Warning Letter – OTC Drug manufacturer data integrity issues

The FDA has uncovered circumstances of drug quality data and information being inaccurate, which can mask problems and failures. Patients cannot be assured of the safety and effectiveness of their medication when data has been altered.

One critical way to help ensure product quality is to prevent data integrity lapses from the outset. Over the past two decades, the FDA has publicly outlined its expectations for the accuracy, reliability and truthfulness of all data and information collected by drug manufacturers. In 2018, the agency updated guidance for industry on ensuring data integrity and compliance with CGMP. The FDA’s data integrity guidance aims to help manufacturers have the tools and systems in place to prevent adulterated products from entering the U.S. marketplace. Pharmaceutical quality can only be assured by robust quality control, which includes vigilant oversight of data integrity. This helps ensure the safety, effectiveness and quality of the drug products produced for the American public. When the agency finds manufacturers who are not complying with data integrity requirements, the FDA takes action against those manufacturers’ practices and works to bring them into compliance.

62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

Register (click):  EventZilla Registration Site

Need info?  Email us at training@softwarecpr.com

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