Quality Performance Improvement
Training Synopsis
This training is designed to provide the best overview for all personnel directly involved in the understanding, implementation and maintaining this Quality System Regulation (QSR).
Introduction
Learning Objective
Duration
Methodology
Target Participants
Course Outline
Training Certificate
Why Us?
Introduction
US FDA 21 CFR Part 820, also known as the Quality System Regulation (QSR) Requirements for Medical Device Manufacturers, outlines Current Good Manufacturing Practice (cGMP) regulations that govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use.
These requirements are meant to ensure that medical devices are safe and effective. Manufacturers must establish and follow quality systems for FDA-regulated products (food, drugs, biologics, and devices) to help ensure that their products consistently meet applicable requirements and specifications.
For organizations embarking on its up beating journey towards US FDA 21 Part 820 requirements, this foundation training course will provide the best overview for all personnel directly involved in the understanding, implementation and maintaining this Quality System Regulation (QSR).
Learning Objective
This foundation training course aims to provide participants with a clear understanding and insight into the US FDA 21 CFR Part 820 (QSR) requirements and its relationship to ISO 13485:2016. There will be a detailed clause by clause analysis and explanation of Part 820 Quality System Regulation and the participants will have a better understanding the FDA requirements.
By the end of the training, participants would be able to:
- Understand the fundamentals of FDA 21 CFR Part 820 QSR
- FDA Quality System Inspection Techniques (QSIT)
- FDA Mandatory Medical Report System
- FDA Inspection SOP
Duration
1 day (9.00am to 5.00pm) or duration proposed at quotation.
Methodology
Training session includes classroom lecture, exercises, group work and discussion.
Target Participants
The management, supervisory and shop floor personnel preparing themselves towards gaining the knowledge of US FDA 21 CFR Part 820 QSR requirements.
Course Outline
- Background of Department of Health and Human Services, Center for Devices & Radiological Health (CDRH), FDA, and CFR Part 820 QSR
- Part 820 Quality System Regulation
- FDA Quality System Inspection Techniques (QSIT)
- FDA Mandatory Medical Report System
- FDA Inspection SOP
Training Certificate
Certificate of Attendance will be issued to participants who fully participated the training and satisfied the attendance requirements.
Why Engage aNTS / Peplow-Warren?
Peplow-Warren Consultant Team is formed by a group of experienced sector expert, certification auditors, consultants and industry practitioners. They actively involve in international standard and specifications development by acting as active ISO and MOSTI Technical Committee Member. They carry a common mission: they are willing to share their good knowledge with current industry practitioners. Call us today for more detail. We are obliged to work together and grow your business.
Investment
Contact our Customer Care Hotline 012-713 3356 / 011-2128 4750 or email to ntsask@gmail.com / sales@peplow-warren.com for your best solution and offer.