We are required to manage the quality and assure the validation state of computer systems used in support of regulated pharmaceutical processes (cGMP, GLP, GCP, QSR). This presentation will go over the "how-to" in a way that is simple and intuitive. We will include templates for auditing computer systems used in support of regulated GXP processes.
Areas Covered in the seminar:
Who will benefit:
This webinar will provide valuable assistance to all regulated companies that need to manage the quality and validation state of their computer systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. Contract facilities providing clinical, laboratory and data systems will also benefit.
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. Dr. Poser was Director of Analytical Sciences and later Director of Information Systems at the Fisons Pharmaceuticals site in Rochester, NY.
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