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At the International GMP Conference held virtually in early March 2021 co-sponsored by the University of
Next week, a virtual conference will feature a presentation by Redica Systems Senior GMP Quality Expert
Gene therapies are an emerging and promising field of medicine that offers cures for rare and debilitating
FDA recently posted a 38-page form 483 issued to Novel Laboratories, Inc d.b.a.
December is generally a slow time when it comes to posting of FDA Warning Letters. Nevertheless, on Dec.
The week of the U.S. Thanksgiving holiday was yet again another week that was light on Warning Letter
[Editor's Note: This is Part II of an analysis of the FY2019 UK MHRA GMP deficiencies by Redica Systems
[Editor's Note: Below is Part I of an analysis of the U.K. MHRA GMP deficiencies for 2019. Part II will
A comprehensive GMP intelligence program includes monitoring health authority enforcement actions.