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Welcome to the State of TMF podcast. From providing insights on how to improve inspection readiness, to identifying and scaling optimization programs that work, to training your team to operate at scale–you'll understand everything it takes to create a world-class TMF program. As subscribers, you'll learn how to take your TMF process and strategy to the next level. Through interviews, AMAs, and invite-only events, we give you a sneak peek into the data-backed insights we're executing for TMF ...
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ENCONA is an internationally operating business training, consulting, auditing, and technology firm. We're a boutique operation with a global network, and we like to think BIG. Our headquarters are based in Canada, and our footprint extends to associated companies and branch offices in Germany, Romania, the USA, South Africa, and Taiwan. Over 500 companies in more than 40 countries trust our professional business ethics and competence. Our ACADEMY offers classroom learning, digital instructo ...
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Employing an outside company to handle all payroll-related duties is known as outsourcing payroll services in a business. The main reasons for using payroll management services are to cut costs and free up time when handling payroll-related financial operations. Employing a third party to handle payroll operations frees up a company from having to recruit and educate a sizable in-house payroll team, buy suitable payroll software, and keep up with complicated tax regulations. All business typ ...
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Leaving No Stone Unturned: The TMFer’s Guide to Audit Trail Reviews
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Audit trail reviews may be a hot topic in the world of TMF right now, but that doesn't mean people know how to do them the right way. In this episode of The State of TMF, our experts will explain everything you need to know about audit trail reviews. We'll be going over the basics of audit trail reviews, the "why" and "how" of routine ATRs, which h…
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Finding Flexibility in a Framework: How to Build an Adaptive TMF Index for Any Study
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It's important to have standards—especially when it comes to the TMF index. Aligning your TMF index to the CDISC TMF Reference Model makes it easy for organizations to speak the same language, helps you breeze through M&As, and streamlines system migrations. In this episode of the State of TMF, our host Oliver Pearce will be joined by guest Anne Ac…
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Cracking the TMF Culture Code: Building Champions & Getting Non-TMF’ers engaged
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56:30
If the TMF is the cornerstone of a clinical trial, then why do so many TMFers find themselves having to convince others of its importance? The answer: culture. In this episode, we crack the TMF culture code and explain how you can get stakeholder buy-in, keep non-TMFers engaged, and ensure that everyone is doing their part. Our experts will discuss…
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Crafting a TMF Training Program for your Team
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We kicked off 2024 with our most popular State of TMF episode yet! Loads of you turned up to last week to learn more about TMF training—and how to do it right. Not only did our hosts share their foolproof 5-step formula for crafting an effective TMF training program for your team, but they also got real about some of the training struggles they've …
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Risk-based TMF management is set to be all the rage in 2024, and we want to help you hit the ground running. On the latest episode of The State of TMF, our experts shared their innovative and unique approach to risk-based TMF. They were also be joined by InSeption Group's EVP of QA & Compliance, Dawn Niccum, to discuss the past, present and what al…
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Trackers & Logs in the TMF: Where to file them?
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Trackers and logs are a notorious source of confusion in the TMF. But fear not, because our experts joined forces to discuss exactly where you should be filing trackers and logs in your TMF. They also shared a real (scary) story about what happens when an inspector asks to see a log that wasn't maintained 😱 and how you can avoid this happening to y…
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TMF Tell-all: Unveiling the State of TMF Annual Industry Report 2023
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Our experts sat down to discuss the unexpected findings from our first-ever industry report and graced us with some non-stop fire insights about the TMF world of today, and tomorrow. It was the perfect way to kick off the second season of The State of TMF. Subscribe to The State of TMF Live Events -> https://hubs.ly/Q01Hy0NW0 Join our community -> …
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What is VDA 2 & How Can You Reduce Testing Efforts With It?
1:12:54
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VDA Volume 2 “Quality Assurance for Supplies” describes the basic requirements for sampling of serial parts submission for automotive serial parts. As an integral part of quality planning, the standard regulates the correct submission of all relevant documents and parts to the customer. This ensures that the customer's expectations are understood a…
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Inspection readiness toolset - What tech do we need for the future?
