Don't be afraid of macros - learn how to create and use them. When you find yourself repeating actions in Excel - whether it's a five-step sequence you use when formatting a certain cell type or the 30 steps you use when you sort, filter, and print multiple worksheets once a week, the possibility exists that you can automate these actions in the form of a macro. Thereafter, you can perform these sets of actions with a simple keystroke combination, a button in a worksheet, or by using a button in the Quick Access toolbar.
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented.Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.
This 3-hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to GMP requirements.
This webinar will take a closer look fire loss from an environmental prospective. We will discuss both wildfire and structural fire claims and discuss the different approaches for each type of loss. We will look at the differences between a wildfire and structural fire chemistry and difference forms of combustion by-products produced by each.
In December 2010 FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, it has now turned into an ongoing program with Part 11 related issues being part of most future inspections. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003. In the meantime FDA officials reported about key findings. For example, George Smith who heads up FDA's Part 11 working group gave an update with examples of violations.
True RBIA incorporates cascading the process through to each individual audit as well as the audit reporting process. The training program will focus on the establishment of a framework or methodology for RBIA and examine how to utilize risk-based questions within the process steps.
This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11.This will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome.