In this 1-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.
Attend this 1-hr presentation webinar with your team to understand the pitfalls and risks of having GMP and GLP practices occurring in one location and strengthen the understanding of the lifecycle of a method or procedure.
Why Should You Attend:
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.Attend this 1-hr presentation webinar with your team to understand the pitfalls and risks of having GMP and GLP practices occurring in one location and strengthen the understanding of the lifecycle of a method or procedure.
Areas Covered in the Webinar:
- CFR guidance for GMP testing of pharmaceutical products.
- CFR guidance for GLP practices and method and procedure development.
- Product testing and regulatory requirements.
- The transition from a procedure in development to one used routinely.
- The use of test plans.
- Establishing boundaries.
Who Will Benefit:
This webinar will provide valuable assistance to all personnel in:- QC functions in general
- QC technical transfer groups
- QC validation groups
- Commercial testing facilities
- Product development
- QA reviewers who are responsible for both GMP and GLP documentation practices
Course Provider
Barbara Berglund,
