Course Agenda:
please see brochure for times

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 History of GMP, the FDA Agency, Agency Inspections, Warning letters and 483s
• Warning Letter Reviews (Review of actual violations)
• Quality Terminology

The QMS Basics

• CAPA - Everything you wanted to know about CAPA,
• Non-Conformance - From Materials Supply to Production,
• Deviations - Deviation management is essential for every company,
• Change Control - Documentation, Engineering, Production and Distribution,
• Out of Specifications / Out of Trend - Correct Management of OOS and OOT for regulated industry,
• Complaints - Receipt, Qualifications, Risk Assessments and Remediation/Resolution,
• Product Traceability - The most under-rated requirement in the industry today,
• Recalls - The process, rationale for plan for success,
• Quality Review and Management Review - Processes for meeting the requirements for annual reviews,
• Vendors, Suppliers, Contractors and Consultants; The Qualification Process explained. The Quality Agreements,
  
• The 11 General Orders / Principals of GMP
• Writing Procedures (with template examples);
• Following Procedures (and the failures that occur);
• Documentation (Requirements, and the Regulations);
• Validation (Concepts, and basic process requirements);
• Design/Build Facilities and Equipment (In-depth look into a GMP facility requirement);
• Maintain Facilities and Equipment (Maintenance, Calibration, Use and Cleaning of Facilities/Equipment);
• Competency (The Training Requirements);
• Sanitation and Good Housekeeping Practices (General requirements for all facilities);
• Control for Quality (from Materials Receipt, Production, Packaging and Distribution);
• Audit Requirements
• 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)
• Validation
• Copies of records
• Protection of records
• Limiting system access
• Audit trails
• Operational system checks
• Authority checks
• Device checks
• Education, Training, Experience
• Policies and Procedures
• Systems documentation
• Microsoft Excel