Auditing and Validation Services for FDA Regulated Industry

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8-hour cGMP Boot Camp 102 focuses on;
- The cGMP Basics 101
- Part 11 Electronic Records; Electronic Signatures
- The Auditor's Basics
- The QMS Requirements

- - Course Materials (450+ Slides)
- - Certificate of Attendance (Completion)

Next Available Dates:
  • April 27, 2021
  • May 25, 2021
  • June 22, 2021
  • July 27, 2021

Taught by Auditing SMEs 'From the Auditor's Perspective'

Your annual cGMP Training at home, at your convenience.
Sign up today to secure your seat!


Course Agenda (Download the Agenda) please see brochure for times.

GMP QMS 101 The Basics - The required GMP / QMS Training for all employees!

  • GMP - What is cGMP and the GMP Lifestyle?
  • The History of GMP, the Agency Inspections and 483s
  • Warning Letter Reviews (Review of actual 483 violations and warning letters)
  • The 11 General Orders or Principals of GMP
    • Writing Procedures (with template examples)
    • Following Procedures (and the failures that occur)
    • Documentation (Rationale, 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 (The Maintenance, Calibration, Use and Cleaning of Facilities and 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 for Compliance (Basic Audit Concepts)
    • Prepare for BATTLE! - The Traceability Audit!

Good Auditing Practice

  • The Auditor's Basics 101 'From the Auditor's Perspective'
  • The 5 Basic Binders
  • The Quality Manual
  • IT Strategy Plan
  • Standard Operating Procedures
  • Validation Documentation
  • Drug/Device Documentation

The QMS Basics

  • CAPA - Everything you wanted to know about CAPA,
  • Non-Conformance - From Materials Supply, to Production to End of Use Complaints,
  • Change Control - Documentation, Engineering, Production and Distribution,
  • Deviations - Proper deviation management is essential for every company,
  • Out of Specifications / Out of Trend - Correct Management of OOS and OOT for regulated industry,
  • Complaints - Receipt, Qualifications, Risk Assessments and Remediation/Resolution,
  • Recalls - The process, and rationale for success, and indications of failures,
  • Product Traceability - The most under-rated requirement in the industry today,
  • Audit - Internal, Agency, Customers and External Audit - Receiving, Conducting, and Self Assessments,
  • Vendors, Suppliers, Contractors and Consultants - The Qualification Process explained. The Quality Agreements,

21 CFR Part 11 Electronic Records

  • 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)
    - - 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

Questions and Answers

Presenter / Auditor
Mr. John F. Cuspilich, Sr. Instructor
CEO of GMP Publications - The Auditing Group and The Validation Group

John is the CEO and Senior Auditor for The Auditing Group, Inc. (

John also serves as the Senior Editor at GMP Publications, Inc. and the CEO of The Validation Group.

John has conducted more than 1200 GxP audits, Gap Analysis and remediation projects world-wide, with over 35 years, hands-on technical and management level experience within the Pharmaceutical, Biotechnology, Medical Device, Petrochemical, Validation, and regulated industries.

John has conducted hundreds of speaking engagements, seminars and bootcamp style training seminars world-wide.

Published, cosponsored and audit reviews of thousands of technical and professional papers, journals and books for hundreds of Companies in the regulated industry.

John has assisted hundreds of companies in meeting and exceeding regulatory compliance, pertaining to ‘for-cause’ or ‘due-diligence’ initiatives. Assisting companies to achieve, resolve, remediation and exceed regulated industry requirements, mandates, ‘for-cause’ and ‘due-diligence’ priorities with the technique of promoting GxP standards and practices through interactive hands-on training.

John has extensive knowledge in industry standards; FDA (CDER, CBER, CDRH, CVM, CFSAN), cGMP, GLP, ICH, OECD, GAMP, ISO, OECD, OSHA, HACCP, HIPPA, EPA and GCP regulations and thorough knowledge in the process of implementation of these standards.



































































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