My Auditing Journey

This week, Peter Deegan sits down with newly qualified QP Mike Hadebe, who shares his inspiring path from NHS pharmacist to QA specialist and ultimately to QP success. In this episode, Mike opens up about: - How he built a support network of QPs to learn from diverse experiences - The value his clinical background brought to the QP application process - Why staying sharp on regulatory changes is essential ahead of your Viva Mike's journey is a must-listen for anyone on the QP path or for QP mentors. - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - If you'd like to follow in Mike's footsteps you can start with us by checking out our suite of QP courses here: https://www.rssl.com/life-science-training-consultancy/qualified-person-training-programme/

After learning about the responsibilities of a QP and attending an introductory training module from RSSL, Rebeca Bruzzichessi decided that the role of a Qualified Person was a privilege she wanted to shoulder. In our latest episode of My QP Journey, host Peter Deegan dives into Rebeca's journey through her training and all the way to recently passing her viva. From setting up support networks to being proactive in gaining the necessary experience for her application, Rebeca tells Peter all about what she learnt throughout the process, including: How she balanced her management role with getting hands on experience How she used one particular core module to ensure her application felt interconnected How she would do things differently if she had to do it again. So whether you're thinking about becoming a QP or already on the way, this conversation offers insight into the process and valuable advice from a newly qualified QP.

In the latest episode of My QP Journey, Gurpreet Birch shares with host Peter Deegan how after exploring various roles that left her feeling unsatisfied, she found her true calling as a Qualified Person (QP). After self funding her initial training with RSSL, she focused on making strategic career moves that offered the widest diversity of experience - experience vital for constructing a strong QP application. In her discussion with Peter, Gurpreet talks about the challenges she faced on her way to a successful Viva, including: How she approached the order of the requirements in her own unconventional way Ensuring she found the sponsor that fitted with her way of working How she managed the impact of her studies on her family. Its a fun and insightful discussion whether you are thinking about becoming a QP or already on the way to being one.

We're back with a brand new series in our Conversations on the Pharmaceutical Industry podcast, this time diving deep into the experiences of Qualified Persons (QPs)!   In the first episode, Peter is joined by Blair McKay, a newly qualified RSSL QP course alumni. Blair's journey to becoming a QP is particularly unique, having started just as the global pandemic began.   In this episode, Blair shares how he adapted to socially distanced learning, his structured approach to completing the QP application, top tips for successfully passing the Viva and the importance of staying positive during overwhelming moments.   Curious about becoming a QP? Check out our QP career path and tap into the expertise and guidance we offer to help you succeed in this exciting field! https://www.rssl.com/life-science-training-consultancy/qualified-person-training-programme/

As pharmaceutical supply chains diversify auditors are regularly faced with new and unconventional challenges. How would you approach auditing a rural snake farm providing key materials that will potentially save patient lives? With 25 years of pharmaceutical experience across all stages of development and manufacturing, Tracy Sienko has faced every kind of challenge giving her the opportunity to think deeply about her role and how well she can perform it. On our latest episode she and Peter discuss the important foundation formal auditing training provides, how consistency across audits boosts auditee confidence and how to handle suppliers who may not be as cooperative as others.   -------------------------------------------------------------------------------------------------------------------   If you enjoyed this episode and wanted to follow in Tracy's footsteps please check out our Auditing Career Path Programme. 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/

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   -------------------------------------------------------------------------------------------------------------------   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/

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.   -------------------------------------------------------------------------------------------------------------------   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/  

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.   -------------------------------------------------------------------------------------------------------------------   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/  

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.   ---------------------------------------------------------------------------------------------------   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 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/  

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/  

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/

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/