GMP for Medical Devices: EU versus FDA

5/5
11
Gmp eu vs fda

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 medical device industry has built-in quality systems which are based on Good Manufacturing Practices or GMPs. The regulatory bodies governing these systems are different in the EU and the US. In the USA, Center for Devices and Radiological Health (CDRG), FDA primarily regulates medical devices and FDA itself conducts all regulatory inspections. The US FDA has also laid down GMP compliance requirements for development, manufacturing, and distribution of medical devices in the Code of Federal Regulations: 21 CFR, Part 820.

In this course, we provide a comparative synthesis of the topic through an interactive online experience. It applies to all areas of GMP for Medical Devices and provides adequate training with regards to quality management and GMP compliance in the medical device manufacturing industry. 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: Differences Between EU and FDA GMP Requirements

  • European main requirements
  • FDA main requirements
  • Difference
  • Similarities

 

Lesson 2: GMP-Related Requirements of EN ISO 13485 : 2016

 

Lesson 3: FDA’s GMP Requirements in 21 CFR Part 820

 

Lesson 4: Design Controls of Medical Devices

  • How to Implement Design Controls in Life Cycle Process

 

Lesson 5: Process validation

 

Lesson 6: Complaint handling (Corrective and Preventive Action)

 

Glossary

 

Evaluation

Author:

patricia kay
Dr. Patricia Kay
Dr. Patricia Kay is a results focused senior research management professional with over 20 years experience in the life sciences. She has a significant expertise in clinical development, health program management, strategic planning, stakeholder management, business unit operations and personnel management. Dr. Kay has a broad knowledge of cardiovascular disease, immunology, infectious diseases. She worked as Clinical Research Associate at Pfizer, GSK, AstraZeneca and she takes part in many startups boards in Europe and USA.

Reviews:

5/5
11
USD: United States (US) dollar ($)

$60

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