E-learning Courses
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e-Learning Courses (self-serve downloads)
By SkillsPlus International Inc.

These products have been discontinued.

Welcome to SkillsPlus International Inc. E-learning. This page provides information about our computer-based E-learning training courses. E-learning has become the quickest way to complete required training at minimal cost.

E-learning & Online CBT Courses
21CFR211: Pure, Safe and Effective Equipment C GMPs Overcoming Documentation Nightmare Understanding Validation
21CFR820: Essential Elements Materials and CGMPs Production and Process Controls Contamination Control
Buildings and Facilities Organization and Personnel Surviving and FDA Inspection Change Control

 

E-learning and Online Courses and Modules
Overcoming The Documentation Nightmare  - This program provides a most interesting review of proper documentation practices for both paper-based and electronic record environments. Allan brings to this program the dynamic presentation style clients have come to expect. Actual plant video engages the learner. Interactive and LMS versions include quizzes and a final exam.

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  Time   Movie Interactive LMS
60 Min   $175 $200 $225

 

21 CFR 211: Pure, Safe, and Effective  - This program reviews 21 CFR 211 with the reminder that all these rules help us produce a product that is pure, safe and effective. This program is a must for new employee orientation training at all levels of the organization.

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  Watch Free Preview Clip   Time   Movie Interactive LMS
51 Min   $300 $325 $350

 

21 CFR 820: Essential Elements  - This program reviews 21 CFR 820 from inside a medical device manufacturing facility. Learn the rules affecting medical device manufacturing while getting a glimpse of medical device production techniques.

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  Time   Movie Interactive LMS
66 Min   $300 $325 $350

 

Buildings and Facilities  - This topic provides a review of the requirements of Building and Facilities issues well beyond Subpart C, Buildings and Facilities.  This program, uses many video segments from actual plant operations to review the essential elements of this Subpart.

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  Watch Free Preview Clip   Time   Movie Interactive LMS
157 Min   $300 $325 $350

 

Surviving an FDA Inspection  - Learn what to expect, how to plan for an inspection, and how to behave. This program has demonstrations of interviews and different response strategies. Some are intended to be humorous, while some are common mistakes made when interacting with the FDA. Use this program to plan for your next inspection.

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  Watch Free Preview Clip   Time   Movie Interactive LMS
160 Min   $300 $325 $350

 

Understanding Validation  - Delve into the intricate rules and practices of validation. This course is based on guidance documents on validation. The concepts of validation are explained in simple language. This is a great introduction to validation as well as preparation for the plant's next major validation initiative.

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  Watch Free Preview Clip   Time   Movie Interactive LMS
73 Min   $300 $325 $350

 

Contamination Control  - This topic discusses the sources of contamination and methods to prevent contaminating products. This is a great session for new employees needing to learn about the risks and proper behaviors to controlling contamination. Use this program as part of a corrective or preventive action as a result of contamination control breaches.

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  Watch Free Preview Clip   Time   Movie Interactive LMS
46 Min   $300 $325 $350

 

Equipment and CGMPs  - This topic discusses the requirements of 21 CFR211 Subpart D - Equipment, specifically the design and construction requirements for equipment including lubrication and coolants. The class addresses cleaning and maintenance requirements including automatic and electronic equipment. The class also covers the requirements for equipment identification, personnel training, and required documentation.

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  Watch Free Preview Clip   Time   Movie Interactive LMS
46 Min   $300 $325 $350

 

Materials and CGMP  This topic traces the CGMP requirements from supplier qualification through to manufacturing and packaging. A solid review of 21 CFR 211 Subpart E, Control of Components, Drug Product Containers and Closures.

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  Watch Free Preview Clip   Time   Movie Interactive LMS
46 Min   $300 $325 $350

 

Organization and Personnel  This topic summarizes the essential elements of 21CFR211 Subpart B, Organization and Personnel. This is a great orientation to this subpart for new employees or serves as a quick refresher.

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  Watch Free Preview Clip   Time   Movie Interactive LMS
46 Min   $100 $125 $150

 

Production and Process Control  This topic provides a review of the requirements of 21 CFR 211 Subpart F, Production and Process Controls.  This program, uses many video segments from actual plant operations to review the essential elements of this Subpart.

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  Watch Free Preview Clip   Time   Movie Interactive LMS
46 Min   $125 $150 $175

 

 

Implementing A Successful Change Control Program - This program reviews the requirements of change control and components of a successful change control program.

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    Watch Free Preview Clip Time   Movie Interactive LMS
35 Min   $125 $150 $175
 

 

 

Features

  •   Movie versions

  •   E-learning interactive versions

  •   Play from a PC

  •   Play from corporate Intranet

  •   Learning Management System plug ins are AICC or SCORM compliant

  •   Classes designed by Allan Dewes and Jackie O'Neill, internationally known compliance instructors

  •   View topics list

Benefits
  • Use in the classroom as a training video

  • Standardize content delivery

  • Reduce training expense with E-learning

  • Use in one-on-one training environments

  • Make these classes a part of corrective and preventive actions

  • No user license fees (except for use in the SkillsPlus International Inc. LMS)

  • Use in the classroom as a training video to standardize delivery

1 Times are estimates and vary depending on the speed of taking the course assessments. Quiz questions are presented twice (once for practice, and once for the final exam). Quiz times are estimated by 0.75 minutes for each question. Individual student response times may vary.

For a prompt reply to requests and questions:  415.948.5220 |  skillsplus@aol.com 

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