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
21CFR211 Subpart C

cGMP 21 CFR Part 211 Subpart C – Buildings and Facilities Online Training Course

0
(0)
Instructor Image Dr. Fiona Masterson
4 Lessons
6 months
€215.00
Take this Course
€215.00
Take this Course
Course Details

cGMP 21 CFR Part 211 Subpart C – Buildings and Facilities Online Training Course

Instructor Image Dr. Fiona Masterson
4 Lessons
1 Quiz
Certificate
0
(0)
6 months
Current Status
Not Enrolled
Price
€215.00
Get Started
Take this Course

Course Description

Training Method

Self-paced elearning

Assessment

Quiz

Length of Course

Allow 1 hour to complete the course. 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 certificates of completion will be issued on successful course completion.



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

In this course you will learn about 21 CFR Part 211 Subpart C – Building and Facilities.   21 CFR Part 211 Subpart C can be found in 21 Code of Federal Regulations Part 211: the cGMP in Manufacturing, Processing, Packaging, or Holding of Drugs (21 cfr 211).

FDA ensures the quality of drug products by carefully monitoring drug manufacturers’ compliance with its cGMP regulations. The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.

21 CFR 211 Subpart C is an important element of the cGMP programme. The facility and buildings in which pharmaceuticals are manufactured must comply with these cGMP regulations. 

 

Who should take this course?

  • Any new or existing manufacturing and quality department personnel, suppliers or contractors involved in operations pertaining to pharmaceuticals.
  • Anyone needing to understand cGMP regulations for the building and facilities where pharmaceuticals are manufactured.
Learning Objectives

1. Gain an understanding of the contents of 21 CFR 211.

2. Learn where Subpart C fits into 21 CFR 211.

3. Learn about the  contents of the different sections of  21 CFR Part 211 Subpart C – Building and Facilities.

 

Course Content

The following topics will be covered in this course:

  • Overview of 21 CR 211.
  • 21 CFR Part 211 Subpart C requirements.
  • Practical things to consider when complying with the requirements within Subpart C.

Supplemental Material:

  1. Link to 21 CFR 211.
  2. Link to 21 CFR Part 820 Subpart C – Building and Facilities.

Assessment:

There will be an end of course quiz. 

Certificate of Completion

Upon completing any course and successfully achieved 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. 

You will be allowed 3 attempts to pass the quiz. 

Instructor

Dr. Fiona Masterson.

Fiona has 20+ years of parallel paths in quality management, operations management and education. She is a highly experienced quality and training professional, with broad technical expertise encompassing quality systems compliance, quality standards implementation, regulatory affairs and operations management. she is experienced with start-ups and high‐tech, fast paced manufacturing environments.

Fiona has a Bachelor of Science degree in Food Science, a Master of Science degree in Quality and Operations Management, and a Doctorate in Mechanical Engineering. Her Doctorate focused on innovative drug/device combinations products. Fiona is also a certified lead auditor.Fiona has published in peer reviewed journals on topics such as regulatory affairs and innovative training methodologies

She writes many 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