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We sent our valued clients and colleagues this update last week, but for those of you who are not on our mailing list...
The FDA will begin auditing pharmaceutical companies electronic recordkeeping capabilities to evaluate the industry’s compliance with 21 CFR Part 11.
According the article by Ed Silverman of Pharmalot, “…the FDA is about to begin a series of so-called inspectional findings at many drugmakers… The precise timing and number of facilities to be audited - and these are audits, in effect - has yet to be determined, but they will be conducted by the FDA’s Center for Drug Evaluation and Research, or CDER.”
To view QPharma’s webinar on how to stay Part 11 compliant with your training systems, visit our website here. Simply register on the site to take advantage of the Part 11 recording that, when aired live, attracted over 200 attendees from 7 different countries worldwide. It also contains a high-level overview of iCertify 3.0, QPharma's 21 CFR Part 11 Compliant training system for the life science industry.
For the full article, click here: PharmaLot
QPharma would like to congratulate Alexis Stroud, our Manager of Regulatory Affairs, for being recognized by the HBA as a Rising Star in the life sciences industry!
Alexis began her exceptional career at QPharma since its inception, and quickly became a leader in the Regulatory and Compliance space. Her breadth of knowledge and attention to detail is invaluable; Alexis holds an MBA in Pharmaceutical Management and recently became an ASQ Certified Quality Auditor. She passes this experience on to all levels of the organization and unselfishly volunteers support to every project that come through QPharma’s doors, earning her the respect of both valued clients and admiring colleagues.
If your colleagues were also nominated and recognized for this award, please feel free to share in the comments section below!
Congratulations to all of the Rising Stars and winner of the Women of the Year Award for 2010, GlaxoSmithKline President of North America Pharmaceuticals, Deirdre Connelly, for your prestigious awards!
http://www.qpharmacorp.com/
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