Course Agenda

GMP QMS 101 The Basics - The required GMP Training for all employees who work in regulated industry.

• GMP and the GMP Focus and the GMP Lifestyle

• The Predicate Rules

• The FDA Agency, Inspections, Warning letters and 483s

• Quality Terminology

 

The Quality Management System (QMS)

• The Basics of QMS

• CAPA - The basics about Corrective and Preventive Actions;

• Non-Conformance - Materials Supply, Specifications and Quality;

• Change Control - Documentation, Engineering, Production and Distribution;

• Deviations - Deviation management essentials;

• Out of Specifications / Out of Trend - Management of OOS and OOT;

• Complaints - Receipt, Qualifications, Risk Assessments and Remediation/Resolution;

• Recalls - The process, and indications of failures;

• Product Traceability;

• Audit - Internal, Agency, Customers and External Audit;

• Vendors, Suppliers and Contractors - Quality Agreements;

• The Meetings - Management and Quality Meetings;
   

• The 11 General Orders / Principals of GMP

  1. Writing Procedures (with template examples);

  2. Following Procedures (and the failures that occur);

  3. Documentation (Requirements, and the Regulations);

  4. Validation (Concepts, and basic process requirements);

  5. Design/Build Facilities and Equipment (In-depth look into a GMP facility requirement);

  6. Maintain Facilities and Equipment (Maintenance, Calibration, Use and Cleaning of Facilities/Equipment);

  7. Competency (The Training Requirements);

  8. Sanitation and Good Housekeeping Practices (General requirements for all facilities);

  9. Control for Quality (from Materials Receipt, Production, Packaging and Distribution);

  10. Audit Requirements

  11. Prepare for Battle! The Traceability Process;

 

21 CFR Part 11 Electronic Records

• 21 CFR Part 11 Basic Overview

• Definitions, System Types and Classifications

• 21 CFR Part 11 – Predicate Rule

• Part 11.10 Sections a) - k)

• Microsoft Excel