Compliance training and certification
Compliance training and certification requirements in Healthcare & Life Sciences are tightening, driven by enforcement posture from the U.S. Department of Health and Human Services Office of Inspector General and the U.S. Food and Drug Administration, both of which tie training program adequacy directly to Corporate Integrity Agreement terms and GxP inspection outcomes. The European Medicines Agency has reinforced this through its updated GMP Chapter 2 expectations on personnel qualification documentation. Gaps in training records are no longer treated as administrative deficiencies; they are appearing as audit findings with corrective action timelines.
Watch
- OIG Corporate Integrity Agreement training mandates: scope, frequency, and third-party verification requirements
- FDA GxP inspection findings citing personnel qualification gaps in warning letters
- EMA GMP Chapter 2 personnel competency documentation expectations post-2023 revision
- State-level nursing and allied health CE requirement changes affecting employer compliance obligations
Recent material activity in Healthcare & Life Sciences
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FDA issues Complete Response Letter for novel GLP-1 receptor agonist oral formulation
The FDA issued a CRL for a once-daily oral GLP-1 receptor agonist citing manufacturing consistency concerns at the primary production facility. The agency requested additional CMC data and a pre-approval inspection befor…
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