OUR PRODUCTS
Self Paced/Computer Based GMP Basic 12 Pack Training Modules
$3600.00 for the entire set of Flat Rate/ready to go modules or $325.00 per module
(no tax, free shipping/handling)
The 12 Pack Basic Modules are offered as self-paced computer training power point programs that advance and contain a voice over for each slide (no instructor needed). Self-paced modules allow for pausing of program and advancing or reversing slides to repeat audio. For individual use or group presentations. All modules are 20 to 45 minutes in length. Quiz for each module is included and site license.
The Twelve Pack Modules cover a comprehensive overview of the GMP regulations. Ideal for Employee Orientation and on-going GMP training.
GMP Basic 12 Pack Self-Paced Set
12 Basic GMP Modules, 12 quizzes and answer keys, a site license
Module 001 The History of Good Manufacturing Practice (GMP’s)
Module 002 Principles for Operating in a GMP “State of Control”
Module 003 Laws, Regulations and Guidelines
Module 004 GMP's and Written Procedures
Module 005 Examination of the Pharmaceutical GMP Regulation Subparts
Module 006 Discussion of Equipment and Facility Control Requirements
Module 007 Your Personal Responsibilities to the GMP regulations
Module 008 Preventing and Controlling Against Contamination
Module 009 Details of a Comprehensive Pest Control Program
Module 010 A Look at Internal and Self Conducted Audits
Module 011 Good Documentation Practices
Module 012 Understanding the FDA Systems Based Inspection Technique
Self Paced/Computer Based GMP Advanced 6 Pack Training Modules
$2500.00 for the entire set of Flat Rate/ready to go modules or $450.00 per module
(no tax, free shipping/handling)
GMP Advanced 6 Pack Self-Paced Set
6 Advanced GMP Modules, 6 quizzes and answer keys, a site license
Advanced GMP Training - Module 101 – The Quality System
Advanced GMP Training - Module 102 – The Production System
Advanced GMP Training - Module 103 – The Material System
Advanced GMP Training - Module 104 – The Equipment and Facility System
Advanced GMP Training - Module 105 – The Packaging and Labeling
Advanced GMP Training - Module 106 – Laboratory Controls
Call us at 859-380-4847 for more self-paced module content details
All Basic 12 Pack Modules are also available as web-based/on-line training.
Call for web based pricing.
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Instructor-Led GMP Basic 12 Pack Training Modules
$4500.00 for the entire set or $399.00 per individual module (no tax, free shipping/handling)
Our GMP instructor lead training modules are ready to be used by your internal trainers, supervisors, group leaders, managers, or anyone in your company who want to do live GMP training. Modules are designed to be delivered in 15 to 45 minute segments and are ideal for monthly GMP training sessions. The 12 module titles are the same titles and content as the GMP Basic 12 Pack Self-Paced/Computer Based Modules.
The Basic 12 Pack Instructor Lead Modules contain: (all in customizable formats)
- A PowerPoint presentation for each module, a total of 376 slides
- Instructor's notes for each slide (a script to follow)
- Handouts for participants to follow along
- A quiz to test learning and retention for each program and answer keys
The Twelve Modules cover a comprehensive overview of the GMP regulations.
Module 001 The History of Good Manufacturing Practice (GMP’s)
Module 002 Principles for Operating in a GMP “State of Control”
Module 003 Laws, Regulations and Guidelines
Module 004 GMP's and Written Procedures
Module 005 Examination of the Pharmaceutical GMP Regulation Subparts
Module 006 Discussion of Equipment and Facility Control Requirements
Module 007 Your Personal Responsibilities to the GMP regulations
Module 008 Preventing and Controlling Against Contamination
Module 009 Details of a Comprehensive Pest Control Program
Module 010 A Look at Internal and Self Conducted Audits
Module 011 Good Documentation Practices
Module 012 Understanding the FDA Systems Based Inspection Technique
Instructor-Led GMP Advanced 6 Pack Training Modules
$3,500.00 for the entire set or $597.00 per module (no tax, free shipping/handling)
The GMP Advanced 6 Pack instructor-led training modules come on CD.
