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GMP Boot Camps

FREE* 8-Hour GMP, QMS & 21 CFR Part 11 Training
14th May, 2024

Discount Seat Packages

*This is a Webinar. Due to limited seats a $29.95 fee will be charged to ensure against 'No-Show' Registrations.  

**Fee includes e-Workbook and the e-Certificate of Attendance***. 

Personalized Interactive 8-Hour GMP Training
On-site Seminars / Webinars
  • Basic GMP/QMS/Part 11 101 8-hour

  • Pharmaceutical CGMPs with API

  • Medical Device - ISO 13485

  • Cosmetics CGMPs

  • 21 CFR Part 11-Validation

  • Good Laboratory Practice

Training includes:

  • GXP Handbooks

  • Workbook Binders

  • Certificate of Attendance

  • Q&A Sessions

  • Access to GMP Helpdesk

Video Recording - $2,995.00

4 Segment Session Edited

TEAMs, or  GoToWebinar Webinar Training. Video Recording - 1,995.00

Includes Handbooks, Workbook Binders, & Certificates for Attendees:
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**Certificate of Attendance will only be issued upon verification of attendance through the GoToWebinar Analytics software

Full Presentation - $495.00

Includes:

  • GMP e-Workbook

  • Slide show Presentation

  • e-Certificate of Attendance

  • 14 Day Recording Access

Training programs available:

Additional Training Courses Available at
GMP Boot Camps and The Auditing Group, Inc:

 1, 2, or 3-days On-site or TEAMS Webinar Programs:

The Course Curriculum

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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

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