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Auditing Computer Systems for FDA and International Compliance - Webinar By GlobalCompliancePanel

January 30, 2012

Pharma Development and Business

GlobalCompliancePanel, Online Training 2012-03-13 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. Reference material for easy implementation: SOPs: Validation of Commercial Off-the-Shelf Computer Systems Checklist: Using computers in FDA regulated environments Validation templates and examples Areas Covered in the Session: 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 Conducting the audit: review procedures, walk through the computer system area Most critical questions to ask Auditing for data integrity Auditing in preparation for FDA's ongoing Part 11 initiative Documenting detailed audit findings The audit summary report Effective follow up Presenting evidence of the audit to the FDA Case study: going through a life audit Who Will Benefit: QA managers and personnel QC and Lab managers IT managers and system administrators Validation specialists Regulatory affairs Training departments Documentation department Consultants

Organized by:			GlobalCompliancePanel
Invited Speakers:			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.

Deadline for Abstracts:			2012-03-12

Registration:			Price List: Live : $245.00 Corporate live : $995.00 Recorded : $295.00 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com Phone: 800-447-9407 Fax: 302-288-6884
E-mail:			webinars@globalcompliancepanel.com

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