Risk Analysis Model for Management of Quality Risk

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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:

The pharmaceutical industry relies on limits that have been predetermined through research to evaluate the quality of products, raw materials, and by-products at every phase of the manufacturing process. This course introduces you to the concept of Quality Risk Management (QRM) which must be applied all through the manufacturing process, even at the level of raw material suppliers to ensure that the final pharmaceutical products and devices are safe and effective for patients’ use. Risk analysis is a necessary component of QRM as it unearths hidden issues in the manufacturing process.

 

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

 

  • Background and Scope
  • Quality Risk Management (QRM)
  • Aim of the Quality Risk Management (QRM) to the Pharmaceutical Industry
  • Principles of Quality Risk Management

 

Lesson 1: Purpose of Quality Risk Management (QRM)

 

  • Quality Target Product Profile (QTPP)
  • Finished Pharmaceutical Product (FPP)
  • Critical Process Parameters (CPPs)
  • Critical Quality Attributes (CQAs)

 

Lesson 2: Quality of Risk Management Process

 

  • Personnel Involved in QRM
  • Product and Process Knowledge
  • Risk Assessment
  • Maintenance of Risk Assessment Records
  • Risk Control
  • Risk Review
  • Verification of Quality Risk Management Process and Techniques
  • Communication and Documentation of Risks

 

Lesson 3: Pharmaceutical Applications of QRM

 

  • Responsibilities
  • QRM Application During Product Development
  • Use of QRM in Commercial Manufacturing
  • Integrating QRM with Critical Components of the Quality System
  • Application of QRM in Product Manufacture

 

Lesson 4: QRM Considerations for Medicines Regulatory Authorities

 

  • QRM Application to Inspection Strategy

 

Lesson 5: Risk Management Tools

 

Lesson 6: Project Risk Analysis and Management (PRAM)

 

  • Qualitative Risk Analysis
  • Quantitative Risk Analysis
  • Benefits of PRAM

 

Conclusion

 

Glossary

 

Quiz

Author:

Bashir
Dr. Masaab Bashir
Dr. Massab Bashir holds a Ph.D. in Microbiology and Immunology. Dr. Bashir leads a medical and research writing team of qualified doctors. Massab and his team have over five years of research writing experience in the medical, biotech, and pharmaceutical fields. To date, Dr. Bashir and his team have successfully completed more than 500 projects

Reviews:

5/5
47
USD: United States (US) dollar ($)

$48.00 $60

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This course includes:
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Updated content every month
Certificate of completion

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