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On the final episode of Season 1 of The State of TMF, our panel of experts did a deep dive into the tools you need to be inspection-ready—today AND tomorrow. Our host, Oliver Pearce, was joined by Paul Fenton and Donatella Ballerini from Montrium, and Jamie Toth from BeiGene. Subscribe to The State of TMF Live Events -> https://hubs.ly/Q01Hy0NW0 Jo…
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Is eTMF tech working for small companies?
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In this "food for thought" episode, our panel of experts explored the challenges presented by the eTMF technology currently available in the life sciences industry. Paul, Christina, and Oliver offered practical and actionable recommendations that small companies can take when implementing an eTMF system. Subscribe to The State of TMF Live Events ->…
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Once Upon a TMF: Boosting Inspection Readiness with Storyboarding
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In this insightful session, Oliver Pearce and Donatella Ballerini reveal how storyboarding can become your secret weapon in boosting confidence when it comes to the inspection readiness of your TMF. Subscribe to The State of TMF Live Events -> https://hubs.ly/Q01Hy0NW0 Join The State of TMF Community to keep learning -> https://hubs.ly/Q01DJHnL0…
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Lights, Camera, Inspection: Performing Oscar-Worthy Mock Inspections
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In this episode, experts Oliver Pearce and Christina Mantzioros turn the spotlight on the undeniable benefits of mock inspections, with actionable insights to put them into play and bolster your inspection readiness success from here on out. Subscribe to The State of TMF Live Events -> https://hubs.ly/Q01Hy0NW0 Join The State of TMF Community to ke…
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The New Inspection Frontier - Navigating Remote & Hybrid GCP Inspections
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In this riveting episode, our panel of experts took a deep dive into the evolving world of remote and hybrid inspections, and offered their best tips for how to be better prepared for this new reality. Featuring Paul Fenton of Montrium, Joanne Malia of Regeneron, and David Ives of Daelight Solutions Subscribe to The State of TMF Live Events -> http…
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Set Yourself up for Inspection Success: Leveraging TMF Health Checks & Oversight
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56:55
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The State of TMF is BACK, and in this episode, our experts will be discussing how to set yourself up for inspection success with TMF health checks and oversight. You'll come away with practical tips and actionable insights to help you maximize your inspection readiness. Sound interesting? Then listen now! Subscribe to The State of TMF Live Events -…
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Future of Payroll outsourcing: Payroll trends in 2023
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Payroll management has come a long way from manually calculating salaries and keeping records to an automated process that is streamlined, efficient and accurate. As technology continues to evolve, the future of payroll outsourcing looks promising with new trends emerging to enhance the process further. In 2023, we can expect to see more businesses…
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Employing an outside company to handle all payroll-related duties is known as outsourcing payroll services in a business. The main reasons for using payroll management services are to cut costs and free up time when handling payroll-related financial operations. Employing a third party to handle payroll operations frees up a company from having to …
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Mergers, Acquisitions & Shelved Compounds: Dealing with TMFs with Steph Viscomi & Dawn Niccum
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In this episode, we'll be tackling the complex situations that can quickly turn into a TMF manager's nightmare: mergers, acquisitions, and shelved compounds. Your favourite host, Oliver Pearce, will be joined by expert guests Steph Viscomi and Dawn Niccum to discuss how to navigate these processes without losing too much sleep. Subscribe to The Sta…
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Numbers don't lie - Building a TMF Metrics Program from the Ground Up
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48:45
Metrics, metrics, metrics. Despite metrics being one of the most popular topics in the world of TMF, there's still a fair bit of confusion about what they entail and how to leverage them correctly. We'll be tackling this confusion head-on and addressing some of the most prominent knowledge gaps when it comes to metrics in the third episode of The S…
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You've got mail - Building an intuitive process for TMF correspondence.
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TMF correspondence can be tricky. Have you ever found yourself asking what to keep, what not to keep, and where to keep it? Well, you're not alone. These are all perfectly normal questions that come up often when managing a TMF. In this episode, you'll learn how to properly manage TMF correspondence and how to put in place a process that your team …
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Confessions of an Ex-TMF Manager - Breaking Bad Habits with Note to Files.
