Auditing and Validation Services for FDA Regulated Industry

 

   

 

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Location

1 Day GMP QMS Basics Boot Camp

All Boot Camps Includes:

  • Travel
  • Hotels
  • Expenses
  • Up to 10 Binders, Handbooks and Certificates*
* Additional copies available for $50.00 each
Topics

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

The QMS Basics

  • Quality Terminology
  • CAPA - Everything you wanted to know about CAPA,
  • Non-Conformance - From Materials Supply to Production to End of Use Complaints,
  • 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);
    • Prepare for Battle! The Traceability Process.

Good Auditing Practice and QMS Prerequisites

  • The Auditor/Auditee’s Basics 101
  • The 5 Basic Binders
    • The Quality Manual
    • IT Strategy Plan
    • Standard Operating Procedures
    • Validation Documentation
    • Drug/Device Documentation

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 (h) Device checks
      - - Education, Training, Experience
      - - Policies and Procedures
      - - Systems documentation
    • Scope and Application Risk Analysis - Determine Which Systems Need to be Validated
    • The Part 11 Initiatives
    • Microsoft Excel

    Questions and Answers

 

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