GMP Publications - Code of Federal Regulation Handbooks by the FDA

21 CFR 820 with Medical Device QSIT Manual

10Part820.jpg
978-1-935131-17-5

US FDA Title 21 CFR Parts

Part 820 - Quality Systems Regulation

Quality System Inspection Technique

Guide to Inspections of Quality Systems























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Day 1 Topics Day 2 Topics

21 CFR Part 820 Device GMPs

  • GMP Basics 101
  • Part 11 Overview
  • Scope and Definitions
  • Quality System Requirements
  • Management responsibility
  • Quality audit
  • Personnel
  • Design Controls
  • Document Controls
  • Purchasing Controls
  • Identification and Traceability
  • Production and process controls
  • Inspection, measuring, and test equipment
  • Process validation
  • Acceptance Activities
  • Receiving, in-process, and finished device acceptance
  • Acceptance status
  • Nonconforming product
  • Corrective and preventive action
  • Device labeling
  • Device packaging
  • Handling
  • Storage
  • Distribution
  • Installation
  • Records - General requirements
  • Records - Device master record
  • Records - Device history record
  • Records - Quality system record
  • Records - Complaint files
  • Servicing
  • Statistical Techniques

21 CFR Part 803 Medical Device Reporting - Basics

Part 11 and Systems Validation:

  • 21 CFR Part 11 History
  • 21 CFR Brief Overview
  • Definitions, System Types and Classifications
  • The Systems and Software Types
  • 21 CFR Part 11 Electronic Records; Electronic Signatures – Predicate Rule
  • 21 CFR Part 11 a) - k) Requirements
  • Setting up the Steering Committee and Charter
  • Conducting the Inventories
  • Risk Analysis - How to classify risks
  • Determine Which Systems Need to be Validated

QSIT - The Basics

Validation and Qualification
  • Definitions
  • GAMP Overview
  • Risk Analysis - Determine Which Systems Need to be Validated
  • Software / System Development Life Cycle (SDLC)
  • Compiling the Validation Master Plan (VMP)
  • Project Plan (PP) Development
  • User Requirement Specifications (URS)
  • Functional Requirement Specifications (FRS)
  • Design Specifications / Design Qualifications (DQ)
  • Installation Qualifications (IQ)
  • Operational Qualifications (OQ)
  • Performance Qualifications (PQ)
  • Auditing GxP Computer Systems

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MedDeviceQualitySysMan.AuditChecklist11.210211.jpg
Medical Device Quality Systems Manual with 11, 210/211, 820 and QSR Audit Checklist

Medical Device Quality System Manual with 11, 210/211 & 820 QSR with the QSR Audit Check List

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Medical Device Quality Systems Manual with 11, 820, QSR Audit Checklist, 7382.845 with QSIT

Medical Device Quality System Manual with 11, 820 QSR with QSR Audit Check List, QSIT and 7382.845 FDA Inspector's Manual

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