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To file or note to file? That is the question. And it's one that continues to plague TMF professionals of all levels of experience. In this episode, we'll be discussing the dos and don'ts of writing note to files (NTFs) and how to develop a process that builds confidence in an inspection instead of undermining it. Join us for our very first episode…
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ENCONA hosted a free webinar on 2 March 2023. VDA 6.3, the globally recognized and established process audit standard, was published for the first time in 1998 and was revised in 2010, 2016 as well as 2022. In this completely free 1-hour webinar we will touch on the core changes, and update you about key requirements for updating auditor certificat…
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How To Effectively Audit Customer Specific Requirements
1:23:52
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ENCONA hosted a free webinar on 30 November 2022. Customer-specific requirements are the requirements created by the customer with the expectation that the supplier will identify, implement, and audit these customer-specific requirements with the same intensity that they do the basic requirements of industry standards such as IATF 16949:2016 - cust…
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ENCONA Interviewed on Punct Si De La Capat By Onelia Pescaru
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On Friday 28 October 2022 part of the ENCONA senior management team, Hans Trunkenpolz (Founder & Chairman of the Board), Lloyd Staples (Chief Executive Officer) and Dan Kulcsar (Romania Operations Manager), were interviewed on Punct Si De La Capat By Onelia Pescaru, on Nova Tv Brasov. Learn more about what makes us tick and our expansion into the R…
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What Is This TISAX® Thing Everyone Is Talking About?
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On Wednesday 21 September 2022 ENCONA hosted a free webinar. Established in early 2017, the TISAX® testing and exchange mechanism was founded on the German Association of the Automotive Industry (VDA) catalog of ISA (Information Security Assessment) requirements, largely established on the basis of the international ISO/IEC 27001 standard. The plat…
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How to Effectively Identify, Gain & Maintain Organizational Knowledge (according to IATF 16949:2016)
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ENCONA hosted a free webinar on 31 August 2022. There is a need to determine and manage organizational knowledge, to ensure the smooth operation of processes, and to achieve conformity of products and services. Requirements regarding organizational knowledge were introduced to safeguard organizations from loss of knowledge due to staff turnover and…
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How To Implement An Effective Supplier Development Program (according to IATF 16949:2016)
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ENCONA hosted a free webinar on 13 July 2022, moderated by TARRYN JORDAAN, who was joined by subject matter experts HANS TRUNKENPOLZ and ANDREAS SCHRADER in an open discussion on this topic. Supplier development aims to provide an appropriate framework for improving the performance of suppliers as well as evaluating their performance. This webinar …
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Delivery Methods for Practical Digital Learning
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ENCONA ran a free webinar on 14 October 2020. This virtual roundtable focused on discussing the ideal delivery methods and media for practical and effective digital learning, including aspects such as engagement, accessibility, challenges and successes in remote learning. The webinar was hosted and moderated by Lloyd Staples, CEO of ENCONA, and the…
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What Is Emotional Intelligence and When Last Did You Check In With Yours?
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ENCONA's Director of People, KIRSTIN LISS (Industrial Psychologist), was interviewed on Tuesday 31 May 2022 on LinkFM in an open discussion on this topic. Kirstin is experienced in organizational development across various sectors focussing on the design and delivery of organizational development interventions including restructuring, executive lea…
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Leveraging Digital Productivity and Human Creativity To Drive Your i4.0 Strategy
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ENCONA ran a free webinar on 18 May 2021. THE TOPIC: LEVERAGING DIGITAL PRODUCTIVITY AND HUMAN CREATIVITY TO DRIVE YOUR i4.0 STRATEGY In this ever-evolving time of digitization, where questions about robots vs humans abound, we are left with no doubt as to the power of automating manual tasks, processes and workflows. However, the human mind is nec…
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What Does It Take To Implement Effective Enterprise Risk Management?
1:13:22
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ENCONA ran a free webinar on 13 April 2021. THE TOPIC: WHAT DOES IT TAKE TO IMPLEMENT EFFECTIVE ENTERPRISE RISK MANAGEMENT? We discussed risk assessment, mitigation, elimination and risk-based opportunities. This webinar refers to the ISO 9001 and IATF 16949:2016 regulations and whilst our examples may be based on the automotive industry, it is rel…
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How To Conduct An Effective RFMEA (Reverse Failure Mode & Effects Analysis)
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ENCONA hosted a free webinar on 17 May 2022, moderated by TARRYN JORDAAN, who was joined by subject matter experts HANS TRUNKENPOLZ and MARC SCHAEFFERS in an open discussion on this topic. Reverse FMEA is a structured process of continuous improvement that aims to ensure the permanent updating and progress of an FMEA (Failure Mode and Effect Analys…
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Are Management & Production Systems Efficient Without Emotional Intelligence?
