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Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11
Course "Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11" has been pre-approved by RAPS as eligible for up to 1.25 credits towards a participant's
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RAC recertification upon full completion.
Date & Time:
Instructor Profile:
Thursday, April 26, 2012
10:00 AM PDT | 01:00 PM EDT
Duration: 75 Minutes
Instructor: Dr. Ludwig Huber
Location: Online
Price : $245.00
Dr. Ludwig Huber Chief Advisor - Global FDA compliance, Agilent Technologies
(for one participant)
Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor of Labcompliance, the global on-line resource for validation and compliance issues for laboratories. He is the author of the books "Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare. ...more
Overview: In July 2010, the FDA announced to conduct a series of inspections related to 21 CFR Part 11. In meantime the program is still on-going. FDA made it very clear that Part 11 is in effect and will be enforced according to original Part 11 and the guidance from 2003. While this guidance leaves a lot of room for interpretation and uncertainty an excellent way to find out FDA's expectations is learn from recent Part 11 related warning letters. Just from 2007-2012, there have already been more than 50 warning letters and 483's with deviations related to computer system validation and Part 11 compliance, some with disastrous consequences for inspected companies.
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FDA inspections: Preparation, conducts, follow up The meaning of warning letters and 483 inspectional observations Learning from an FDA presentation: "Data Integrity and Fraud
Examples of recent 483' and warning letters related to computer system validation 'Most obvious reasons for deviations Responding to 483's to avoid warning letters
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Case study: going through a life audit
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Your Necessity is our Priority
- Another Looming Crisis?" FDA's new focus during inspections of computer systems and e-records Examples of recent Part11 483's and warning Letters
Writing corrective and preventive action plans to avoid 483 Strategies and tools for compliant Part 11 implementation The future of Part 11and computer system validation
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Click here to register for this webinar Who Will Benefit: l l l l l l l l l l
Pharmaceutical, API and Medical Device Industry Part 11 groups in Bio(pharmaceutical) and device industry Software developers IT Managers and System Administrators QA Managers and Personnel Analysts and Lab Managers Validation Professionals Training Departments Documentation Department Consultants
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