Laboratory Compliance 2012 - Does your pharmaceutical lab have GMP and non-GMP functions?

In this 2-hr webinar you will learn how to differentiate and draw boundaries for GMP and GLP practices if done in same laboratory and how to transition a procedure in development to one used routinely.

If a laboratory is dedicated either to GMP testing and validation activities or to method and procedure development and validation, then the laboratory is responsible for following the appropriate CFRs. GMP guidance’s for the pharmaceutical industry are included in 21 CFR, and for GLP guidance’s can be found in 58 CFR. However, if both types of work are being done in the same laboratory and even by the same analysts, it is critical to define boundaries. This involves not only the analysts and the laboratory management but extends to reviewers of critical documents and client education regarding the practices and policies.