fire fighting? Too often expensive problems are never resolved and reoccur because of the difficulty in locating the root cause.
What is your biggest challenge in locating the root cause of a CAPA? Vote now. |
New Warning Letter "Closeout" Program from the FDA
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Beginning this month, the FDA may now issue a Warning Letter close-out letter once the Agency has completed an evaluation of corrective actions undertaken by a firm in response to a Warning Letter.
A close-out letter may issue when, based on FDA's evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter. This procedure applies to Warning Letters issued on or after September 1, 2009.
Read the program announcement. |
Join PathWise on Facebook
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Come visit our new fan page on Facebook, where you'll find the latest news & events that PathWise has to offer.
Visit our fan page. | |
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Monthly Newsletter
PathWise, Inc.
September 2009 |
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.
For more information or to purchase.
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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