GMP for clinical trials manufacture and supply

5/5
8
GMP clinical trials

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 : 

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:

As much as GMP is important for drugs that are approved to market by the FDA/EMA, it is equally pivotal for investigational medicinal products that are still undergoing clinical trials. Understanding and applying current GMP requirements to practice while manufacturing clinical trial material ensures that the investigational drugs and medicinal products are consistently produced under stringent quality control activities.

In this course, we provide a synthesis of the topic through an interactive online experience. 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:

 

Introduction

 

Lesson 1: Quality Management of IMPs

 

Lesson 2: Quality Risk Management

 

Lesson 3: Personnel Management

 

Lesson 4: Documentation of IMPs

  • Manufacturing Formulae & Packaging Instructions
  • Labeling Instructions
  • Batch Manufacturing Records
  • Coding Systems

 

Lesson 6: Production for Clinical Trials Manufacture

  • Manufacturing operations
  • Packaging and Labeling
  • Blinding

 

Lesson 7: Qualification and validation

 

Lesson 8: Recalls and market returns

 

Lesson 8: Shipping

 

Lesson 9: Destruction

 

Glossary

 

Conclusion

 

Evaluation

Author:

image
Dr. Ciaran McEnister
Senior Pharmaceutical Executive with 25+ years of experience in medical device development. Translational Research, Pharmaceutical development, Pharmacologic/Toxicologic and Preclinical research and Regulatory compliance of small and large molecule drug candidates. Dr. McEnister has an extended experience as senior quality manager at Merckx, BioDevices and IPSEN.

Reviews:

5/5
8
USD: United States (US) dollar ($)

$60

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This course includes:
Full lifetime access
Updated content every month
Certificate of completion

GxP-Training Benefits

$60.00

$60.00

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