Template

List of Training Documentation

Sven Piechottka · ISO 13485 Templates · Published June 09, 2022

Template download

This is a free template, provided by OpenRegulatory. If you are a user of Formwork, our eQMS software, you can save time by choosing “QMS” on the top menu and “OpenRegulatory Templates” on the left menu, then opening the relevant folder to find this template ready to load into Formwork.

Using a different QMS? Download below as Word (.docx), PDF, Google Docs or Markdown. The template license applies (keep the copyright at the bottom, don’t re-use for commercial purposes).

Template preview

List of Training Documentation

This template is supposed to give you an idea of the structure. Don't use Microsoft Word - this is thought
as an Excel / sheets file.

Also, think of this as two tabs - one for initial and one for continuous training.

Initial Training

Employee Start of Employment Job Role Training #1: QMS Intro Date Due Date Completed Effectiveness Training #2: Data Privacy (...)
Jack Rack 01.04.2021 Sales Manager Applicable 15.04.2021 14.04.2021 Confirmed by supervisor Applicable

Continuous Training

Name of Training Type of Training Due Date Participant #1 Date Completed Effectiveness Check Participant #2 Date Completed (...)
Annual Data Privacy Training Recurring 01.04.2021 Applicable 14.04.2021 Confirmed by questionnaire Applicable 14.04.2021
Code of Conduct New SOP 01.05.2021 Applicable 03.05.2021 Confirmed by questionnaire Applicable 03.05.2021
Development Process Updated SOP 01.05.2021 N/A Applicable 03.05.2021

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Sven Piechottka

Sven Piechottka

With a background in political and administrative sciences, my way into regulatory affairs started from a different angle. I focused on the promises of precision medicine during my final year of studies and first joined IBM to help leverage healthcare innovation projects across Germany.

 I then gained most of my regulatory experience while working for Vara (before: Merantix Healthcare), where we built up a quality management system from scratch. For about three years, I coordinated regulatory affairs, led the ISO 13485 certification and CE certification of an AI-based radiology software, and served as data protection officer and quality management officer of the company.
More about me