ComplianceOnline

IT Infrastructure and Network Qualification- Introduction and Strategies for Compliance and System Uptime

Instructor: Dr. Ludwig Huber
Product ID: 700882
  • 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
Last Recorded Date: May-2008

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

Attend this seminar to learn about proven industry practices for network qualification.

Description

Configuration management and change control as the most important network qualification steps.

Why Should You attend:

Federal laws and regulations mandate to put controls and measures on a company network to ensure security and data integrity. Examples are 21 CFR Part 11, Sarbanes-Oxley Act, and HIPAA. With FDA's renewed focus on computer validation and IT systems, industry is looking for advice on how to comply for networks and infrastructure.

Areas Covered in the seminar:

  • Laws, regulations and guidelines- 21 CFR Part 11, HIPAA, Sarbanes-Oxley.
  • The FDA Industry Guide: Cyber security for Networked Medical Devices.
  • The GAMP/ISPE Good Practices Guide.
  • The IVT proposed NIQ standard.
  • Principles of network infrastructure qualification.
  • Compliance concepts for infrastructure vs. networked systems.
  • Configuration management and change control as the most important network qualification steps.
  • Qualification of PC clients, servers, data centers.
  • What and how much to test with the risk based cost/benefits in mind: network components, servers, PC clients, applications, initial vs. on-going testing.
  • How to ensure highest system uptime with on-line monitoring tools
  • Documentation requirements.
  • Going through a life inspection.
  • Software tools for infrastructure qualification.

For easy implementation, attendees will receive:

  • Copies of all slides
  • Network Qualification Plan
  • SOP: Change Control for Unplanned Changes
  • Checklist: Network Qualification

Note: These complimentary hand-outs will be sent to customers on request. Please email customercare@complianceonline.com for these documents, stating your order number, and they will be emailed to you within 4 working days.

Who will benefit:

  • IT managers and personnel
  • Everybody responsible for FDA compliance of computer systems
  • Managers from purchasing, documentation and operations
  • All users of computer systems used in regulated environments
  • QA managers and personnel
  • GLP/GMP/GCP auditors
  • Consultants
  • Teachers

Instructor Profile:

Ludwig Huber, is one of the leading experts on validation and compliance issues for laboratories. He is the worldwide director for FDA Compliance at Agilent Technologies. A frequent speaker at industry gatherings, Dr. Huber was voted the ‘Presenter of the year’ from among 170 experts by more than a 1000 IVT (http://www.ivthome.com/) conference attendees in 2002. Dr. Huber has conducted over a 100 on-line audio/tele/video seminars and is the author of the books “Validation and Qualification in Analytical Laboratories” and "Validation of Computerized Analytical and Networked Systems", Interpharm Press.

Follow us :
eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada
Computer System Validation - Reduce Costs and Avoid 483s

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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