Introduction to GxP

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intro to gxp

Duration :

2

hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

Gain a recognized and traceable certificate after completing the course :Β 

All our certificates are unique, authentic, CPD/CEU accredited, and FDA 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker.

Description:

GxP guidelines are quality guidelines containing guidance and regulations for each operation in a pharmaceutical industry. The global pharmaceutical regulatory agencies and healthcare organizations like the Food and Drug Administration (FDA), World Health Organization (WHO), European Medicines Agency (EPA), and International Council for Harmonization (ICH) have standard GxP guidelines for manufacturing, testing, distribution, and documentation, etc.

This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.

 

Curriculum:

 

Lesson 1: Introduction to GxP guidelines

  • What is GxP
  • GxP vs cGxP

 

Lesson 2: The many faces of GxP

 

Lesson 3: Good Manufacturing Practice (GMP)

 

Lesson 4: Good Laboratory Practice (GLP)

 

Lesson 5: Good Distribution Practice (GDP)

 

Lesson 6: Good Clinical Practice (GCP)

 

Lesson 7: Good Documentation Practice (GDocP)

 

Conclusion

 

Glossary

 

Evaluation

Author:

marc
Marc Estrow
Marc Estrow is an Oxford University graduate from the department of pharmacology with over 20 years’ experience in drug safety & pharmacovigilance, who specializes in global safety compliance, business process improvement and signal detection. He has worked with over 50 clients in the US, France and United Kingdom. He is a featured speaker with the FDA at conferences and webinars on drug safety topics including auditing and reporting.

Reviews:

5/5
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