GMP Publications - Code of Federal Regulation Handbooks by the FDA

1 Day Medical Device QSR GMP Bootcamp - US - 20 free GMP Master Handbooks

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You have the books, now get the training!

GMP Publications Special - $3,495.00 - All Inclusive 1 day bootcamp seminar - Includes Course Binders, Handbooks, and Certificates for up to 20* Attendees, Travel, Hotels and Expenses - Conducted by The Auditing Group.

- For more details, call 856-810-7331
- *Additional attendee binders (over 20) will be charged $25.00 USD each.

 

 

Day 1 Topics

21 CFR Part 820 Medical Device QSR GMPs

  • GMP 101 - The Basics
  • 21 CFR Part 11 Overview
  • 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 - The Basics

21 CFR Part 11 and Systems Validation The Basics:

  • 21 CFR Part 11 Definitions, System Types and Classifications
  • 21 CFR Part 11 Electronic Records; Electronic Signatures – Predicate Rule
  • 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

$3,495.00



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