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Following a January 2026 inspection, the FDA has issued a formal warning letter to Genzyme Ireland Limited in Waterford, citing data integrity concerns, uncontrolled checklists, and quality unit oversight gaps in the manufacturing of Thymoglobulin and Altuviiio.

The FDA has issued a formal warning letter to Sanofi's Waterford facility, Genzyme Ireland Limited, citing data integrity breaches, discarded quality records, and botched deviation investigations in the production of haemophilia drug Altuviiio and transplant therapy Thymoglobulin.

An educational review of data integrity requirements in pharma QC, covering ALCOA+ principles, audit trails, and data security.

A structured tutorial on handling quality control laboratory OOS results, conducting Phase I/II investigations, and implementing corrective actions.

A definitive 5,000-word guide to public relations for pharmaceutical, biotech, and MedTech professionals. Learn how to build a PR strategy from scratch, which tools to use, how to write for journalists and LinkedIn, and the exact frameworks used by the world's leading life science communications teams.

A complete step-by-step guide for pharmaceutical, biotech and life science professionals on building a credible, visible personal brand on LinkedIn - without ever crossing compliance lines or risking proprietary data exposure. Covers brand strategy, content pillars, storytelling frameworks, and the exact boundaries every pharma professional must respect.

A detailed step-by-step LinkedIn guide for Regulatory Affairs Specialists, Quality Assurance professionals, Pharmacovigilance Officers, CMC Scientists, and all pharmaceutical compliance professionals. Learn exactly how to frame your regulatory expertise on LinkedIn to attract the right roles, visibility, and recognition - without exposing proprietary submissions or confidential regulatory strategy.