Auditing and Validation Services for FDA Regulated Industry

Tel: 609-526-3464 - info@gmpbootcamps.com

   

 

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December 7th. FREE GMP QMS 8-Hour Webinar

Download the Brochure and Agenda

Standard On-Site 8-Hour GMP/QMS Bootcamps are available for $4,995.00!

*FREE Seat Registration

*Due to limited seats a $29.95 Registration Fee will be charged to ensure against 'No-Show' Registrations.

*The $29.95 Registration Fee will cover the 300+ Slide and e-Workbook. In addition, the **Certificate of Attendance.

DO NOT USE COUPON CODE IF YOU WANT
THE $29.95 PRESENTATION PACKET!

 
Full Presentation - $495.00
Includes:
  • PowerPoint Slide Show
  • GMP Workbook;
  • GMP Standard Handbook (Parts 11, 210/211, 820 & ICH Q7);
  • Certificate of Attendance;
  • 14 Day Recording Access;

Register for the September Webinar Here

Register Now

Register Full Packet Here

Select Date:
 
New Dates:
  - - Register for November 9
  - - Register for December 7
  - - Register for January 5
  - - Register for February 7
  - - Register for March 2
  - - Register for April 5
  - - Register for May 3
   

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!

Download the Brochure and Agenda

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

* Presentation and Certificates will be emailed
** Verification will be performed using GoToWebinar Analytics.

GMP Workbook

Course Agenda Download the Brochure and 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

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