This  online training course will present an in-depth look at 21 CFR Part Subpart B Quality System Requirements. Subpart B covers management responsibility, quality audit and personnel. Participants will also learn about Quality System Inspection Technique (QSIT). 

It is particularity important that leadership teams and management working in the medical device industry understand the contents of subpart B. Company management is responsible for establishing policies, objectives and designing organizational structures. Management are responsible for ensuring that personnel are adequate trained. They must ensure resources are available to put in place and maintain the quality management system. 

QSIT provides guidance to the FDA field staff on the inspectional process that may be used to assess a medical device manufacturer’s compliance with the QSR. Field investigators generally will use this guidance material to help them focus on key elements of a firm’s quality system. The guidance emphasizes management responsibility for establishing effective quality systems.

You will gain access to the following documents when you purchase the course:

• Sample Internal Audit Schedule
• Sample Internal Audit procedure
• Sample Internal Audit Checklist
• Sample Audit Form (for recording audits)

Who should take this course?

• This course is suitable for all functions and levels of an organization who need to gain understanding of Subpart B of the US FDA 21 CFR Part 820.
• Individuals working in human resources and in supervisor/managerial roles.
• Individuals involved in running the company’s internal auditing program.
• Individuals in the following positions or seeking these positions in the medical device industry: general managers, production managers, directors, supervisors and Internal Auditors.

1. Learn about the content of 21 CFR 820 Subpart B.

2. Understand the requirements for an internal auditing program in a medical device company.

3. Understand the training and educational requirements for employees in a medical device company.

4. Learn about warning letters documenting issues relating to 21 CFR 820 Subpart B.

5. Obtain knowledge about the Quality System Inspection Technique (QSIT).

Topics covered in this course include

• Review the contents of 21 CFR 820.20 Medical Device Management Responsibility. 
• Review the contents of 21 CFR 820.22 Quality Audit.
• Review the contents of 21 CFR 820.25 Medical Device Management Responsibility. 
• What are management of a medical device company responsible for?
• Quality policy.
• Understanding the meaning of management with executive responsibility.
• Organizational structures.
• Appropriate resources.
• Management representative.
• Job descriptions.
• Management review.
• Planning.
• Warning letter containing Subpart B non compliances. 
• Quality system procedures.
• Steps in conducting a quality audit.
• The internal audit schedule.
• The internal audit procedure.
• The internal audit checklist.
• The audit form (for recording audits)
• Personnel training requirements.
• Quality System Inspection Technique.
• QSIT approach to auditing Management Controls

Supplemental Material:

• Link to 21 CFR Part 820 Subpart B 
• Downloadable sample Qualify Policy (in .pdf format.)
• Sample Internal Audit Schedule
• Sample Internal Audit procedure
• Sample Internal Audit Checklist
• Sample Audit Form (for recording audits)

Assessment:

There is a quiz, consisting of 15 questions.

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. 

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.