COURSE ID 2564

GLP and Quality Assurance

Developing a GLP Compliant QA Program

AVAILABLE ON-DEMAND
Duration: 8 Hours
Course Instructor

David Long

Price
$ 1300
Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

View Course Outline

Benjamin Franklin famously said:
“Tell me and I forget; teach me and I may remember; involve me and I learn.”

This course has been designed with this cogent observation in mind so that each person can get involved in problem-solving and thus learn about how to perform the role of Quality Assurance for laboratories undertaking studies that must be performed in compliance with Good Laboratory Practice (GLP) Regulations.

Overall, the main intent is to review the roles and responsibilities of the QUALITY ASSURANCE (QA) group auditing and inspecting GLP studies. The important responsibility of setting up, maintaining, and performing a QA program in a laboratory is at the core of this course. The learning initiative is achieved through short lectures, illustrative answers to FAQs, and problem-solving workshops. The aim is to ensure that each participant is personally faced with real-life situations for which a member of a GLP/QA team must find GLP-compliant solutions.

To be efficient in GLP /QA you must understand how studies are planned, performed, and reported, and how a general GLP environment can be assured in the laboratory. Thus, we put great importance on the establishment and application of a GLP/QA audit and inspection program. The participants will also be challenged with the issues of study integrity, the problems of study reconstruction, and the establishment of valid operating procedures.

Involving the participants in GLP decision-making processes means that they will learn and understand rather than just receive information as they would from a standard course.

This accredited training, will concentrate on existing OECD and FDA Good Laboratory Practices and their application to the workplace including recent developments such as multi-site studies.

Upon completion of this course, you will be able to:

  • Effectively implement and maintain a GLP Quality Assurance function in your institution based on acceptable rationale
  • Perform inspections and audits of all on‐going GLP activities
  • Undertake the role of Lead QA in a multi‐site situation
  • Set up and maintain a QA program
  • Perform report reviews using different techniques
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The participants in this course will already know the basics of Good Laboratory Practice either through prior experience or completion of Good Laboratory Practices (GLP) (Course id #545)

The course is designed for those who wish to master how to implement and maintain a GLP QA function. The course explores quality issues within preclinical GLP and provides an opportunity for experienced personnel to update their competencies. Participants may come from:

  • Life-Science Industries
  • Academia
  • Government
  • Contract Testing Facilities

The course is designed for people who are considering a career opportunity in GLP/QA or those who are already GLP/QA personnel but who wish to refresh or perfect their QA knowledge and skills.

Course Instructor

David Long

Long and Associates International Consulting Ltd.

David Long’s Courses

Accreditation

Team Training

When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.

Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.

In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.

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