The costs related to USP 797 compliance can vary greatly. Your specific needs will depend on your current compounding environment, as well as the types of CSPs being prepared. A key consideration, however, is the cost of non-compliance in the event that a contamination is tracked to your facility.
A recent survey of North American employees found that 87 percent of respondents say their work/life balance is negatively affecting their health. If you’ve been killing yourself trying to achieve daily work/life balance, it may be a pipe dream.
Google can find targeted content in articles, books, and other material. I use it every day to answer specific questions, and to find specific references and information.
An art exhibit in London inspired us to ponder changing views about the definitions and implications of soil, residue, contamination, and especially the design and operation of controlled environments.
The FDA guidance on process validation issued in January 2011 has turned the quality and product development worlds upside down.
How do I best establish an Equipment Reliability (ER) program?
Wet dust filters not only ensure regulatory compliance but can also improve worker comfort and production flow.
More than just surface-clean.
Determining the right glovebox for the right level of containment.
The Green House Gas (GHG) audit industry is relatively new, and many are clamoring to enter this market before it becomes too costly to do so.
We’ve all been there. A team member comes up to you with a “great idea.” Sometimes the idea is good, but maybe not great. Sometimes the idea has little merit. In his blog, “Radical Management,” Steve Denning offers advice on how to respond in these situations without deflating the energies and passion of your team.
Planning and pre-testing are keys to successful validation. Validation of a critical or precision cleaning process is a good idea whether or not there are specific regulatory requirements to do so. A validated cleaning and contamination control process is important in placing you above the competition.
In the disc drive, microelectronics, and semiconductor industries, static electricity can cause immediate or latent failure of the product. It is imperative to control static electricity in cleanrooms and controlled environments.
All you have to do is look around your organization to see the impact this economic storm has had on the workplace. Now it’s time to focus on the process of rebuilding loyalty and employee engagement.
The suggestion is often heard in troubleshooting or, proactively, in validating critical cleaning processes.