Validation and qualification for analytical methods and equipment are required by many regulations, quality standards and company policies. If executed correctly, they can also help to improve the reliability, consistency and accuracy of analytical data. This course guides analyst, laboratory managers and quality assurance managers through the validation and qualification processes in analytical laboratories.
The course takes into account most national and international regulations and quality standards. Participants of this course will learn how to speed up their validation and qualification process, thereby avoiding troublesome reworking and gaining confidence for audits and inspections.
The validation and qualification procedures presented in this course help to ensure compliance and quality but with minimal extra cost and administrative complexity. The purpose of this course is to answer the key question regarding validation: How much validation is needed and how much is sufficient? The recommendations are complementary rather than contradictory to any standards or official guidelines. They are based mainly on common sense and can be used in cases where information from official guidelines and standards is insufficient for day-to-day work.