Live Webinar
on
Auditing Computer Systems for FDA and International Compliance
Date & Time: Tuesday, March 13, 2012
10:00 AM PST | 01:00 PM EST
Duration: 75 Minutes
Instructor: Dr. Ludwig Huber
Location: Online
Price : $245.00
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(for one participant)
Instructor Profile:
Overview: This webinar will give a good understanding of FDA and international expectations for auditing computer systems and provide steps for cost-effective implementation. Auditing of computer systems is important to verify compliance of the systems with regulations and internal standards. When done right, audits can help to improve quality of computer system operation and uptime. In addition audits are also an excellent tool to prepare your organization and staff for external audits, e.g., FDA inspection. However, without a clear strategy audits can become quite complex and ineffective.
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Regulatory requirements: FDA, EU, PIC/S Audit recommendations from the FDA Quality System guidance for cGMPs Effective development and use of audit checklists Developing an SOP for audits of computer systems. Assigning responsibilities
Dr. Ludwig Huber Chief Advisor - Global FDA compliance, Agilent Technologies 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
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Click here to register for this webinar Who Will Benefit: l l l l l l l l
QA managers and personnel QC and Lab managers IT managers and system administrators Validation specialists Regulatory affairs Training departments Documentation department Consultants
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel
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