GMP Publications - Code of Federal Regulation Handbooks by the FDA

21 CFR 11, 820 - Electronic Records with Quality Systems Regulations

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1-933734-06-X

US FDA Title 21 CFR Parts

Part 11 - Electronic Records/Electronic Signatures (ERES)
Part 820 - Quality Systems Regulations



























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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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