GMP Boot Camps
FREE*
8-hour GMP, QMS & 21 CFR Part 11 Training
*A $29.95 fee will be charged to ensure against 'No-Show' Registrations. Also includes registration, e-Workbook & e-Certificate**
13th November 2024
Next Training:
Registration plus Paper Certificate & GMP Handbook!
$39.95 + $10.00 FedEx Shipping. Continental U.S. Only
We will register your Seat and Ship the Paper Gold Seal Certificate of Attendance & the Standard GMP Handbook to your Door post training. Currently only available for U.S. Customers
* Currently Only Available to U.S. Shipping.
For International Shipping click here
Personalized Interactive 8-Hour GMP Training
On-site Seminars / Webinars
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Basic GMP/QMS/Part 11 101 8-hour
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Medical Device - ISO 13485
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Cosmetics CGMPs
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21 CFR Part 11-Validation
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Good Laboratory Practice
Training includes:
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GXP Handbooks
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Workbook Binders
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Certificate of Attendance
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Q&A Sessions
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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:
Full Presentation - $495.00
Includes (*US Customers Only):
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*GMP International Handbook
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GMP e-Workbook
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Slide show Presentation
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*Paper Certificate of Attendance
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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:
1. Choosing the Number of Training Days
Select the Base Daily Rate for Trainer SME, then Purchase Training Materials, Workbooks, Handbooks & Certificates
2. Purchase the Number of Workbooks, Handbooks and Paper Certificates
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Customize training specific for Products or Services.
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Add on-site Audit prior to Training, utilizing your audit observations as part of the training.
**Certificate of Attendance will only be issued upon verification of attendance through the GoToWebinar Analytics software
The Course Curriculum
Course Agenda
GMP QMS 101 The Basics - The required GMP Training for all employees who work in regulated industry.
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GMP and the GMP Focus and the GMP Lifestyle
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The Predicate Rules
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The FDA Agency, Inspections, Warning letters and 483s
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Quality Terminology
The Quality Management System (QMS)
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The Basics of QMS
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CAPA - The basics about Corrective and Preventive Actions;
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Non-Conformance - Materials Supply, Specifications and Quality;
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Change Control - Documentation, Engineering, Production and Distribution;
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Deviations - Deviation management essentials;
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Out of Specifications / Out of Trend - Management of OOS and OOT;
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Complaints - Receipt, Qualifications, Risk Assessments and Remediation/Resolution;
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Recalls - The process, and indications of failures;
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Product Traceability;
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Audit - Internal, Agency, Customers and External Audit;
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Vendors, Suppliers and Contractors - Quality Agreements;
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The Meetings - Management and Quality Meetings;
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The 11 General Orders / Principals of GMP
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Writing Procedures (with template examples);
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Following Procedures (and the failures that occur);
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Documentation (Requirements, and the Regulations);
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Validation (Concepts, and basic process requirements);
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Design/Build Facilities and Equipment (In-depth look into a GMP facility requirement);
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Maintain Facilities and Equipment (Maintenance, Calibration, Use and Cleaning of Facilities/Equipment);
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Competency (The Training Requirements);
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Sanitation and Good Housekeeping Practices (General requirements for all facilities);
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Control for Quality (from Materials Receipt, Production, Packaging and Distribution);
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Audit Requirements
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Prepare for Battle! The Traceability Process;
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21 CFR Part 11 Electronic Records
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21 CFR Part 11 Basic Overview
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Definitions, System Types and Classifications
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21 CFR Part 11 – Predicate Rule
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Part 11.10 Sections a) - k)
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