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Saturday, March 23, 2019
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GXP: Industry Overview (GXPOV)

Certification Training
Duration: 1.8 hours, Online (the average time to complete the training program, including final assessments).
Credits Hours: 2
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

THIS COURSE IS CURRENTLY NOT AVAILABLE.
Contact the BioPharma Institute for more information.

BioPharma Institute LogoTraining Program: GXP: Industry Overview
Training Provided By: BioPharma Institute
Website: https://www.biopharmainstitute.com

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment. BioPharma Institute ReviewsThis 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.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with >80% passing grade within a 90 day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.

The GXP: Industry Overview course is found in the following professional certification program(s):


COURSE OUTLINE:


INTRODUCTION
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

COURSE OBJECTIVES:


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.

Online Training Program Benefits:

  • Immediate access to training: Instructions, username, password and receipt of payment emailed instantly upon online enrollment
  • Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter
  • Self-paced courses: 24/7 access to individual courses for 90 days; and 180 days for professional certification programs
  • Flexible final assessments: Tests include multiple-choice questions and can be taken repeatedly until a passing score is achieved
  • Direct access to certificates: Documentation instantly available once course requirements have been fulfilled
  • Verification of training: Certificates can be verified online, and electronic badges are issued for all Professional Certification programs
  • Corporate reimbursements: Employers may pay for or reimburse employees for training. Purchase orders (POs) for both individual and group training are accepted
  • Corporate LMS solutions: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems
  • Secure and safe access: Website and LMS offer an encrypted connection with firewall protection and daily scans for optimal level of security and performance
  • Career advancement: Professional certifications may be helpful for those seeking new careers or transitioning to different positions within their organization

For more information on the BioPharma Institute's training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370, or email Support@BioPharmaInstitute.com.

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