GMP Publications - Code of Federal Regulation Handbooks by the FDA

Medical Device - 25 GMP Handbooks and 8-hour Webinar - $5,995.00 - More information

GMP Publications and Boot Camp

Medical Device GMP Training and Handbooks:

GMP Handbooks and 8-hour GMP Training Package for 25 People.

Taught by the leading GMP Expert and Senior Auditor for The Auditing Group and GMP Boot Camps.

Focus on:

  • Basic GMP and QMS Overview
  • 21 CFR Part 11 Overview
  • 21 CFR Part 820 Quality Systems Regulation

Turn-key training includes:

Basic Medical Device GMP 101 Overview:

2 hour GMP 101 The Basics (Satisfies the annual GMP Training Requirements)

  • GMP - What is cGMP and the GMP Lifestyle?
  • The Agency History and Objectives
  • Roles and Responsibilities
  • The 10 Principals of GMP
  • Writing Procedures
  • Facility Management
  • Agency Inspections and 483s
  • The 5 Basic Binders The Quality Manual
  • IT Strategy Plan
  • Standard Operating Procedures
  • Validation Documentation
  • Drug/Device Documentation

2 hour 21 CFR Part 11 Basic Overview

  • 21 CFR Part 11 Definitions, System Types and Classifications
  • 21 CFR Part 11 Electronic Records; Electronic Signatures – Predicate Rule
  • Part 11.10 Sections a) - k) (a) Validation
    (b) Copies of records
    (c) Protection of records
    (d) Limiting system access
    (e) Audit trails
    (f) Operational system checks
    (g) Authority checks (h) Device checks
    (i) Education, Training, Experience
    (j) Policies and Procedures
    (k) Systems documentation
  • Scope and Application Risk Analysis - Determine Which Systems Need to be Validated

- Lunch

- 21 CFR Part 820 Quality Systems Regulations (QSR) GMPs

  • Scope and Definitions
  • Quality System Requirements
  • Management responsibility
  • Quality audit
  • Personnel Requirements
  • Design Controls
  • Document Controls
  • Purchasing Controls
  • Identification and Traceability - Recall Process
  • 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 and Distribution
  • Installation Requirements
  • Records - General requirements
  • Records - Device master record
  • Records - Device history record
  • Records - Quality system record
  • Records - Complaint files
  • Servicing
  • Statistical Techniques
  • Corrective and Preventive Actions (CAPAs)

- Questions and Answers


$7,995.00 $5,995.00 On Sale!




Upgrade your order or view other GMP Products that you may be interested in:

Banner-Monthly-200811-1-266
8-Hour GMP QMS Webinar Training

Calendar:

  • December 28, 2020
  • January 25, 2021
  • February 23, 2021
  • March 23, 2021
  • April 27, 2021
  • May 25, 2021
  • June 22, 2021
  • July 27, 2021

GMP QMS 101 The Basics - The required GMP Training for all employees who operate under Title 21 Compliance Requirements.

  • GMP - What is cGMP and the GMP Lifestyle?
  • The Agency History and Objectives
  • Roles and Responsibilities
  • The 10 Principals of GMP
  • Good Documentation Practices (GDocP)
  • Facility Management
  • The History of GMP, the Agency Inspections and 483s
  • Warning Letter Reviews

21 CFR Part 11 Electronic Records

  • 21 CFR Part 11 Basic Overview
    • 21 CFR Part 11 Definitions, System Types and Classifications
    • 21 CFR Part 11 Electronic Records; Electronic Signatures – Predicate Rule
    • Part 11.10 Sections a) - k)
    - - Validation
    - - Copies of records
    - - Protection of records
    - - Limiting system access
    - - Audit trails
    - - Operational system checks
    - - Authority checks (h) Device checks
    - - Education, Training, Experience
    - - Policies and Procedures
    - - Systems documentation
    • Scope and Application Risk Analysis - Determine Which Systems Need to be Validated
    • Steering Committee and Part 11 Initiatives

Good Auditing Practice

  • The Auditor's Basics 101 'From the Auditor's Perspective'
  • The 5 Basic Binders
  • The Quality Manual
  • IT Strategy Plan
  • Standard Operating Procedures
  • Validation Documentation
  • Drug/Device Documentation

The QMS Basics

- - CAPA
- - Non-Conformance
- - Change Control
- - Deviations
- - Out of Specifications / Out of Trend
- - Complaints
- - Recalls
- - Product Traceability
- - Audit - Internal, Agency, Customers and External Audit
- - Vendors, Suppliers, Contractors and Consultants
- - Basic Risk Management
- - Training Program

Questions and Answers

 

Includes:
- - Binders (shipped free for US Customers)
- - Handbooks
- - Certificate of Attendance (Completion)

Quantity
example: 211, ISBN, Drug, GMP, Etc. - Press Enter
GMP Training Mix and Match Clinical Manufacturing Handbook End of Year Special Featured Publication GCP Device GMP GCP-DRUG Featured Publication
  • Guaranteed Lowest Price
  • Quantity Discounts Available
  • Always Current, Up-To-Date
  • Company Logos Available
  • Special Customizations
  • Pocket-sized 3.75" x 6.25"
  • Prep for FDA & Client Audits
  • Employee Training & Reference
  • Promotional "giveaways"
  • Tradeshows and meetings

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