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

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:

• 25 Medical Device GMP Handbooks
• 25 Course Binders
• 25 Certificates of Attendance

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