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My Auditing Journey

Reading Scientific Services Ltd

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As any pharmaceutical quality professional will tell you, in an industry as tightly regulated as ours, audits are inevitable. Whether it’s an internal review by colleagues or external scrutiny from clients or regulators, successfully navigating these assessments is challenging but crucial. There may even come a time when you are called on to perform an audit yourself. With over 30 years of experience in the industry Pharmaceutical Quality expert Peter Deegan has been involved in his fair sha ...
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This is the final episode of this podcast. It includes: an explanation - why the podcast is coming to a close. snippets from a selection of prior episodes a brief introduction to Algorithm Integrity Matters - the new Risk Insights podcast. About this podcast The podcast for performance auditors and internal auditors that use (or want to use) data. …
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For our latest My Auditing Journey episode, our host Peter Deegan chats with RSSL Lead Auditor course alumni Sam Huff. Despite the fact Sam is early in his career, he has already accumulated an impressive amount of experience - and not all of it has been straightforward! Peter and Sam dive in to some of the tricky situations that Sam has found hims…
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This week we are joined by Wheeler Bio's Chief Quality and Regulatory Officer Marc Helouin! To say Marc has had a varied career would be an understatement. A trained Pharmaceutical Auditor with 25 years of Biopharma experience under his belt including Corporate Head of Audit (R&D) for AstraZeneca and leadership roles at other major pharma companies…
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Today we are joined by RSSL Head of Quality Peter Rooney! Starting in analytical chemistry, Peter's career has led him from running a contract lab to becoming a senior manager at UKAS, assessing against many different standards at labs large and small around the world before becoming the one responsible for getting RSSL into audit ready shape. The …
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This week Peter sits down with seasoned quality professional Clive Brading to discuss the insights he has gleaned across his varied career, culminating in leading a 50 strong auditing team for a global pharmaceutical company. Having years of experience organising and performing pharmaceutical audits Clive has been involved in his fair share of Phar…
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As a former Expert Lead of the MHRA GDP inspection team and with the wealth of 32 years of regulatory experience behind him, Tony Orme knows a thing or two about how the MHRA audit and the training that every MHRA inspector must complete. Across his years leading the most high profile and complex inspections, Tony has been involved in the developme…
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For our third episode Peter is joined by Lead Auditor Tutor and Practitioner Sue Mann. Sue has had a wide and varied career spanning many different companies and even continents. Starting as graduate pharmacist and swiftly progressing through to senior leadership roles in major pharma and consultancy, Sue has conducted countless audits in her caree…
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For his second episode in this series of conversations Peter is joined by highly experienced Qualified Person Graham Saunders to share insights he has gleaned across his rich and varied career. Graham has worked within some of the biggest Pharma companies around, covering commercial, IMP GMP's and API's. His auditing experience is equally as impres…
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For the first episode in our brand new series we are joined by RSSL Lead Auditing Tutor Adam Slater. Adam is a highly experienced auditor, with over 30 years experience in the Pharmaceutical GMP sector. His broad portfolio of auditing scopes and extensive work contract manufacturing, worldwide managing quality improvement programmes, improvement au…
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Embracing Internal Audit Evolution: A Conversation with Michael Drechnowicz, Head of Internal Audit at TK Elevator In this episode, Michael shares his insights on the evolution of IA in his role as Head of Internal Audit with a major player in the global elevator and escalator industry. His work demonstrates a shift from traditional finance-focus t…
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Our guest is Cathy O'Neil, author of Weapons of Math Destruction: how big data increases inequality and threatens democracy. Cathy joined us to discuss critical aspects for auditors to consider, including: The human element: why understanding 'for whom an algorithm might fail' is more important than the detailed technical design of an algorithm. Al…
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Maarit Widmann is a data scientist at KNIME (www.knime.com) In this episode, we discuss: What KNIME is Why the visual programming paradigm (workflows, rather than code) is appealing to both technical and non-technical professionals The most challenging aspects of the data science lifecycle, and what auditors should be aware of The most important as…
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In this episode we discuss the use of the word "analysis" in the context of using data for audits. This is an attempt to define the "analysis phase" - or stop using it as the name of a phase - so that we can better structure our work. This is explored in more depth in our book, here: https://riskinsights.com.au/the-data-confident-internal-auditor A…
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This episode is a pre-recorded interview with Benji Block for the Author Hour podcast. We discuss our new book, The Data-Confident Internal Auditor. For internal auditors, developing trends in data analysis and data science can feel less like a wealth of information and more like an avalanche. Still, better use of data provides an opportunity to ad…
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This is the fourth in a series of episodes that focus on performance auditing. In this episode, we discuss five suggestions to help improve the conduct (fieldwork / execution) phase. About this podcast The podcast for performance auditors and internal auditors that use (or want to use) data. Hosted by Conor McGarrity and Yusuf Moolla. Produced by R…
