Article Download: "Standard Work" for Problem Solving
_______________________________________________________
When problems occur, are they addressed in a planned, consistent, predictable way? Does a simple problem receive the same level of rigor as a complex problem? Are the appropriate problem solving resources involved and do they all have a consistent expectation of roles and responsibilities?
This article outlines many of the roadblocks in quality system problem solving and how to overcome them.
Download article. |
ICH Q11 Guideline Structure and Content Taking Shape _______________________________________________
The structure and content of ICH Q11 on drug substance development and manufacturing is taking shape as the Expert Working Group (EWG) resolves the challenging issues around the guideline's breadth and depth and its relationship to the other guidelines in the ICH quality family.
Under the current structure emerging out of the EWG discussions at its June meeting in Tallinn, Estonia, the guideline will contain sections on: manufacturing process development, description of the manufacturing process, starting materials, control strategy, process validation/evaluation and process lifecycle management. . Read complete article. |
Redefining Risk Management in the Supply Chain __________________________________________
The recent economic challenges have led many companies to revisit their view of risk management. Among other areas of risk, many had to rethink their approach to low-cost country sourcing. By the end of 2008, many executives and their sourcing organizations were chagrined to discover that the lowest-cost country was no longer Mexico, Poland or the Philippines. It was actually the United States.
As a result, it became increasingly clear that risk is not just lurking in the dark corners of a supplier's four walls. Nor is it limited to the traditional issues of quality, delivery and cost.
|
_______________________________________________
The federal transparency campaign is reshaping drug research, production, regulation, and marketing on multiple fronts. The US Food and Drug Administration and the National Institutes of Health (NIH) are requiring more disclosure about the financial relationships between pharmaceutical companies and the scientists who conduct biomedical research and serve on government advisory committees.
Read complete article. |
Where does your organization manufacture it's products?
________________________________________________________
The impact of the global recession and the increasing need for cost cutting measures has forced many organizations to rethink where they are manufacturing their products.
Where does your organization manufacture it's products?
|
Last Month's Poll Results: Communication and Teamwork Top List for Improvement in Quality Teams
_________________________________________________________
Last month, we issued a poll asking "What aspect of your quality team needs the most improvement?"
Here are the results from the life science manufacturers worldwide:
#1 Communication and Teamwork
#2 Resources and Budget
#3 Systems and Processes
|
|
|
|
|
|
|
|
Monthly Newsletter
PathWise, Inc.
July 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.
September 15-16, 2010
Newport Beach, 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.
_________________
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.
|
|
