---
title: eTMF Bootcamp On-Demand Sessions
description: Here's all of the recordings from the eTMF Bootcamp
---

[![montrium-logo](https://info.montrium.com/hs-fs/hubfs/montrium-logo.png?width=130&height=23&name=montrium-logo.png "montrium-logo")](https://info.montrium.com/)

# eTMF Bootcamp Series On-Demand

## Session 1

## TMF Fundamentals & TMF Management Best Practices

Hosted by Donatella Ballerini and Lindsay Curran from, this session covers the essentials of building and maintaining a compliant, inspection-ready TMF.

3 things you'll take away:

- **What makes a TMF inspection-ready**
- **How to use the TMF Reference Model**
- **Why a TMF plan is non-negotiable**

[Download the slide deck for Session 1](https://334618.hubspotpreview-na1.com/hubfs/eTMF%20Bootcamp%202022/Session%201-TMF%20Fundamentals%20An%20Introduction%20to%20TMF%20Management%20Best-Practices%20-%20eTMF%20Bootcamp%202022.pdf)

<iframe src="https://share.descript.com/embed/Zia7P0L9u95" width="100%" height="100%" frameborder="0" allowfullscreen></iframe>

## Session 2

## Master the Regulation: A Crash Course in TMF Regs, Standards & Models

In this session, we break down the regulatory landscape governing TMF management across the major health authorities, and what it means for your day-to-day processes.

3 things you'll take away:

- **The regulatory framework you need to know**
- **People are your biggest compliance risk**
- **Your eTMF must be purpose-built**

[Download the slide deck for Session 2](https://334618.hubspotpreview-na1.com/hubfs/eTMF%20Bootcamp%202022/Session%202-Master%20the%20Regulation%20-%20A%20Crash%20Course%20in%20TMF%20Regs%20-%20Standards%20%26%20Models%20-%20eTMF%20Bootcamp%202022.pdf)

<iframe src="https://share.descript.com/embed/5XBz8PAogUk" width="100%" height="100%" frameborder="0" allowfullscreen></iframe>

## Session 3

## TMF Fundamentals & TMF Management Best Practices

Hosted by Donatella Ballerini and Lindsay Curran from, this session covers the essentials of building and maintaining a compliant, inspection-ready TMF.

3 things you'll take away:

- **What makes a TMF inspection-ready**
- **How to use the TMF Reference Model**
- **Why a TMF plan is non-negotiable**

[Download the slide deck for Session 3](https://info.montrium.com/hubfs/6%20-%20Documents/eTMF%20Bootcamp%202022/Session%203-TMF%20Metrics%20101-What%20You%20Should%20Be%20Tracking%20and%20Why-eTMF%20Bootcamp%202022.pdf)

<iframe src="https://share.descript.com/embed/VOjeJPs5k9X" width="100%" height="100%" frameborder="0" allowfullscreen></iframe>

## Session 4

## Agile TMF: The Data-Driven TMF Process of the Future

Hosted by Donatella Ballerini and Paul Fenton (CEO, Montrium), this session challenges the industry's most persistent misconception about TMF and makes the case for a fundamentally different way of managing clinical documentation.

3 things you'll take away:

- **Your TMF is not an archive, stop treating it like one**
- **Manage the full document lifecycle inside your eTMF**
- **Your TMF is a goldmine of data**

[Download the slide deck for Session 4](https://info.montrium.com/hubfs/6%20-%20Documents/eTMF%20Bootcamp%202022/Session%204%20-%20Agile%20TMF%20-%20The%20Data-Driven%20TMF%20Process%20of%20the%20Future%20-%20eTMF%20Bootcamp%202022.pdf)

<iframe src="https://share.descript.com/embed/lQcxT7mU2aC" width="100%" height="100%" frameborder="0" allowfullscreen></iframe>

## Session 5

## TMF Migration Concierge: Using AI to Improve TMF Quality

Hosted by Paul Fenton (CEO, Montrium) and Mike Zvetko (Chief Innovation Officer, Montrium), this session closes out the Boot Camp series with a look at where TMF management is headed, and how AI is already changing the way teams index, review, and quality-check their documents.

3 things you'll take away:

- **How AI can do the heavy lifting on document indexing and QC**
- **Confidence scores and risk levels determine how much human oversight is needed**
- **AI turns your TMF into a data source, not just a document store**

[Download the slide deck for Session 5](https://info.montrium.com/hubfs/6%20-%20Documents/eTMF%20Bootcamp%202022/Session%205%20-%20A%20TMF%20Migration%20Concierge%20-%20Using%20Artificial%20Intelligence%20to%20Improve%20TMF%20Quality%20-%20eTMF%20Bootcamp%202022.pdf)

<iframe src="https://share.descript.com/embed/BLYU3tMYM4H" width="100%" height="100%" frameborder="0" allowfullscreen></iframe>

| ![](https://fast.wistia.com/embed/medias/azftk61x41/swatch) |  | ![](https://fast.wistia.com/embed/medias/djvjzy753g/swatch) |
| --- | --- | --- |
| [**Download slide deck for session 1**](https://info.montrium.com/hubfs/eTMF%20Bootcamp%202022/Session%201-TMF%20Fundamentals%20An%20Introduction%20to%20TMF%20Management%20Best-Practices%20-%20eTMF%20Bootcamp%202022.pdf) |  | [**Download slide deck for session 2**](https://info.montrium.com/hubfs/eTMF%20Bootcamp%202022/Session%202-Master%20the%20Regulation%20-%20A%20Crash%20Course%20in%20TMF%20Regs%20-%20Standards%20&%20Models%20-%20eTMF%20Bootcamp%202022.pdf) |
| ![](https://fast.wistia.com/embed/medias/d3lqd1y8ok/swatch) |  | ![](https://fast.wistia.com/embed/medias/iilsz339kj/swatch) |
| [**Download slide deck for session 3**](https://info.montrium.com/hubfs/6%20-%20Documents/eTMF%20Bootcamp%202022/Session%203-TMF%20Metrics%20101-What%20You%20Should%20Be%20Tracking%20and%20Why-eTMF%20Bootcamp%202022.pdf) |  | [**Download slide deck for session 4**](https://info.montrium.com/hubfs/6%20-%20Documents/eTMF%20Bootcamp%202022/Session%204%20-%20Agile%20TMF%20-%20The%20Data-Driven%20TMF%20Process%20of%20the%20Future%20-%20eTMF%20Bootcamp%202022.pdf) |
| ![](https://fast.wistia.com/embed/medias/miiu1rvz96/swatch) |  |  |
| [**Download slide deck for session 5**](https://info.montrium.com/hubfs/6%20-%20Documents/eTMF%20Bootcamp%202022/Session%205%20-%20A%20TMF%20Migration%20Concierge%20-%20Using%20Artificial%20Intelligence%20to%20Improve%20TMF%20Quality%20-%20eTMF%20Bootcamp%202022.pdf) |  |  |

 

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