Seminar - Online
Some time ago FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, now it looks more like an ongoing program with Part 11 related issues being part of most inspection. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003. In the meantime FDA officials reported about key findings and inspectors regularly cited deviations related computer to validation and other Part 11 issues. Because of missing clear guidance from the FDA the industry has lots of questions. Using recent warning letters as examples, this seminar will demonstrate how current Part 11 requirements will be met.
Organization: Compliance Trainings (https://compliancetrainings.com )
For more information, please visit: https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1454
Thursday, May 7, 2015 (13:00 - 14:00)
Mississauga, Ontario 44813, Canada
Contact: Compliance Trainings (suzzane.d@compliancetrainings.com )
Phone: 4169154458
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