By John Lafferty, Life Sciences Programme Director at SQT Training Ltd. Read time: 5 minutes The 2023 revision of ICH Q9 (R1) Quality Risk Management guideline brought several clarifications and enhancements to the way the pharmaceutical industry should approach risk management....
Read Moreby John Lafferty, Life Sciences Programme Director at SQT Training Ltd. Read time: 4 minutes. Why This Matters for EU & Irish Medical Device Companies For medical device manufacturers across Ireland and Europe, regulatory audits—whether under MDSAP or ISO 13485—are a cr...
Read MoreBy Gina Ryan Mentoring has a funny reputation in workplaces. Everyone agrees it matters, but many mentoring relationships quietly drift. Meetings become irregular. The mentor feels pressure to have all the answers. The mentee stays polite, but progress slows. In my experience, th...
Read MoreBy Gina Ryan Workplace training is under pressure from two directions at once. On one side, organisations need people to perform consistently and safely. Training has to land, not just be delivered. On the other side, the workforce is more varied than most training materials ...
Read MoreUnderstanding your responsibilities under MDR and why so many organisations are only discovering them now. Author: Anne Marie Newell Over the last few years, the EU Medical Device Regulation (EU MDR 2017/745) has reshaped the responsibilities of companies handling medical device...
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