Good Laboratory Practices (GLPs) comparing and contrasting GMPs

Course Objective:

The objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing practices.

Reasons To Attend:

Good Laboratory Practices (GLPs), CFR part 58, are a set of guidelines for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products such as food and color additives, human and animal drugs, medical devices for human use, biological products and electronic products that are regulated by the FDA.

GLPs are not enforceable by law. They do not include manufacturing of product. GLPS are for non-clinical laboratory studies in which tests article are studied in test system under laboratory conditions to determine their safety. This does not include studies utilizing human subjects, or clinical studies, or field trials on animals.

Areas Covered:

GLP: Good Laboratory Practice
GLP is an FDA Regulation
Definition of GLPs
History of GLPs
Why was GLP Created?
Objectives of GLP
Mission of GLP
Instrumentation Validation
Analyst Certification
Laboratory Certification
Grounds for Disqualification
Consequences of Noncompliance
Reinstatement of a Disqualified Facility
Refrences

Learning Objectives:

What are Good Laboratory Practices
Why were they created
What is the objective of GLPs and how are they associated with GMPs and SOPs
Statistical procedures for data evaluation
Instrumentation validation
Analytical and laboratory certification
Documentation and maintenance of records
Consequences of noncompliance
Disqualification and reinstatement

Target Audience:

Quality Assurance Personnel
Quality Control Personnel
Research and Development Personnel
Regulatory Affairs Personnel
Project Managers
Manufacturing Managers
Validation Engineers
Internal Auditing Personnel
Microbiology Personnel
Auditors