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This is the third in a series of episodes that focus on performance auditing. In this episode, we discuss the benefits of adopting a data focused approach during audit planning. About this podcast The podcast for performance auditors and internal auditors that use (or want to use) data. Hosted by Conor McGarrity and Yusuf Moolla. Produced by Risk I…
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This is the second of a series of episodes that focus on performance auditing. In this episode, we discuss the importance of balance in your work program - covering each of the four objectives: Effectiveness Efficiency Economy Compliance About this podcast The podcast for performance auditors and internal auditors that use (or want to use) data. Ho…
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This is the first of a series of episodes that focus on performance auditing. In this episode, we discuss strategic audit planning (a.k.a. forward work planning). For internal auditors, this is similar to annual (or equivalent) audit planning. Understanding your community / public expectations Understanding your elected body / parliamentarians Unde…
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In this episode we discuss three simple ways to improve the data cleansing process - easier, faster and higher quality. Find the optimal data source (e.g., don't use a poorly structured dataset) Cleanse iteratively - you may not need all of the fields/columns Import iteratively - start with a subset of the data and build on that as needed About thi…
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In this episode we discuss the use of risk/performance indicators. These can be used by audit teams, risk teams and integrity agencies. For audit teams, they are useful throughout the audit lifecycle - planning / risk assessment, fieldwork / conduct and reporting. We explore why they are useful, what to do and briefly how to get started. About this…
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Christine (performance audit) and Xiaoyan (data analytics) are Directors with ANAO, the Australian National Audit Office. In this episode we discuss: What The Australian National Audit Office (www.anao.gov.au) does The five ways ANAO uses data in its performance audits How performance audit teams work with the central data team Challenges with data…
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Tiina Landau is an internationally recognized sustainability expert and Certified European Financial Analyst (CEFA). She currently works as Sustainability Manager at Neste Corporation, embedding sustainability considerations into new business models and supply chains. She has extensive experience as a speaker in media and seminars and also writes a…
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Erica Toelle is a senior product marketing manager on the Microsoft compliance product team, with focus on information governance and records management. Erica is a long-time member of the SharePoint and Microsoft 365 community, a former Microsoft MVP, a published author, and a recognized expert in the information governance area. In this episode, …
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Michael DeCero is an Internal Audit Analytics Manager at TDS, a telecommunications company. In this episode, Michael explains how he helps his audit team use data. Links: Towards Data Science (www.linkedin.com/company/towards-data-science) Michael on LinkedIn (www.linkedin.com/in/michael-decero-39b95b44/) About this podcast The podcast for performa…
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Steve Rummel is a Senior Internal Audit Analytics Manager at CVS Health. In this episode, Steve explains how he helps his audit team use data. About this podcast The podcast for performance auditors and internal auditors that use (or want to use) data. Hosted by Conor McGarrity and Yusuf Moolla. Produced by Risk Insights (riskinsights.com.au).…
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Ari Levien is an experienced Chief Information Officer who has also played the role of Chief Risk Officer. In this episode we discuss how a CIO (with an understanding of risk) thinks about security and risk. We also discuss his views of Internal Audit and what good looks like for IA. About this podcast The podcast for performance auditors and inter…
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In using data for audits, quality assurance of our work is important. In this episode, we discuss: 1. The four main QA steps Technical QA Functional QA Business QA (validation) Audit QA 2. Why we need a QA Plan This is explored in more depth in our book, here: https://riskinsights.com.au/the-data-confident-internal-auditor About this podcast The po…
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In this episode, we discuss FIVE major benefits of investing our time in preparing our data and checking its quality. These include, in reverse order of importance: 1. Exploration during data prep to understand the data 2. Ensure the data is in the right format for analysis 3. Save time by avoiding incorrect conclusions 4. Confidence in the analysi…
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Morag (Senior Manager) and Gemma (Director) are Performance Auditors with Audit Scotland. In this episode we discuss how they are using data in their audits, their experience in developing Audit Scotland's data capabilities, collaboration with other audit offices and what the future roadmap looks like. We also discuss their focus on ensuring their …
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In this episode, we discuss why it is important to focus on our audit objective when using data analysis in our audit. We explore: Why a focus on the objective helps us measure success Why we should avoid rules based analysis How a focus on the objective helps us stay true to our audit mandate Cost benefit analysis when we find things that are not …
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Stephen leads the data science team within Performance Audit at VAGO, the Victorian Auditor General's Office. We discuss: What VAGO does Stephen's approach to helping auditors use data Why it's important for all performance auditors to have data skills How VAGO has used open data to improve transparency You can reach out to Stephen via LinkedIn (ww…
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Taka is the inaugural Chief Data Scientist at the US Government Accountability Office. He also leads the GAO's Innovation Lab. We discuss: What the GAO does How data science is helping GAO Innovation and experimentation at GAO Machine learning assurance You can reach out to Taka via the GAO website. About this podcast The podcast for performance au…
