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SQI
- ISO Standards
- 14 hours
Introduction
Title 21: Food and Drug
Part 820: Quality System Regulation
Current Good Manufacturing Practice (cGMP) requirements are set forth in this quality system regulation. The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labelling, storage, installation, and servicing of all finished devices intended for human use. The requirements in this part are intended to ensure that finished devices will be safe and effective in compliance.
Learning Objectives
This program is designed to equip the participants with the practical knowledge to interpret 21 CFR 820 with a view to establish and integrate the Quality System Regulation into the ISO 13485:2016 Quality System Documentation effectively for the manufacture of Medical Devices.
Duration
2 days | 9am – 5pm | 14 hours
Who Should Attend
This program is designed for R&D, Technical, QC/QA/RA, Engineering and Production personnel who are involved in implementing 21 CFR Part 820 in their manufacturing environment.
Entry Requirement
Basic understanding on ISO 9001:2015 and/or ISO 13485:2016 Quality System Requirements is preferred.
Course Fees
Member: S$1101.60
Non-Member: S$1166.40
Registration Fee of S$17.28 apply.
All fees stated are inclusive of 8% GST
Award of Certificate
Certificate of Completion will be issued to participants who have attended at least 75% of the course.
Course Content
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BRIEF INTRODUCTION TO ISO 13485:2016: MEDICAL DEVICES - QMS
- Requirements For Regulatory Purposes
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PART 820: MEDICAL DEVICE – QUALITY SYSTEM REGULATION
- Subpart A–General Provisions 820.1 – Scope. 820.3 – Definitions. 820.5 – Quality system.
- Subpart B–Quality System Requirements 820.20 – Management responsibility. 820.22 – Quality audit. 820.25 – Personnel.
- Subpart C–Design Controls 820.30 – Design controls.
- Subpart D–Document Control 820.40 – Document controls.
- Subpart E–Purchasing Controls 820.50 – Purchasing controls.
- Subpart F–Identification and Traceability 820.60 – Identification. 820.65 – Traceability.
- Subpart G–Production and Process Controls 820.70 – Production and process controls. 820.72 – Inspection, measuring, and test equipment. 820.75 – Process validation.
- Subpart H–Acceptance Activities 820.80 – Receiving, in-process, and finished device acceptance. 820.86 – Acceptance status.
- Subpart I–Nonconforming Product 820.90 – Nonconforming product.
- Subpart J–Corrective and Preventive Action 820.100 – Corrective and preventive action.
- Subpart K–Labelling and Packaging Control 820.120 – Device labelling. 820.130 – Device packaging.
- Subpart L–Handling, Storage, Distribution, and Installation 820.140 – Handling. 820.150 – Storage. 820.160 – Distribution. 820.170 – Installation.
- Subpart M—Records 820.180 – General requirements. 820.181 – Device master record 820.184 – Device history record 820.186 – Quality system record 820.198 – Complaint files.
- Subpart N—Servicing 820.200 – Servicing.
- Subpart O–Statistical Techniques 820.250 – Statistical techniques
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TECHNICAL ASPECTS OF THE QUALITY SYSTEM REGULATION:
- Product Design Input & Product Design Review
- Product Design Output & Product Design Verification
- Process Design Input & Process Design Review
- Process Design Output & Process Design Verification
- Product & Process Design Validation
- Product & Process Design Transfer
- Product & Process Design Change
- Design History File
- Application of Statistical Control Techniques: Control Charts
- Computation & Interpretation of Pp, PpK, Cp & CpK
- Determination of Measurement System Capability: Discrimination Ratio, GRR% & ndc
- Establish Effective Calibration System: Reference Standard, Reference Materials, Measurement Error, Correction Factor, Measurement Uncertainty & Measurement Traceability
- Process Validation Protocol & Techniques: IQ (Installation Qualification), OQ (Operational Qualification) & PQ (Performance Qualification)
- Review and Compilation of Device Master Record
- Review and Compilation of Device history record.
- Review and compilation of Complaint files.
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ASSESSMENT
- Classroom Exercises and Assessment Tests
Trainer
