Professionals in the field of statistical analysis need a clear and perceptive insight into how to understand and interpret statistical concepts used to investigate quantitative ICH Guidelines such as analytical methods validation, procedures and acceptance criteria in calibration limits. Along with these, process and quality controls, as well as ICH Q8 and Q9 also need to be properly and thoroughly understood.
The ICH tripartite-harmonized ICH…Continue
Added by John Robinson on May 3, 2017 at 6:18am — No Comments
It is absolutely necessary for all laboratory personnel to be aware of the current compliance issues and the ways of preventing FDA 483 and Warning Letter observations. To do so, they must:
o Be proactively alert
o Identify problem areas, and
o Implement corrective actions in order to prevent regulatory actions.
How do laboratories make this happen? Are there specific methods and procedures that they must keep in mind that will help them be…
Added by Adam Fleaming on September 28, 2016 at 6:15am — No Comments
Check out the Laboratory Safety Procedures and the new Lab Safety Document.
WASHINGTON – The Occupational Safety and Health Administration (OSHA) today published new educational materials (http://www.osha.gov/SLTC/laboratories/index.html) for…Continue
Added by Henry Wilter on October 13, 2011 at 12:53pm — No Comments
Added by Ashley Swanson on July 9, 2009 at 11:30am — No Comments