100%
Dark site-logo
  • Home
  • eLearning Courses
    • All Courses
      • View All Courses
      • Medical Device Courses
      • Pharma/Biopharma Courses
      • Combination Product Courses
      • Problem Solving Courses
    • Sectors
      • Staff Training Needs
      • Training for MedTech Manufacturing Startups
      • Drug/Device Combination Products
      • Upskill/Reskill for work in MedTech
  • In-Company Training
    • Medical Devices
      • Medical Device Micro-Training Courses
      • Quality Systems
        • ISO 13485:2016 Clause by Clause
        • Introduction to 21 CFR 820 Quality System
      • CAPA
        • CAPA in the Medical Device Industry
        • Project Management Skills for an Effective CAPA
      • Audit preparation
        • How to Prepare for a FDA QSIT Inspection
        • How to Prepare for a Medical Device Single Audit Program (MDSAP)
    • Combination Products
      • Annual cGMP Drug/Device Combination Products (21 CFR 820, ISO 13485:2016, CFR Part 4, 210 and 211)
    • Pharma/Biopharma
      • Pharma/Biopharma Industries Micro-Training Courses
      • CGMP Essentials for the Pharma/Biopharma industry
    • Quality Management
      • Quality Management Systems
        • ISO 9001:2015 Clause by Clause Classroom Training
      • Quality Culture
        • Creating a Quality Culture
      • Problem Solving
        • A3 Problem Solving Training Course
    • Food Safety Management
      • Introduction to HACCP Classroom Training
      • ISO 22000 Clause by Clause Classroom Training
    • Soft Skills
      • Effective Meeting Skills Classroom Training
    • Lean Management
      • 5S Training Course
      • Mistake Proofing (Poka Yoke) Training
    • Core Tools
      • Failure Mode and Effect Analysis (FMEA)
      • Effective Technical Writing Skills
  • Virtual Training
    • Medical Devices
      • Internal Auditor ISO 13485:2016 Training Course
      • Introduction to CAPA for Medical Devices Training Course
      • Introduction to ISO 13485:2016 Training Course
      • EU Medical Device Regulation (MDR) 2017/745 Fundamentals Training Course
    • Quality Management Systems
      • Internal Auditor ISO 9001:2015 Training Course
      • Introduction to ISO 9001:2015 Training Course
    • Food Safety Management (HACCP)
      • HACCP Food Safety Management Fundamentals Training Course
  • Resources
    • Blog
    • Glossary
    • FREE Micro-Learning Videos
    • Useful Links
  • FAQ
    • eLearning FAQ
  • About us
  • Contact Us
Login
  • Home
  • eLearning Courses
  • In-Company Training
  • Virtual Training
  • Resources
  • FAQ
  • About us
  • Contact Us
  • All Courses
  • Sectors
  • View All Courses
  • Medical Device Courses
  • Pharma/Biopharma Courses
  • Combination Product Courses
  • Problem Solving Courses
  • Staff Training Needs
  • Training for MedTech Manufacturing Startups
  • Drug/Device Combination Products
  • Upskill/Reskill for work in MedTech
  • Medical Devices
  • Combination Products
  • Pharma/Biopharma
  • Quality Management
  • Food Safety Management
  • Soft Skills
  • Lean Management
  • Core Tools
  • Medical Device Micro-Training Courses
  • Quality Systems
  • CAPA
  • Audit preparation
  • ISO 13485:2016 Clause by Clause
  • Introduction to 21 CFR 820 Quality System
  • CAPA in the Medical Device Industry
  • Project Management Skills for an Effective CAPA
  • How to Prepare for a FDA QSIT Inspection
  • How to Prepare for a Medical Device Single Audit Program (MDSAP)
  • Annual cGMP Drug/Device Combination Products (21 CFR 820, ISO 13485:2016, CFR Part 4, 210 and 211)
  • Pharma/Biopharma Industries Micro-Training Courses
  • CGMP Essentials for the Pharma/Biopharma industry
  • Quality Management Systems
  • Quality Culture
  • Problem Solving
  • ISO 9001:2015 Clause by Clause Classroom Training
  • Creating a Quality Culture
  • A3 Problem Solving Training Course
  • Introduction to HACCP Classroom Training
  • ISO 22000 Clause by Clause Classroom Training
  • Effective Meeting Skills Classroom Training
  • 5S Training Course
  • Mistake Proofing (Poka Yoke) Training
  • Failure Mode and Effect Analysis (FMEA)
  • Effective Technical Writing Skills
  • Medical Devices
  • Quality Management Systems
  • Food Safety Management (HACCP)
  • Internal Auditor ISO 13485:2016 Training Course
  • Introduction to CAPA for Medical Devices Training Course
  • Introduction to ISO 13485:2016 Training Course
  • EU Medical Device Regulation (MDR) 2017/745 Fundamentals Training Course
  • Internal Auditor ISO 9001:2015 Training Course
  • Introduction to ISO 9001:2015 Training Course
  • HACCP Food Safety Management Fundamentals Training Course
  • Blog
  • Glossary
  • FREE Micro-Learning Videos
  • Useful Links
  • eLearning FAQ

