Date : Tuesday, July 19, 2011 Time : 10:00 AM PDT | 01:00 PM EDT Duration : 90 Minutes Price : $245.00
Live Webinar Auditing Systems for 21CFR Part 11 Compliance
Overview: Life sciences companies should regularly audit and assess computer systems for 21CFR Part 11 compliance, both their internal systems used in support of regulated GxP activities as well as systems used by their contract vendors for manufacturing, laboratory testing, drug safety and clinical studies. This is done routinely as self-assessment and inventory of existing systems, during the implementation of new systems, as during vendor qualification and periodic audits. Areas Covered in the Session: l l l l l l
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21CFR Part 11 Requirements Regulatory Inspections of Computer Systems Required Policies and Procedures Training Performing a Comprehensive Inventory: Team Effort System Inventory Assessment - Preliminary Risk Assessment Compliance Assessment - Compliance Risk Analysis, Gap Analysis and Corrective Actions Remediation Plans and Schedules Presenting to the Inspector Case Studies: Federal and State Regulatory Inspections
Click here to register for this webinar Who Will Benefit:This webinar will provide valuable assistance to all regulated companies that need to prepare for inspection of the facilities, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. Contract facilities providing clinical, laboratory and data systems will also benefit. The employees who will benefit include:
Register Now Instructor Profile: Richard Poser President, First Quality Inc
Richard Poser,PhD is President of First Quality Inc., a quality consulting firm focused on Quality Systems, Training and Validation. Their clients include biotechnology, pharmaceutical and medical device manufacturers, as well as the vendors such as contract laboratories, instrument manufacturers, contract manufacturing sites and software developers that support these highly regulated industries. Following an academic career in drug metabolism and chemotherapy, Dr. Poser was Director of Analytical Sciences and later Director of Information Systems at the Fisons Pharmaceuticals site in Rochester, NY. He joined Dura Pharmaceuticals in San Diego as Analytical Laboratory Director and Director of R&D Quality Assurance. ...more
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ISO 13485 Quality Manual
Intro to ISO 13485 Presentation Materials ISO 13485 Internal Auditor Checklist
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End-users responsible for applications and systems QA Managers and Personnel Information Technology Managers and Personnel Senior Quality, Regulatory and Operations Management Regulatory Affairs staff Quality System Auditors
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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
About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals. GlobalCompliancePanel www.globalcompliancepanel.com 1000 N West Street Suite, 1200 Wilmington DE 19801
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