ComplianceOnline

Computer System Auditing 21CFR Part 11 Compliance

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

recorded version

$249.00
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

$500.00
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: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

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

Description

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.

Follow us :
ComplianceOnline Medical Device Summit 2017

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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