Basic GMP/QMS - 25 Basic GMP Handbooks and 4-hour Webinar - $2,995.00 - More information

Basic GMP and QMS Training and Handbooks:

GMP Handbooks and 4-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

Turn-key training includes:

• 25 Standard GMP Handbooks for Drug and Medical Device Industry
• 25 Course Binders
• 25 Certificates of Attendance

Basic GMP 101 Overview:

2.5 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
• 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

1.5 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

- Questions and Answers