SkillsPlus International Inc. - Computer Based Training Classes for GMP and QSR

Welcome to the SkillsPlus CBT training support center. This page provides information about our CBT training courses. Computer based training is the way to complete required training at minimal cost. Request a free preview of one of our program to decide if this approach is right for you.

Current List of Topics
Click the link below to learn more about each class.

21CFR211 Overview

Buildings and Facilities

Contamination Control

Equipment

Executive Session 2009

Materials and GMPs

Organization and Personnel

Production and Process Controls

Proper Documentation Practices

Root Cause Analysis

Surviving an FDA Inspection

Understanding Validation

Writing Procedures: Drug & Device Wholesalers & HMDRs

Effective Hand Washing - Coming Soon!

Writing Procedures - Coming Soon!

Features

Movie versions
CBT interactive versions
Play from CD/DVD
Play from corporate Intranet
View from the SkillsPlus Pay-Per-View site
Learning Management System plug ins are AICC or SCORM compliant
License to print student handouts
Classes designed by Allan Dewes and Jackie O'Neill, internationally known compliance instructors
View topics list
Download complete CBT course catalog (PDF)

Benefits

Use in the classroom as a training video
Standardize content delivery
Reduce training expense with CBT sessions
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 LMS)
Use in the classroom as a training video to standardize delivery

Pay-Per-View

Topics

Min¹

Outline

Movie

Inter-

active

LMS
Plug-In

Watch Now
Pay-Per-View

21 CFR 211 - This topic summarizes the most important elements of 21CFR211. This is a great orientation to the regulation for new employees or serves as a quick refresher for seasoned employees.
	35	Outline	$495	$695	$945	$49

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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.
	157	Outline	$1195	$1595	$1895	$99

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Contamination Control - This topic discusses the sources of contamination and methods of preventing contaminating products. This is a great session for new employees, or as part of a preventive action as a result of contamination control breaches.
	46	Outline	$625	$895	$1145	$49

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Equipment GMPs - 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.
	51	Outline	$695	$895	$1145	$99

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Executive Session - Explore the common observations issued from 2008 in a neatly organized pareto chart along with the regulatory agency expectations. Learn to identify common sources of observations and what are the expectations of regulatory agencies.
	115	Outline	$895	$1295	$1595	$99

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Materials and GMP - This topic traces the GMP 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.
	74	Outline	$995	$1395	$1645	$99

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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.
	37	Outline	$495	$695	$945	$49

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Production and Process Controls - 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.
	57	Outline	$525	$745	$1045	$49

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Proper Documentation Practices - This topic reviews the proper procedure for entering information into GMP documents, correcting errors in documents and highlights numerous acceptable documentation practices. This is a great class for new employees or others who need to review GMP documentation. It also serves as a retraining component as a part of a preventive action in response to a documentation deviation.
	49	Outline	$625	$895	$1145	$49

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Root Cause Analysis for Better Investigations - Having trouble resolving deviations? This topic reviews a successful model for investigating and identifying the root cause of deviations. This is a great review if you are considering our on site class on Root Cause Analysis.
	32	Outline	$785	$1095	$1345	$99

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Surviving and FDA Inspection - Learn what to expect, how to plan for an inspection, how to behave. This program has demonstrations of interviews and different response strategies.
	160	Outline	$1195	$1595	$1895	$99

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Understanding Validation - Delve into the intricate rules and practices of validation. This course is based on the 2008 guidance document on validation.
	73	Outline	$895	$1295	$1595	$99

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Writing Procedures: Drug and Device Wholesalers and HMDR's - Learn to write procedures quickly and thoroughly. Allan shares his experiences and techniques for writing procedures. This class is based on 30 years of experience writing procedures and teaching others to write them. This class is only for drug and device wholesalers, DME's and home medical device retailers. Pharmacists and pharmacy technicians responsible for procedures in their firm may also benefit.
	87	Outline	$1495	$1595	$1695	$250

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¹Time 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.

Contact us for a prompt reply!

Inquiry	Telephone	Email
Information via Email	(415) 487-3500	Click Here
Corporate and Consulting Services	(415) 487-3500	allan.dewes@skillsplusinc.com
Sales: Product and Services	(804) 938-4102	allan.dewes@skillsplusinc.com
Designated Representative - California Board of Pharmacy	(415) 487-3500	allan.dewes@skillsplusinc.com
Exemptee Certification - California Department of Health	(415) 487-3500	allan.dewes@skillsplusinc.com
Fax orders to	(415) 487-1926
Webmaster	(415) 487-3500	skillsplus@aol.com
Product and Service Support
On-line tech support for CBT classes		Click Here
On-line tech support for on-line purchases		Click Here
Live computer based training tech support	(415) 487-3500	Allan
Live GMP Content questions	(415) 487-3500	Allan or Jackie
Postal address	584 Castro Street #729	San Francisco, CA 94114

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Features

Benefits

Use in the classroom as a training video to standardize delivery

Top 1Time 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.

Top
¹Time 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.