1:23:27
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ENCONA hosted a free webinar on 1 September 2021, moderated by TARRYN JORDAAN (Marketing Manager), who was joined by subject matter experts KIRSTIN LISS (Industrial Psychologist) and HANS TRUNKENPOLZ (Founder & Board Chairman of ENCONA) in an open discussion on this topic. Kirstin is experienced in organizational development across various sectors …
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What Does It Take To Implement Effective Process Ownership?
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ENCONA ran a free #webinar on 2 March 2021 and the recording is available for you to watch & share. Since the IATF 16949 regulation was revised in 2016, the establishment of process ownership as a top management responsibility became a requirement for certification. We discussed what it takes to implement this requirement and answer pertinent quest…
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How To Conduct An Effective Management Review (according to IATF 16949:2016)
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ENCONA hosted a free webinar on 30 March 2022, moderated by TARRYN JORDAAN, who was joined by subject matter expert HANS TRUNKENPOLZ in an open discussion on this topic. Management review is the routine evaluation of whether management systems are performing as intended and producing the desired results as efficiently as possible. It is the ongoing…
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Supporting Successful Careers Despite Learning Disabilities
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ENCONA hosted a free webinar on Wednesday 1 December 2021. Natasja-Tez Brent (Peer Advocate & ENCONA Chief Operations Officer) was joined by Yota Baron (FORD Motor Company South Africa Chief Financial Officer) and Sharon Bruwer (Principal & Qualified SENCO at YHC POPS School & University) in this discussion, with Tarryn Jordaan (ENCONA Marketing Ma…
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Featuring Gregory Reh, DTTL Global Sector leader for life sciences and life sciences consulting leader for Deloitte Consulting LLP in the United States, and Jennifer Malatesta, advisory leader for life sciences for Deloitte & Touche LLP in the in the United States.By Deloitte Touche Tohmatsu
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Featuring Reynold W. (Pete) Mooney, DTTL Global Leader, Life Sciences & Health Care and Homi Kapadia, US Life Sciences Sector Leader.By Deloitte Touche Tohmatsu
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Featuring Reynold W. (Pete) Mooney, DTTL Global Leader, Life Sciences & Health Care and Homi Kapadia, US Life Sciences Sector Leader.By Deloitte Touche Tohmatsu
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Featuring Reynold W. (Pete) Mooney, DTTL Global Leader, Life Sciences & Health Care and Homi Kapadia, US Life Sciences Sector Leader.By Deloitte Touche Tohmatsu
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Part 2: Learn how accounting curriculums are changing to keep pace with the profession.By Deloitte Touche Tohmatsu
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Part 1: Learn how educators are helping their students get ready to enter the work force.By Deloitte Touche Tohmatsu
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By Deloitte Touche Tohmatsu
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Listen as Deloitte Life Sciences and Health Care leaders discuss themes from The Financial Times 2013 Pharmaceutical & Biotechnology Conference.By Deloitte Touche Tohmatsu
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Listen as the co-authors discuss hits, misses, and accuracy for 2013 predictions in technology, media & telecoms.By Deloitte Touche Tohmatsu
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Listen as Deloitte life science and health care industry leaders discuss topics from the Financial Times U.S. Healthcare and Life Sciences Conference 2013.By Deloitte Touche Tohmatsu
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Listen to Deloitte’s IFRS Insurance Lead Partners discussing, “The operating model implications for IFRS for insurance”.By Deloitte Touche Tohmatsu
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Listen in as the TMT Predictions 2013 provide an overview of Technology sector predictions for 2013.By Deloitte Touche Tohmatsu
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Have smartphones and tablets taken over, and is it the end of the PC? Listen in as the co-authors discuss this technology sector prediction for 2013.By Deloitte Touche Tohmatsu
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What are BYOC, or bring your own computer, policies and what does Deloitte predict for 2013? Listen as the co-authors discuss.By Deloitte Touche Tohmatsu
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Listen in as the co-authors discuss P@$$1234: the end of strong password-only security, a technology sector predictions for 2013.By Deloitte Touche Tohmatsu
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