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...
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 himself in and how these experiences have made him a better auditor.
We also hear about how the Lead Auditor course has shaped his career and what he has learned beyond the classroom, including:
Why being mentally sharp is crucial when conducting an audit
The importance of understanding and recalling standards
How to strike the right tone in an audit and why it matters
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Want to follow in Sam's footsteps and become a pharmaceutical auditor? From nurturing early-career talent, to fostering continuous professional development (CPD), RSSL provides you with a comprehensive auditing career path giving you a powerful platform to propel your career further: https://www.rssl.com/training-consultancy/auditing-career-path-training-programme/
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7 - Marc Helouin
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, Marc has been involved with domains ranging from quality assurance, corporate audit, supply chain assurance, commercial compliance and more.
Coupled with his degree in chemistry, Marc also holds a law degree and is a member of the bar for the state and federal courts of Ohio, as well as being a member of the bar of the Supreme Court of the United States. As if this isn't enough, Marc is also a graduate of the US Navy's Nuclear Power School, subsequently rising to the rank of lieutenant commander.
With a CV as long as your arm Peter and Marc found plenty of fertile ground to cover on Marc's experience of auditing, not only on both sides of the table but both sides of the Atlantic. Marc shares how his background in law helped his auditing, how crucial frameworks can be when investigating GMP environments, how being proactive auditee can work to your benefit and just how difficult it can be navigating an audit where English isn't necessarily the first language.
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Want to follow in Marc's footsteps and become a pharmaceutical auditor? From nurturing early-career talent, to fostering continuous professional development (CPD), RSSL provides you with a comprehensive auditing career path giving you a powerful platform to propel your career further: https://www.rssl.com/training-consultancy/auditing-career-path-training-programme/
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6 - Peter Rooney
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 two Peters drill down into what auditors want to see in terms of quality control when they visit laboratories, whether that's a multi-site global pharmaceutical brand or a two person operation working out of the side building of a house. They discuss to how to deal with equipment obsolescence, how to gauge "quality culture" and just how much more difficult complex data systems have made the job.
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Want to follow in Peter's footsteps and become a pharmaceutical auditor? From nurturing early-career talent, to fostering continuous professional development (CPD), RSSL provides you with a comprehensive auditing career path giving you a powerful platform to propel your career further: https://www.rssl.com/training-consultancy/auditing-career-path-training-programme/
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5 - Clive Brading
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 Pharmaceutical Audit Programmes. From planning how to use limited auditing resources effectively through to how to deal with the vast amount of data at your fingertips, Clive and Peter guide us through some of the more esoteric problems that may arise during an auditors career.
Find out how to manage difficult situations and why its best to maintain the human touch in this fascinating conversation.
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Want to join Tony in becoming a pharmaceutical auditor? From nurturing early-career talent, to fostering continuous professional development (CPD), RSSL provides you with a comprehensive auditing career path giving you a powerful platform to propel your career further: https://www.rssl.com/training-consultancy/auditing-career-path-training-programme/
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4 - Tony Orme
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 development of almost all important UK GDP policies and so his understanding of the practical application of GDP, Human Medicines Regulations and the medicines supply chain runs deep.
In our latest episode Tony shares his experiences at the head of the MHRA inspection team, the ideal way to approach a risk based audit programme and invaluable techniques and tips to help you get the best out of an audit.
Want to join Tony in becoming a pharmaceutical auditor? From nurturing early-career talent, to fostering continuous professional development (CPD), RSSL provides you with a comprehensive auditing career path giving you a powerful platform to propel your career further: https://www.rssl.com/training-consultancy/auditing-career-path-training-programme/
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 share of audits on both sides. In our first series of Conversations on the Pharmaceutical Industry, Peter talks to some of the UK’s most seasoned pharmaceutical auditing professionals, exploring their career trajectories, what drew them to auditing, and the surprises they’ve encountered along the way. From their start in the industry to their most challenging audits, we’ll unravel the insights that shape each auditors unique perspective.
Whether you’ve been auditing for years or you’re just starting out, this is sure to be an insightful look at what it takes to be an auditor. Subscribe now and join Peter to find out how you can make it in this important and rewarding career.
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