Quality Risk Management

4.5/5
18
Quality Risk Management

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:

Risk management has a strong role as a precautionary tool for the regulation of pharmaceutical and biopharmaceutical products. Preventing healthcare hazards from happening in the first place requires approaches to minimize risk to patient safety and health proactively, rather than reactively. This is where Quality Risk Management (QRM) comes in.

In the following lessons:

  • We will discuss Quality Risk Management principles and their practical application in the pharmaceutical industry, which will aid in the development and production of high-quality medicinal goods.
  • We will explain Quality Risk Management (QRM) models and processes that can be applied to various aspects of pharmaceutical quality.
  • Finally, we’ve included a short quiz at the end of the course to test your knowledge and understanding of the course.

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

 

  • Why is quality risk management needed
  • Formal and Informal Risk Management Processes

 

Lesson 1: Principles of Quality Risk Management

 

  • Primay principles
  • Secondary principles

 

Lesson 2: Quality Risk Management Process

 

  • Risk assessment
  • Risk control
  • Risk communication
  • Risk review

 

Lesson 3: Managing Risks – Quality Risk Management Methodology

 

Lesson 4: Application of Quality Risk Management in the Pharmaceutical Industry

 

  • Commercial Manufacturing
  • Product development

 

Lesson 5: Role of Quality Risk Management in Regulatory Affairs

 

 

Conclusion

 

Glossary

 

Quiz

Author:

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:

4.5/5
18
USD: United States (US) dollar ($)

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