Our GMP instructor-lead 6 Pack Advanced training modules are ready to be used by your internal trainers, supervisors, group leaders, managers, anyone who would like to present GMP training. They have been designed to be delivered as 35 to 55 minute programs.
The Advanced 6 Pack Modules contain over 240 PowerPoint slides, 80 pages of handouts, and 6 quizzes and answer keys, and an instructor script for each module.
Advanced GMP Training - Module 101 – The Quality System
Advanced GMP Training - Module 102 – The Production System
Advanced GMP Training - Module 103 – The Material System
Advanced GMP Training - Module 104 – The Equipment and Facility System
Advanced GMP Training - Module 105 – The Packaging and Labeling
Advanced GMP Training - Module 106 – Laboratory Controls
Call 859-380-4847 for more instructor-led module content details
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We also sell generic SOP’s and a Quality Manual
(cost of entire set is $2600)
Quality Manual (QSP 001) and Master SOP (DOC 001) are $197.00 each.
All other documents cost $147.00 each.
QSP 001 Quality Manual
This manual is the Quality Manual which sets forth quality policies, objectives, and management responsibilities, in addition to providing an overview of the policies and philosophies associated with each element of the Quality System. The specific details on how these policies and philosophies are implemented, maintained, and controlled are presented in the SOP Procedures Manual and the Work Instructions and Test Method Manuals.
QSP 002 Quality Control Unit Responsibilities
This procedure details the responsibilities and activities carried out by a Quality representative.
QSP 003 GMP and Technical Training
The purpose of this SOP is to define and formalize the procedure for training employees under GMP guidelines regarding GMP and Technical Training (Includes Form QSP 003-F1)
QSP 004 SOP Training
This procedure defines the steps for training employees in SOP's. (Includes Form QSP 004 – F1)
QSP 005 Internal Audit Program
The purpose of this procedure is to define the process for performing internal audits.
QSP 006 Personnel Responsibilities
The purpose of this SOP is to ensure that all personnel that may or come in contact with a product or its component or its environment are healthy, clean, and attired appropriately.
QSP 007 Equipment Cleaning and Use Log
To define Equipment Use and Cleaning Log Records. (Includes Form QSP 007- F1)
QSP 008 Nonconforming Products
This procedure identifies plans to comply with the specified requirements of our quality management system and controls Nonconforming Product, and to set standards for operation.
QSP 009 Corrective Action/Preventive Action
This procedure defines the steps required to take corrective and preventive action to control out of specification results and non-conformances. (Includes Form QSP 009- F1)
QSP 010 Returned Goods
This procedure describes the activities needed to document and address returned products.
QSP 011 Complaint Handling Procedure
This SOP defines the procedure for handling all telephone inquiries and written correspondence received from customers or consumers that may involve product quality. (Includes Form QSP 011- F1)
QSP 012 Recall Procedure
This SOP will define the procedures to be used to implement a recall, withdrawal or stock recovery.
QSP 013 Deviations
The purpose of this procedure is to define the activities for planned and unplanned deviations that occur.
QSP 014 Change Control System
The purpose of this procedure is to define the process for reviewing a change to equipment, software and facilities to determine the impact of a change.
QSP 015 Pest and Contamination Control
The purpose of this SOP is to define the procedures to be used to prevent rodents, insects and other pests from entering the building.
DOC 001 Master SOP
This SOP is written to document and define the formal procedure that personnel must follow when writing, reviewing, approving, training and implementing procedures.
DOC 002 Good Documentation Practices
This procedure defines the record keeping requirements to ensure that accurate, neat and legible manufacturing records are maintained.
DOC 003 Signature and Initial Log Procedure
The purpose of this procedure is to standardize, control and provide traceability and authorization for employee use of initials. (Includes Form DOC 003 – F1)
DOC 004 Record Retention
This procedure details record retention requirements.