SkillsPlus International - GMP Compliance Resources

Established almost 20 years ago, SkillsPlus International, the vision of Allan Dewes, president and CEO, is motivated to provide compliance resources that reach beyond the ordinary. SkillsPlus International meets the needs of the pharmaceutical, biotech and medical device industries. Professional training and distinctive training resources include current GMP information and regulatory guidance in support of attaining the client’s quality and compliance goals.

With innovation, experience and quality as the foundation of the SkillsPlus International team, a wide range of GMP training products, services and educational tools serve a diverse client audience from several industries.

GMP computer-based training (CBT) and learning management systems (LMS)

Designed and developed unlike any other CBT resource, SkillsPlus’ training experts carefully explain and describe GMP concepts and FDA requirements with live-action content. Student attention is captured by inclusion of animated graphics and interesting video from production facilities. These courses serve as stand-alone training programs or as plug-ins to a client-owned learning management system (LMS).

SkillsPlus offers LMS hosting services for training according to the client’s schedule. Here the client functions as teacher or administrator, and technical support is available.

With SkillsPlus’ pay-per-view system individual learners can access CBT courses by purchasing single-access tickets online, and participate in training via the SkillsPlus LMS.

On-site classes, GMP courses and compliance training workshops

Our professional instructors deliver highly interactive GMP courses and compliance training workshops. With expertise gained from years of experience within the regulated industries, expertly designed courses address unique training and compliance needs. Customized program development is also available to address client-specific issues. Some of our most popular classes are:

• GMP Essentials
• Root Cause Analysis for Better Investigations
• Writing Deviation Investigations
• Writing More Effective Procedures
• GMP Olympics
• Executive Session GMPs
• Training Skills for Trainers
• Creating GMP Accountability and Responsibility

GMP public seminars

Offered in the United States and internationally, public seminars focus on new skill acquisition, performance improvement and application of GMP to the daily work environment. Some of our most popular public seminars include GMP essentials for drug manufacturers, and GMP trainer certification.

Instructor guides

Client-led, in-house delivery of GMP and QSR training in pharmaceuticals, biotech and medical device is fast and easy with our prepared lesson plans in electronic format. Guides, with graphics, explain concepts clearly with examples, and activities and learning assessments are included. Most classes are 90 minutes long.

GMP computer-based activities (CBA)

Using an interactive format, these educational tools challenge, motivate and reinforce GMP training concepts.

• GMP Challenge – presents basic GMP questions and challenges teams to respond by beating the clock and other team responses; on-screen scoring raises the bar for the team competition, and questions and suggested responses are fully editable
• Inspection Detection – focuses on the justification for 483 observations; teams must identify the 21CFR211 subpart that supports the investigator’s observation; cases and subpart references appear on screen and are fully editable

Consulting services

Reflecting the latest in regulatory development, our consulting services focus on auditing for compliance, training needs assessment, SOP systems, procedure writing, custom program development, deviation investigations and report writing, procedure and controlled document writing, and special compliance projects.