What inspired us this month

1) Taking the Pressure out of Presenting (live today)

As I prepped to work on Christine Mitchell’s Taking the Pressure out of Presenting masterclass with the RQA team, the waiting list exploded. It was a useful reminder: presenting isn’t just for conference stages. It’s how we win resources, explain risk, and move decisions forward in daily work. Most of us were never actually taught how to do it. We were simply expected to be competent. The demand told its own story.

Why it matters: Clear delivery under pressure is a core QA skill. It protects ideas from being lost in translation and reduces rework born from confusion.

Try this this month

• Rehearse out loud once, even for a 5-minute update.

• Lead with the “one sentence that matters” before any detail.

• Ask a colleague to reflect back what they heard. Edit accordingly.

2) Investing in Growth: CPD that travels well

Our Lead CSV Consultant, John Cheshire, joined an ISPE Commissioning & Qualification event at Kindeva in Loughborough. His takeaway: best practice is transferable. Seeing how manufacturing teams use holistic control strategies sharpened how we think about GLP and GCP oversight.

Why it matters: CPD isn’t a checkbox; it’s leverage. Borrowing patterns from other domains expands our options when the rulebook runs out of examples.

Try this this month

• Pick one practice from another GxP and trial it on a small scale.

• Capture one “cross-pollinated” idea in your next team huddle.

3) Sponsors in GLP: input vs influence, and when rules diverge

Frankie ran a GLP training course with a sponsor team this month and loved the honesty in the room. Two questions kept conversation lively! They’re practical, a bit grey, and exactly where judgement earns its keep.

Delegate question 1 — “If we share historical data to help explain observations, is that sponsor influence?”
Short answer: Share the context; don’t steer the conclusion. The Study Director should review sponsor-supplied information, decide what’s relevant, and explain why. It becomes influence when the SD feels pressure to adjust interpretation or conclusions to fit a preferred narrative.

Delegate question 2 — “Why does a GMP CoA ‘count’ in one region but trigger an exception in another?”
Short answer: GLP principles are harmonised; regulatory expectations aren’t identical. A GMP CoA may be fine for one authority, while another expects the reliance on non-GLP data to be explicitly qualified in the compliance statement. Plan for the delta, not the ideal.

Why it matters
Independence is a people skill as much as a process. Being clear about roles with sponsors protects study integrity, and spotting regional differences early prevents last-minute compliance archaeology.

Try this this month — a 15-minute judgement drill
Build confidence by testing your own read of a grey area, quickly and openly.

1. Pick one live question (e.g., input vs influence, characterisation provenance).

2. Write your one-sentence judgement and two reasons.

3. Check one primary source (e.g. OECD/FDA text) and one peer view; note any gap.

4. Phone a colleague for a 3-minute challenge: “Would you reach the same conclusion? Why/why not?”

5. Capture the result in a judgement log (question, judgement, sources, change if any). Use it next time you hit the same issue.

The point isn’t to be perfect. It’s to practise making defensible calls and to see, over time, that your judgement holds more often than you think.

4) Internal audits: practice with a purpose

Thomas spent this month acting as an “internal auditor” for a team heading towards external scrutiny. Two things stood out.

First, intent changes everything.
When an audit is framed as support, not surveillance, the room relaxes and the truth shows up faster. People stop performing for the audit and start improving the system.

Second, the best audits remove work.
A good internal audit doesn’t create tasks to look busy. It helps you drop low-value activity, strengthen a few controls that matter, and build confidence before customers or regulators arrive.

Why this matters
Done well, internal audits are rehearsal, not exam. They surface risks early, clarify ownership, and make the external visit feel like a formality rather than a cliff edge.

Try this this month — a 20-minute “intent reset”
Before your next internal audit, agree one sentence with the team:

“We’re here to learn what’s strong, see what’s risky, and leave with fewer, smarter actions”.
Open the meeting by saying it, then hold yourselves to it: consolidate actions, name owners, and cut anything that doesn’t change risk.

Action box: small moves for the next 30 days

·Present smarter (2 minutes per update): Write your one sentence that matters and say it out loud once before any high-stakes slot.

·Test your judgement (15 minutes, once a week): Pick one grey question, note your one-sentence call + two reasons, check one primary source, phone a colleague for a 3-minute challenge, and log the result.

·Lower the temperature (15 minutes before your next review/audit): Run a short “meet the auditors/reviewers” huddle and open with purpose: “We’re here to see what’s strong, what’s risky, and leave with fewer, smarter actions.”

·Cross-pollinate (10 minutes): Bring one practice from another GxP/function to your next team huddle and agree a tiny trial.

·Clarify sponsor roles (5 minutes at kick-off): State the boundary once: “Sponsor context welcomed; Study Director owns interpretation.”