My Auditing Journey

8 - Sam Huff

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/

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/
 

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/
 

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/

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/
 

3 - Sue Mann

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 career and openly shares her experiences in this expansive conversation.
 
Some of the topics covered include:
Sue's introduction to the world of auditing and how she learned on the job
Unique audit experiences of her work in the UNIDO Africa GMP development auditing programme, helping under-developed nations with their pharmaceutical quality
Experience as a solo female auditor both in the UK and travelling abroad
 
Want to join Sue 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/
 

2 - Graham Saunders

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 impressive, conducting audits all across the world within all quality areas and Quality Management Systems.
 
In this wide ranging conversation, Graham talks about how he got his start in auditing and how his varied learning experiences shaped and propelled his career in Pharmaceutical Quality.
 
He also shares some illuminating stories from both internal and external audits he has been involved in - shining a light on what is a surprisingly varied skillset required for a pharmaceutical auditor to excel in their role.
 
Want to join Graham 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/

1 - Adam Slater

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 audits and compliance audits mean that Peter and Adam will have plenty to get stuck into.
 
Adam shares his earliest experiences of auditing and reflects on how the industry has improved in both auditing practice and training. We talk about his opinion on how auditors should develop competence through experience and finally Adam recounts some great stories to tell of his auditing experiences – good and bad!
 
Want to join Adam 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/