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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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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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