The document discusses employee training and qualification management in regulated industries. It outlines FDA regulations requiring training for various personnel and describes approaches to competency management including awareness training, job training, and qualification of subject matter experts. It also discusses implementing an e-learning management system (ELMS) integrated with a document management system to track training records and facilitate knowledge sharing. Open-source options for an ELMS like Moodle and OpignoLMS are presented along with the Alfresco and Mayan document management systems.

1. info@hcderaad.nl
www.hcderaad.nl
Keeping Your Employees Knowledge Up
To Date and Qualification Management
Hans de Raad
Medetel 2016

2. info@hcderaad.nl
www.hcderaad.nl
Introduction
● OpenNovations
– Company of Hans de Raad
– Freelance, but not alone
● Specializations
– Open source and open standards in education,
government, healthcare
● Focus on:
– Information security, privacy, digital sustainability

3. info@hcderaad.nl
www.hcderaad.nl
Policy framework and GxP
● Companies/organisations in pharma are subject to
rules/regulations
– GxP, ISO 17025, ISO 27001,
Cfr 21 Part 11, etc
– Data management,
equipment/system
validation, etc
● Employee competence
management
– FDA guidelines for training

4. info@hcderaad.nl
www.hcderaad.nl
FDA regulations for employee
training
Regulation Regulated personnel
21 CFR 58.29 Non-clinical lab personnel
21 CFR 110.10 Human food handlers personnel
21 CFR 113.10 Thermally processed
food handlers
21 CFR 114.83 Acidified food-
processing handlers
21 CFR 120.13 HACCP systems manager
21 CFR 123.10 HACCP systems manager
21 CFR 211.25 Pharmaceutical personnel
21 CFR 225.10 Medicated feed personnel
21 CFR 600.10 Biological products personnel
21 CFR 606.20 Blood component personnel
21 CFR 820.25 Medical device personnel
21 CFR 1271.170 Human tissue recovery
personnel

5. info@hcderaad.nl
www.hcderaad.nl
Competence management
● Types of training
– Awareness training
– Training per se
– Employee qualification
– Qualification of Subject
Matter Experts

6. info@hcderaad.nl
www.hcderaad.nl
Employee knowledge qualification
proces
● IQ/OQ/PQ? Equipment only?
– Installation Qualification
● Base SOP training
– Operational Qualification
● Independant task operation /
Structured On-the-Job Training
(SOJT)
– Performance Qualification
● Task operation under (normal) operational pressure

7. info@hcderaad.nl
www.hcderaad.nl
e-Learning
● Standard: SCORM
– Sharable Content Object Reference Model (SCORM)
● SCORM is a specification of the Advanced Distributed Learning (ADL)
Initiative from the Office of the United States Secretary of Defense.
– A collection of standards and specifications for web-based
electronic educational technology (also called e-learning).
– It defines communications between client side content and a
host system (called "the run-time environment"), which is
commonly supported by a learning management system.
– SCORM also defines how content may be packaged into a
transferable ZIP file called "Package Interchange Format.

8. info@hcderaad.nl
www.hcderaad.nl
Training on the job
● “Context aware” training
– In IT nowadays also facilitated by video instructions.
– In applications: context aware help functions
● Qualification management can be
difficult
– Ad hoc
– Difficult to ensure coherence in
knowledge sharing

9. info@hcderaad.nl
www.hcderaad.nl
User self-training / knowledge
sharing
● Comparable to agile development
– Instead of monolithic training procedures
– Iterative / agile training sessions
– Employees (SME's) train eachother
as soon as knowledge / materials
become available
● Continuous training (training
per se)

10. info@hcderaad.nl
www.hcderaad.nl
Employee qualification records
● e-Competence records
– “Formal exams”
– Regular ELMS dossiers are not that different from GxP
compliant qualification records
● Who has performed which training and passed?
● What happens when an employee leaves the
company?
– Sir Richard Branson:
● “Train people well enough so they can leave, treat them well
enough so they don't want to.”

11. info@hcderaad.nl
www.hcderaad.nl
Implementing an ELMS
● Comparable to implementing a DMS
– But with more interactivity and dossier building
● Qualification records
– 2 way information sharing
● Pro-active (trainings)
● Reactive (knowledge library)
– The system should support both
● Most ELMS are focussed on training functionality, not on
the library

12. info@hcderaad.nl
www.hcderaad.nl
Open source ELMS
● ELMS:
– Moodle
– OpignoLMS
● DMS integration:
– Alfresco DMS
– Mayan

13. info@hcderaad.nl
www.hcderaad.nl
Moodle

14. info@hcderaad.nl
www.hcderaad.nl
OpignoLMS

15. info@hcderaad.nl
www.hcderaad.nl
ELMS – DMS Integration
● ELMS – DMS integration
– Use the ELMS as courseware
– Use the DMS as library

16. info@hcderaad.nl
www.hcderaad.nl
Questions?
?

17. info@hcderaad.nl
www.hcderaad.nl
Contact
● Hans de Raad
– OpenNovations
– www.opennovations.nl
– E-mail: info@hcderaad.nl