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In this episode, we discuss 10 of the more common areas of focus in using data for audits. Get over the fear of using data Focus on the objective and develop the hypotheses Check for previous work, to avoid duplication Source the data – internal and open Prepare the data and check quality Perform the analysis, prove/disprove the hypotheses Conduct …
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Note: This is a guest interview. Alli is an information design consultant and host of the Data Viz Today podcast. We talk about a range of data visualization matters, including 3 key mistakes that people make when starting out in dataviz (and solutions to those). You can reach out to Alli via her website (www.allitorban.com). Links Financial Times …
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In this episode we wrap up, talking about: a few things we've learned this year feedback - what people found valuable feedback - what people want to hear more about some of the tech/software used to produce this podcast About this podcast The podcast for performance auditors and internal auditors that use (or want to use) data. Hosted by Conor McGa…
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Note: This is a guest interview. John talks to us about what audit offices (a.k.a. supreme audit institutions) do and the role of the CTO in an audit focused organization. He shares his views on a range of issues including: His positive experience with their (outsourced) internal auditors How he supports an audit focused organization Cyber and data…
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Note: This is a guest interview. Andrew talks to us about machine learning (ML) and what auditors should consider regarding ML assurance. You can reach out to Andrew via the Monitaur website. About this podcast The podcast for performance auditors and internal auditors that use (or want to use) data. Hosted by Conor McGarrity and Yusuf Moolla. Prod…
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Note: This is a guest interview. David talks to us about IAC's latest report, the Talent Barometer and the upcoming Diversity report. He shares his views on a range of issues including: Data skill gaps Leadership skill gaps Why culture is important David is open to connecting with Internal Auditors. You can reach out to him on LinkedIn. Links David…
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In this episode we discuss how answering a few simple questions about your audience can improve your audit reporting. These help make several report areas better: Scope and title Context Findings / Improvement opps About this podcast The podcast for performance auditors and internal auditors that use (or want to use) data. Hosted by Conor McGarrity…
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Note: This is a guest interview. Carlos talks to us about what auditors should consider regarding cyber security and information security. He shares his views on a range of issues including: Cyber security How cyber security and information security differ What auditors should focus on in planning and conducting cyber audits Carlos is open to conne…
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In this episode we learn a bit about Yusuf, one of the co-hosts of the show. He explains what he considers to be the highlights of his career. About this podcast The podcast for performance auditors and internal auditors that use (or want to use) data. Hosted by Conor McGarrity and Yusuf Moolla. Produced by Risk Insights (riskinsights.com.au).…
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In this episode we discuss why discovery exercises are becoming very useful for audits. They help de-risk the conduct of audits, and the three main scenarios we use them for: Audit topic validation and overall audit planning Scoping, depth and deliverable Planning individual audits This is explored in more depth in our book, here: https://riskinsig…
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In this episode we explore Principle 3 - Maximize the Benefits of the use of data within Internal Audit and Performance Audit. Sub-principles 3a: Sharing lessons amongst the team. 3b: Identifying other risks and opportunities. 3c: Continuous improvement. This is explored in more depth in our book, here: https://riskinsights.com.au/the-data-confiden…
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Note: This is a guest interview. Josam Watson is the CRO of Tyme, a digital banking group that owns one of the world’s fastest growing digital banks. He was previously Chief Audit Executive of a large credit union. Before that, he spent time in internal audit, risk consulting, external audit and in banking operations. Josam talks to us about what h…
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In this episode we discuss four (4) approaches to using data for internal audits and performance audits: Reporting only Process focused Hypothesis-based Exploratory (a.k.a. data driven or data led) This is explored in more depth in our book, here: https://riskinsights.com.au/the-data-confident-internal-auditor About this podcast The podcast for per…
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In this episode we discuss six (6) sets of words and phrases that are commonly misused. Using data vs analytics Algorithm vs model Data owner vs data "custodian" AI vs machine learning Open source vs open data Big data vs big data About this podcast The podcast for performance auditors and internal auditors that use (or want to use) data. Hosted by…
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In this episode we learn a bit about Conor, one of the co-hosts of the show. He explains what inspires him to promote the use of data for integrity and assurance. About this podcast The podcast for performance auditors and internal auditors that use (or want to use) data. Hosted by Conor McGarrity and Yusuf Moolla. Produced by Risk Insights (riskin…
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In this episode we explain why auditors are looking for alternatives to traditional audit management software and audit analytics software. About this podcast The podcast for performance auditors and internal auditors that use (or want to use) data. Hosted by Conor McGarrity and Yusuf Moolla. Produced by Risk Insights (riskinsights.com.au).…
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In this episode we discuss a few key matters that auditors need to know relating to the use of AI and auditing AI. 3 key objectives: Bias and ethics. Providing sound decision making support. Maximizing the opportunities. 3 key considerations: Model accuracy. The quality of data. Deploying, controlling, security and change. About this podcast The po…
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