Computer System Auditing 21CFR Part 11 Compliance

Instructor: Richard Poser(PhD)
Product ID: 700884
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556


Read Frequently Asked Questions

The webinar will address each audit item and train the participants how to determine the compliance status.


We will use common examples of non-compliance observations from actual audits and suggest remediation plans that are compliant, efficient and economical.

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:

  • 21CFR Part 11 Requirements.
  • Regulatory Inspections of Computer Systems.
  • Risk-Based Inspection and Validation.
  • System Inventory Assessment - Preliminary Risk Assessment.
  • Compliance Assessment - Compliance Risk Analysis, Gap Analysis and Corrective Actions.
  • Remediation Plans and Schedules.

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.

  • 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

Instructor Profile:

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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