This primer is intended to guide managers and analysts from (bio)pharmaceutical, food, chemical, environmental and other regulated laboratories through all aspects of analytical methods validation. Quality managers and staff as well as regulatory affairs professionals will also benefit through extensive discussions of relevant regulations, quality standards and guidelines. The primer will give strategies and specific recommendations for the validation of new methods that are developed internally as well as for the verification of compendial and standard methods.
In less than one day readers will get:
• An overview of regulatory and quality standard requirements
• A literature overview
• Strategies for implementation
• Information on test parameters, acceptance criteria and test conditions
• Recommendations for special applications, such as validation of bioanalytical methods, verification of compendial methods and transfer of analytical methods
The concepts and ideas expressed in this primer are my own and do not necessarily reflect official Agilent or Labcompliance policies.
Some text information and figures in this primer have been taken from Dr. Ludwig Huber’s reference book with permission from the publisher INFORMA HEALTHCARE, New York.
• L. Huber, Validation and Qualification in Analytical Laboratories, Interpharm, Informa Healthcare, New York, USA, 2007
Copyright of the text and figures resides with the publisher.
Regulations and quality standards are dynamic. They are updated every few years. Implementation guidelines, as developed by regulatory task and industry task forces, are published more frequently since state-of-the art today may not be considered as such in the future.
A timely update of all information is important and only possible using on-line information tools, such as the Internet. Therefore, I recommend the following websites with regular updates related to quality standards in laboratories:
Za odpiranje dokumenta
kliknite tukaj …