Date : Tuesday, July 5, 2011 Time : 10:00 AM PDT | 01:00 PM EDT Duration : 90 Minutes Price : $245.00
Live Webinar Vendor Qualification Auditing for FDA Computer System Compliance
Overview: This Vendor Qualification training will include sample forms and checklists which may be used by the participants, along with some initial training on the appropriate use of forms and checklists. Inspection and auditing of vendors which provide software used to support GXP manufacturing and testing will be explained and illustrated through audit forms, processes and checklists. We will explore how vendor qualification audits may be used in the vendor selection process. Case studies and redacted audit reports will be used throughout the presentation. We will show how audit findings of competitive vendors may be used to select products and negotiate pricing and terms. We will examine the audit process from initial request to conduct an audit through the conduct of on site inspection, closing meetings and audit reports. Areas Covered in the Session: l l l l l
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Audit types Pre-audit materials Conducting site inspections Closing meetings Writing audit observations, recommendations and remediation Use of audits in vendor qualification and selection
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: l
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End-users responsible for using or selecting systems and software products QA Managers and Validation Personnel Information systems managers and personnel Senior Quality, Facilities and R&D Management Regulatory Affairs staff Quality System Auditors
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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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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