The aim of this one day course is to understand what can be defined as raw data and explore the meaning of the term for manufacturing, laboratory and quality records. Is there harmonisation of US and EU GMP regulations? For example,
What is a “quality decision” and what is the impact of having to define raw data for the process or system?
Can raw data be equivalent to complete information and complete data?
Should we treat manufacturing “information” and laboratory “data” as the same?
For more information visit www.gmp-compliance.org