21 CFR 820 Subpart C (Medical Device Design Controls) Online Training Course

0
(0)
Instructor Image Dr. Fiona Masterson
5 Lessons
6 months
€245.00
Take this Course
€245.00
Take this Course
Course Details

21 CFR 820 Subpart C (Medical Device Design Controls) Online Training Course

Instructor Image Dr. Fiona Masterson
5 Lessons
1 Quiz
Certificate
0
(0)
6 months
Current Status
Not Enrolled
Price
€245.00
Get Started
Take this Course
Training Method

Self-paced elearning

Assessment

Quiz

Length of Course

2 - 3 hours. Learning times vary dependent on the learner’s preferred pace.

Accessibility

Closed Captions

Level of Difficulty

Intermediate (a basic knowledge of the topic but no regular professional usage).

Access to Content

6 months, 24/7 access

Certificate of Completion

A certificate of completion will be issued on successful course completion.



Course Description
Learning Objectives
Course Content
Certificate of Completion
Instructor
Course Description

This online training course will present an in-depth look at 21 CFR Part Subpart C Design Controls. Subpart C is an important element of the medical device Quality System Regulation (QSR). The learner will be given an insight into the form 483 design controls observations for FY2021.

 

Design controls are essential to ensuring a medical device idea achieves regulatory approval. Without design controls, you won’t be able to launch your product, while the poor implementation of design controls, particularly in the early stages of a project, will delay the launch of your product. Design controls increase the likelihood that the design transferred to production will translate into a device that is appropriate for its intended use.

Who should take this course?

  • This online course is suitable for professionals involved in the development of medical devices or planning to work in this area.
  • Individuals in the following positions or seeking these positions in the medical device industry: new product development/R&D engineers, project managers, regulatory affairs specialists. It is also suitable for Internal auditors. 
Learning Objectives

1. Learn about the content of Subpart C – Design Controls.

2. Learn about the relevance of Subpart C to 820.30 of the FDA’s Design Control Guidance For Medical Device Manufacturers.

3. Gain insight how design controls can be audited using the Quality System Inspection Technique manual.

4. Obtain knowledge about the design controls form 483 observations in FY2021. 

5. Learn about a Warning Letter documenting issues relating to Subpart C – Design Controls.

Course Content

The following topics will be covered in this course:

  • Each requirement within 21 CFR Part 820 Subpart C will be discussed.
  • Design development plan
  • User needs
  • Design inputs
  • Design outputs
  • Design review
  • Design verification
  • Design validation
  • Design transfer
  • Design changes
  • Design History File
  • The FDA’s Design Control Guidance For Medical Device Manufacturers and Quality System Inspection Technique manual.
  • FY2021 FDA form 483 observations for FY2021.
  • Warning Letter documenting issues relating to Subpart C – Design Controls.

 

Supplemental Material:

  1. Link to 21 CFR Part 820 Subpart C – Design Controls
  2. Quality System Inspection Technique.

 

Assessment: 

Quiz consisting of 10 questions.

Certificate of Completion

Upon completing the course and when you obtain a passing grade on your final quiz (80% or over), you will receive a PDF certificate to show that you have completed all the course content. 

Instructor

Fiona Masterson headshot

Dr. Fiona Masterson. 

Fiona is the founder of The Learning Reservoir. She has 25+ years of parallel paths in quality management, operations management and education. She has broad technical expertise encompassing quality systems compliance, quality standards implementation, regulatory affairs and operations management. She has worked in start-ups and high‐tech, fast paced manufacturing environments. She lectures part-time in technical universities on subjects related to her industrial expertise.

Fiona has Bachelor and Masters of Science degrees, and a Doctorate in Mechanical Engineering. Her Doctorate focused on innovative drug/device combinations products. Fiona is a certified lead auditor. Fiona has published in peer reviewed journals on topics such as medical device and pharmaceutical regulatory affairs, on-the job training and innovative training technologies and strategies.

She writes many of The Learning Reservoir’s blog posts and invites you to connect with her on LinkedIn. 

Ratings and Reviews

0.0
Avg. Rating
0 Ratings
5
0
4
0
3
0
2
0
1
0
What's your experience? We'd love to know!
Login to Review
No Reviews Found!
Show more reviews
What's your experience? We'd love to know!
Login to Review

ABOUT US

Provider of exceptional eLearning courses to the life sciences and manufacturing sectors.

USEFUL LINKS

  • Contact Us
  • About Us
  • FAQ

CONNECT

  • LinkedIn
  • Twitter
  • Instagram
Copyright 2023 - All Rights Reserved | The Learning Reservoir Ltd. | Privacy Policy | Terms and Conditions