INTERPRETATION & APPLICATION OF 21 CFR 820

Course Content

Total learning: 23 lessons / 10 quizzes Total Training Hours: 14 hours

  • BRIEF INTRODUCTION TO ISO 13485:2016: MEDICAL DEVICES - QMS  0/1

    • Lecture1.1
      Requirements For Regulatory Purposes

  • PART 820: MEDICAL DEVICE – QUALITY SYSTEM REGULATION  0/15

    • Lecture2.1
      Subpart A–General Provisions 820.1 – Scope. 820.3 – Definitions. 820.5 – Quality system.
    • Lecture2.2
      Subpart B–Quality System Requirements 820.20 – Management responsibility. 820.22 – Quality audit. 820.25 – Personnel.
    • Lecture2.3
      Subpart C–Design Controls 820.30 – Design controls.
    • Lecture2.4
      Subpart D–Document Control 820.40 – Document controls.
    • Lecture2.5
      Subpart E–Purchasing Controls 820.50 – Purchasing controls.
    • Lecture2.6
      Subpart F–Identification and Traceability 820.60 – Identification. 820.65 – Traceability.
    • Lecture2.7
      Subpart G–Production and Process Controls 820.70 – Production and process controls. 820.72 – Inspection, measuring, and test equipment. 820.75 – Process validation.
    • Lecture2.8
      Subpart H–Acceptance Activities 820.80 – Receiving, in-process, and finished device acceptance. 820.86 – Acceptance status.
    • Lecture2.9
      Subpart I–Nonconforming Product 820.90 – Nonconforming product.
    • Lecture2.10
      Subpart J–Corrective and Preventive Action 820.100 – Corrective and preventive action.
    • Lecture2.11
      Subpart K–Labelling and Packaging Control 820.120 – Device labelling. 820.130 – Device packaging.
    • Lecture2.12
      Subpart L–Handling, Storage, Distribution, and Installation 820.140 – Handling. 820.150 – Storage. 820.160 – Distribution. 820.170 – Installation.
    • Lecture2.13
      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.
    • Lecture2.14
      Subpart N—Servicing 820.200 – Servicing.
    • Lecture2.15
      Subpart O–Statistical Techniques 820.250 – Statistical techniques

  • TECHNICAL ASPECTS OF THE QUALITY SYSTEM REGULATION:  0/16

    • Lecture3.1
      Product Design Input & Product Design Review
    • Lecture3.2
      Product Design Output & Product Design Verification
    • Lecture3.3
      Process Design Input & Process Design Review
    • Lecture3.4
      Process Design Output & Process Design Verification
    • Lecture3.5
      Product & Process Design Validation
    • Lecture3.6
      Product & Process Design Transfer
    • Quiz3.1
      Product & Process Design Change 0 question10 min
    • Quiz3.2
      Design History File 0 question10 min
    • Quiz3.3
      Application of Statistical Control Techniques: Control Charts 0 question10 min
    • Quiz3.4
      Computation & Interpretation of Pp, PpK, Cp & CpK 0 question10 min
    • Quiz3.5
      Determination of Measurement System Capability: Discrimination Ratio, GRR% & ndc 0 question10 min
    • Quiz3.6
      Establish Effective Calibration System: Reference Standard, Reference Materials, Measurement Error, Correction Factor, Measurement Uncertainty & Measurement Traceability 0 question10 min
    • Quiz3.7
      Process Validation Protocol & Techniques: IQ (Installation Qualification), OQ (Operational Qualification) & PQ (Performance Qualification) 0 question10 min
    • Quiz3.8
      Review and Compilation of Device Master Record 0 question10 min
    • Quiz3.9
      Review and Compilation of Device history record. 0 question10 min
    • Quiz3.10
      Review and compilation of Complaint files. 0 question10 min

  • ASSESSMENT  0/1

    • Lecture4.1
      Classroom Exercises and Assessment Tests
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