Internal 21CFR Part 11 Compliance Auditing of Computer Systems

Some of these sessions are too basic - this one had a good mix of basic and details. The tips are helpful. One comment: a little more discussion regarding the use of Detection in FMEAs would be useful since many do not advocate its use. Thanks,

I especially liked that the Q&A session after the webinar was long enough to not only address my own questions but also to learn from the questions from the other participants in the webinar.

Very thorough understanding of the history/progression of the guidances, and very helpful evaluation of current and potential directions. Excellent presentation skills, very engaging.

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Internal 21CFR Part 11 Compliance Auditing of Computer Systems

Internal 21CFR Part 11 Compliance Auditing of Computer Systems

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Instructor : Richard Poser

Product Id : 600142

Overview: This presentation will describe a proven process for preparing a site for inspection of systems.

Case studies will be used to illustrate how this process has successfully prepared several pharmaceutical companies to answer this question accurately, completely and to the great satisfaction of the inspectors. We will review and illustrate audit plans, system inventory, system audits, CAPA and remediation programs.

Why should you attend:
"Show me how you manage your computer systems in compliance with 21CFR Part 11." These words from an FDA or state regulatory inspector can send shivers down your spine. Are you ready for an internal QA or FDA inspection at your site?

Areas Covered in the Session:

21CFR Part 11 Compliance
Review of the regulations
Regulatory requirements
Site Inventory
Compliance Assessment
Risk Assessment

Who Will Benefit: This webinar will provide valuable assistance to all regulated companies that need to validate their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields and associated vendors such as contract research, manufacturing, testing and systems. The employees who will benefit include:

End-users responsible for applications that need to be validated
QA managers and personnel
Information Technology managers and personnel
Validation specialists
Consultants
Quality system auditors
Will provide forms and templates for the processes

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. Following acquisition of Dura by Elan, Rich was appointed Director of Quality Laboratory Operations and led their 21CFR Part 11 training and audit team. Now in private practice as a quality consultant, he also lectures at UCSD Extension in validation and has presented or chaired public seminars on cGMP Requirements, Computer System Validation, Vendor Qualification Auditing, Analytical Methods Validation and Infrastructure Qualification.

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