Common-Sense Auditing
A Conference Highlight with Dominic Parry and Dave Rushton
Among the most memorable and entertaining sessions at the 2025 UK GDP Association Annual Conference was the lively joint presentation on Common-Sense Auditing, delivered by two highly respected industry experts, Dominic Parry of Inspired Pharma and Dave Rushton of Paradigm Shift Consulting and Chairman of the UK GDP Association.
Both speakers brought decades of specialised experience in GMP, GDP, auditing, and quality leadership. Their combined session blended practical guidance with humour, perspective, and impressive ability to make the often-daunting world of auditing feel accessible, logical and even enjoyable.
About the Speakers
Dave Rushton – Paradigm Shift Consulting
Dave brings extensive experience in GDP, auditing, QMS development, and compliance remediation. Through his work with Paradigm Shift, he advises organisations on how to build sustainable, user-friendly quality systems that both meet regulatory expectations and support efficient business operations. His style is direct, engaging, and grounded in helping companies achieve compliance without unnecessary complication or excessive costs.
Dominic Parry – Inspired Pharma
Dominic is a well-known figure in pharmaceutical quality training and consulting. As a director and senior trainer at Inspired Pharma, he supports organisations across the UK and globally with GMP, GDP, and auditing courses. His background spans operational leadership, quality management, and global regulatory compliance, experience that translates into practical, real-world teaching.
The combination of Dominic’s formal training expertise and Dave’s consultancy pragmatism created a dynamic, insightful presentation enjoyed by all delegates.
About the companies
Paradigm Shift Consulting
Paradigm Shift Consulting focuses on helping pharmaceutical and healthcare businesses improve their quality systems, operational processes, and audit readiness. The company provides tailored GDP and GMP consultancy, internal and supplier audits, and QMS redesign and remediation. Their philosophy centres on simplification, sustainability, and building systems that work for the people who use them, not just for the regulators.
Inspired Pharma
Inspired Pharma provides specialist training courses, consultancy and auditing services across the global pharmaceutical and healthcare sectors. Their courses, covering GMP, GDP, auditing skills, pharmaceutical quality systems, and more, are widely recognised for clarity, relevance, and strong regulatory alignment. The organisation has become a trusted partner for companies seeking practical guidance on compliance, QMS capability, and regulatory inspections.
Common-Sense Auditing: Key Themes from the Session
Dominic and Dave opened their session with a clear message:
“Auditing is not about finding faults. It’s about understanding compliance and supporting improvement.”
The audience was encouraged to rethink the word audit, not as a hunt for deficiencies, but as a constructive, risk-based, evidence-driven process that strengthens quality systems and promotes operational excellence.
What Makes a Good Auditor?
According to Dominic and Dave, auditors should model have the following attributes:
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- Integrity
- Professionalism
- Confidentiality
- Independence
- Evidence-based judgement
- Risk-based thinking
- Standards focused
- Fair and balanced reporting
Their message was simple: Great auditors don’t catch people out; they work with them to help ensure the organisation is operating safely and compliantly.
Why we Audit
There are many reasons to carry out audits, including:
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- Assessing compliance
- Evaluating a supplier
- Investigating deviations
- Reviewing changes
- Identifying risks
- Driving improvements
Dominic emphasised one point repeatedly: “Audits should never be conducted just to find faults.”
A fault-finding approach damages trust, restricts openness, and ultimately results in poorer audit outcomes.
Types of Audits
The session then broke down the different categories of audits:
- First-party audits – internal audits of processes and procedures.
- Second-party audits – supplier and outsourced activity audits.
- Third-party audits – regulatory inspections (MHRA, ISO), or consultant-led pre-inspection audits.
The presenters addressed the increasing trend of organisation calling in consultants only when they receive an inspection notice. Their advice was clear:
Periodic consultant audits or gap assessments are far more valuable and far less stressful than last-minute preparation.
This is particularly important for smaller organisations or “one-person QMS teams”, where it is easy to become too familiar with systems and become ‘blind’ to any systemic failings or gaps. Fresh eyes bring a fresh perspective.
Expectations from EU Guidelines and MHRA Green Guide Chapter 8 (Self-Inspections)
This session at the conference references the established guidance for self-inspections, including:
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- A defined audit schedule.
- Clear timelines for completing audits.
- Assurance of auditor competence.
- Full reporting and documented management review.
- Use of CAPA or change control for deficiencies against the standards.
Dominic reinforced that audits are only beneficial if the findings lead to meaningful and timely improvement.
The Aide Memoire: A Useful, Not Limiting, Tool
Dominic and Dave encouraged auditors to use an aide memoire, a checklist or summary of key GDP, GMP, ISO points relevant to the audit. However, they warned against using it as a ridged boundary.
“If you see something concerning that isn’t on the checklist, don’t ignore it. Explore it then resume audit based on the aide memoire.”
This flexible mindset is essential for thorough, responsive, risk-based auditing.
A Light-Hearted and Engaging Session
Delegates praised the session for being one of the most enjoyable of the entire conference.
Dominic and Dave’s rapport, humour, and honest storytelling made the topic come alive. Their practical examples from decades of audits, good and bad, helped contextualise the principles and reinforced the message that auditing should be logical, fair and rooted in quality culture.
Their down-to-earth delivery was a powerful reminder that compliance does not need to be complicated or intimidating. With the right attitude, tools, and mindset, auditing can be a positive, insightful, and even enjoyable part of maintaining a robust pharmaceutical quality system.
We are hoping for another fun-filled and informative session from the dynamic duo at our 2026 Annual Conference.
Registering for the 2026 Conference
The UK GDP Association C.I.C (Community Interest Company) is delighted to announce that our third Annual Conference will be held on Tuesday 16th June 2026 and Wednesday 17th June 2026, in Northampton.
There are discounted tickets available for UK GDP Association members, members can save £100 when attending both conference days. However, our commitment to low-cost, high-value educational content means that conference tickets will still be the best value whether you chose to join as members or not.
Membership is only £29 +VAT per individual, per year and offers reduced costs on consulting, training and conference tickets. If you buy tickets for both conference days, there is an even greater discount. Costs for non-members is just £224.50 per day, a fraction of the cost of other industry events!
In addition, on the evening of Tuesday 16th June, we will be hosting an evening event of dinner, networking, and even some of Dave’s infamous karaoke, for just £49 +VAT per person. This is a fundraising dinner in aid of the MVA Society.
Please see here for more information on the conference and to book your conference and evening dinner tickets.
We are very much looking forward to seeing you all at the conference!
2025 Conferences
