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
Image of lab scientist

21 CFR Part 210 – cGMP in Manufacturing, Processing, Packing, or Holding of Drugs Online Training Course

0
(0)
Instructor Image Dr. Fiona Masterson
5 Lessons
6 months
€295.00
Take this Course
€295.00
Take this Course
Course Details

21 CFR Part 210 – cGMP in Manufacturing, Processing, Packing, or Holding of Drugs Online Training Course

Instructor Image Dr. Fiona Masterson
5 Lessons
1 Quiz
Certificate
0
(0)
6 months
Current Status
Not Enrolled
Price
€295.00
Get Started
Take this Course

Course Description

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

Beginner (no knowledge at all of the topic)

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

In this course, 21 CFR Part 210 – cGMP in Manufacturing, Processing, Packing, or Holding of Drugs Online Training Course, you will learn about Title 21 of the US Code of Federal Regulations, Part 210 (21 CFR 210). The FDA current good manufacturing practices (cGMP) regulations for drugs are published in this title in addition to 21 CFR 211.

cGMPs is a system for ensuring products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. In this 21 CFR Part 210 training course you will learn the fundamentals of the drug cGMPs.

Who should take this course?

  • Those who work in a current Good Manufacturing Practices (cGMP) environment (from beginner to advanced professionals) and those whose roles and responsibilities require they understand and apply cGMP quality principles to their job.
  • All employees, contractors, consultants, and suppliers currently supporting or wanting to support FDA cGMP regulated activities.
  • Professionals who wish to work in the pharmaceutical manufacturing setting. 
Learning Objectives
  1. Understand drug cGMPs.
  2. Gain knowledge about where the cGMP regulations came from.
  3. Understand what the Food Drug and Cosmetics Act 1938 is.
  4. Have knowledge of the content and structure of 21 CFR 210.
  5. Gain knowledge of terms used in 21 CFR 210.
  6. Gain knowledge about what types of cGMP violations appear in FDA warning letters.
Course Content

Topics covered in this course

  • Review of each section of 21 CFR 210.
  • Review of definitions contained within 21 CFR 210.
  • Review of warning letters that document to cGMP violations.

Assessment: 

End of course quiz.

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