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The theme of this Journal is inspection readiness. Ex-MHRA inspector Rachel Carmichael discusses the do’s and don’ts during regulatory inspections, including how and why you should prepare for a live system audit. Lynne Byers looks into FDA/EMA regulatory inspection and enforcement trends, and our experts reveal some of the most common mistakes to avoid during an audit. In our new Journal feature Words of Wisdom, Martin Lush interviews pharma professional Anders Vinther about his 30 years in industry and his predictions for the future. We also include the latest regulatory updates and NSF news.