GXP: Industry Overview

Duration: 1 Hour and 30 Minutes

Certificate of Completion:

Provided immediately upon successful completion.

GXP: Industry Overview Description: This course provides an introduction to the drug development pipeline, the regulatory authorities that oversee the drug development process, and the standards that have been developed to ensure the safety, efficacy, and security of drugs, biological products, and medical devices. The Pipeline and Players section describes the process of identifying, developing, and testing new drugs, and the regulatory authorities that oversee the process. The GxP Regulations section discusses the standards maintained by regulatory authorities to guide laboratory testing, clinical trials, and drug manufacturing.

Accreditation: GeneEd designates this educational activity for a maximum of 1.50 AMA PRA Category 1 Credit(s)TM. Physicians should only claim credit commensurate with the extent of their participation in the activity. This credit may also be applied to the CMA Certification in Continuing Medical Education.

GeneEd, Inc. is accredited by the Institute for Medical Quality/California Medical Association (IMQ/CMA) to provide continuing medical education for physicians. GeneEd, Inc. takes responsibility for the content, quality and scientific integrity of this CME activity.

In addition to physicians, GeneEd Online Training Courses are also applicable for nurses (RNs), doctors (MD and PhDs), clinical research associates (CRAs or monitors), clinical research coordinators (CRCs), investigators, researchers, bioprocess / biomanufacturing workers, QA/QC managers, other healthcare professionals and for patient education.

GXP: Industry Overview

OUTLINEINTRODUCTION

1. Course Information

2. Interface Tour

3. Course Overview

PIPELINE AND PLAYERS

4. Objectives

5. The Drug Pipeline

6. Regulatory Overview

7. The FDA

8. EMEA

9. Japan

10. Canada

11. Progress Check

GxP REGULATIONS

12. Objectives

13. GMP

14. cGMP

15. GLP

16. GCP

17. Progress Check

CONCLUSION

18. Summary

OBJECTIVES: Students completing this course, GXP: Industry Overview, should be able to:

Describe the steps of the drug development process.

Identify the regulatory authorities in the U.S., Europe, Canada, and Japan that oversee the drug development process.

Discuss the responsibilities of the regulatory authorities in protecting public health.

Discuss the differences and similarities between the EMEA, the FDA, the MHLW, and the HPFB.

Provide the historical context behind the formation of regulatory agencies.

Define GMP, cGMP, GLP, and GCP.

Discuss the history and purpose of the GxP standards.

Discuss recent developments in international standardization of regulatory guidelines.

Describe the importance of the GxP standards in protecting public health.

Quickly access important documentation and links to FDA and EMEA regulations.

About GeneEd's Online Training:

* GeneEd Online Training Courses are high-quality, Flash driven, learning tools including voiceovers and dynamically engaging graphic animations.

* This GeneEd Online Training Course is accessible for 90 days via the Internet, and a Certificate of Completion is accessible once requirements are filled.

* GeneEd Online Training Courses have an instructional design which encourages knowledge retention and long term recollection.

* GeneEd Online Training Courses are developed for healthcare professionals (nurses and doctors), clinical researchers, and for patient education.

* To access your GeneEd Online Training Course, your username, password and login URL will be provided to you shortly after ordering.

Price: $175.00 / GBP115.50