Knowledge Box

Knowledge Box is a powerful technical resource for engineers delivering real results in problem-solving, quality, validation, compliance and process performance.

What Is Knowledge Box?

Knowledge Box is for professionals working in the medical device and pharmaceutical industries who require a flexible and tailored approach to training and upskilling.

Knowledge Box is for engineers and scientists who wish to develop and enhance their technical and compliance knowledge required to keep current within the life sciences industry.

Unlike face-to-face training, our products and services are available 24/7, on-demand and online.

Current courses offered are delivered over a 4 to 6 week period, providing flexible training to the participants and companies. Each training period is approximately 45 minutes of self-study concluding in examination and certification.

How Is the Training Rolled Out?

Courses are delivered through email with each candidate completing the content through self-learning.
Each training programme is made of the following elements:

• Between 4 and 6 self-learning sessions completed on a weekly basis.
• Technical tasks to be completed by the participant for each session.
• Upon completion of the programme, an open-book exam consisting of 30 multiple-choice questions.
• On successful completion of the course and exam, each candidate receives a certificate of completion.

Course Offerings: 2015-2016

Course	Duration
Process Validation for Medical Devices	5 weeks self-study (approx. 45min sessions x 5)
Engineering Principles for Biopharmaceutical Processes	4 weeks self-study (approx. 45min sessions x 4)
Clean-in-place for Pharmaceutical Processes	4 weeks self-study (approx. 45min sessions x 4)
GAMP for Engineers	4 weeks self-study (approx. 45min sessions x 4)
Cleaning Verification and Validation for Medical Devices	4 weeks self-study (approx. 45min sessions x 4)
Good Manufacturing Practices (GMP)	3 weeks self-study (approx. 45min sessions x 3)
Good Engineering Practices (GEP)	3 weeks self-study (approx. 45min sessions x 3)
Good Documentation Practices (GDP)	3 weeks self-study (approx. 45min sessions x 3)
Risk Management for Engineers	4 weeks self-study (approx. 45min sessions x 4)
ISO 13485 – Quality Management System for Medical Devices	4 weeks self-study (approx. 45min sessions x 4)
21 CFR Part 211 (cGMP) and Eudralex V4 (GMP)	4 weeks self-study (approx. 45min sessions x 4)
21 CFR Part 11 Electronic Records	3 weeks self-study (approx. 45min sessions x 3)

What's Included in the Toolbox?

In addition to the programmes listed on the previous pages, Knowledge Box has practical tools and templates that a company or individual can utilise on a daily basis.

Your online toolbox includes:

Resource	Type
Equipment Installation and Operational Qualification Protocol Template	Template
Factory Acceptance Test (FAT) Protocol	Template
User Requirements Specification (URS) Template	Template
Validation Master Plan Template	Template
6 Step Root Cause Analysis	Tool
PDCA tool	Tool
Corrective and Preventative Action Tool	Tool
Communication’s Board toolbox	Tool
6M Problem Solver	Tool
DMAIC Tool	Tool
5S	Tool
FMEA	Tool
Kanban	Tool
Poke Yoke	Tool
Equipment Qualification Guide	Guide
Good Documentation Practices Guide	Guide
Good Manufacturing Practices Guide	Guide
Process Validation Guide	Guide
Test Method Validation for Medical Devices	Guide
Risk Management- An Introduction	Guide
CGXP and Validation for Engineers	Guide
ISO 13485- QMS for Medical Devices	Guide
Cleaning Verification and Validation -Introduction	Guide

Pricing Plans

• Remember, all corporate packages include unlimited programme access for each person subscribed.
• Employees can complete any or indeed all programmes offered. Each programme concludes with assessment and certification.
• Each subscription also allows access to our online toolbox.
• A corporate package can be designed and delivered to meet specific requirements. Please contact us to discuss such requirements.