INTERPRETATION & APPLICATION OF 21 CFR 820
Current Good Manufacturing Practice (cGMP) requirements are set forth in this quality system regulation.
Curriculum
- 4 Sections
- 23 Lessons
- 14 Hours
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- BRIEF INTRODUCTION TO ISO 13485:2016: MEDICAL DEVICES - QMS1
- PART 820: MEDICAL DEVICE – QUALITY SYSTEM REGULATION15
- 3.1Subpart A–General Provisions 820.1 – Scope. 820.3 – Definitions. 820.5 – Quality system.
- 3.2Subpart B–Quality System Requirements 820.20 – Management responsibility. 820.22 – Quality audit. 820.25 – Personnel.
- 3.3Subpart C–Design Controls 820.30 – Design controls.
- 3.4Subpart D–Document Control 820.40 – Document controls.
- 3.5Subpart E–Purchasing Controls 820.50 – Purchasing controls.
- 3.6Subpart F–Identification and Traceability 820.60 – Identification. 820.65 – Traceability.
- 3.7Subpart G–Production and Process Controls 820.70 – Production and process controls. 820.72 – Inspection, measuring, and test equipment. 820.75 – Process validation.
- 3.8Subpart H–Acceptance Activities 820.80 – Receiving, in-process, and finished device acceptance. 820.86 – Acceptance status.
- 3.9Subpart I–Nonconforming Product 820.90 – Nonconforming product.
- 3.10Subpart J–Corrective and Preventive Action 820.100 – Corrective and preventive action.
- 3.11Subpart K–Labelling and Packaging Control 820.120 – Device labelling. 820.130 – Device packaging.
- 3.12Subpart L–Handling, Storage, Distribution, and Installation 820.140 – Handling. 820.150 – Storage. 820.160 – Distribution. 820.170 – Installation.
- 3.13Subpart 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.
- 3.14Subpart N—Servicing 820.200 – Servicing.
- 3.15Subpart O–Statistical Techniques 820.250 – Statistical techniques
- TECHNICAL ASPECTS OF THE QUALITY SYSTEM REGULATION:16
- 4.1Product Design Input & Product Design Review
- 4.2Product Design Output & Product Design Verification
- 4.3Process Design Input & Process Design Review
- 4.4Process Design Output & Process Design Verification
- 4.5Product & Process Design Validation
- 4.6Product & Process Design Transfer
- 4.7Product & Process Design Change10 Minutes0 Questions
- 4.8Design History File10 Minutes0 Questions
- 4.9Application of Statistical Control Techniques: Control Charts10 Minutes0 Questions
- 4.10Computation & Interpretation of Pp, PpK, Cp & CpK10 Minutes0 Questions
- 4.11Determination of Measurement System Capability: Discrimination Ratio, GRR% & ndc10 Minutes0 Questions
- 4.12Establish Effective Calibration System: Reference Standard, Reference Materials, Measurement Error, Correction Factor, Measurement Uncertainty & Measurement Traceability10 Minutes0 Questions
- 4.13Process Validation Protocol & Techniques: IQ (Installation Qualification), OQ (Operational Qualification) & PQ (Performance Qualification)10 Minutes0 Questions
- 4.14Review and Compilation of Device Master Record10 Minutes0 Questions
- 4.15Review and Compilation of Device history record.10 Minutes0 Questions
- 4.16Review and compilation of Complaint files.10 Minutes0 Questions
- ASSESSMENT1
Review and compilation of Complaint files.
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