FDA requirements for the Validation of Computer Systems

Instructor: Sonia Gourary
Product ID: 701113
  • 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
Last Recorded Date: Jan-2009

Training CD / USB Drive

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

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Read Frequently Asked Questions

This Computer System Validation training provides the FDA requirements for the Validation of Computer Systems.

FDA requirements for the Validation of Computer Systems for the Pharmaceutical and biotechnology Industries.

Areas Covered in the seminar:

  • Why validation (quality attributes)
    • FDA requirements (include GMPs,GLPs, GCP, medical devices)
  • What to validate; PLCs, SCADA systems, PC systems etc. What are the differences?
  • SDLC defininition
    • Project management, Change Control, Configuration management etc.
    • 7 stages of the process (cradel to grave)
    • Documentation requirements for each stage of the SDLC
    • Role of IS, QA, senior management etc.
  • Validation deliverables and documentation specifics.
  • Risk Base approach to validation, how?
  • Vendor Audits requirements
  • What to expect from FDA during an inspection
  • Examples of FDA 483’s.
  • Q&A

Who will benefit:

All Pharmaceutical, Device and Biotechnology companies. Personnel from the following functional areas will benefit from this course:

  • Manufacturing/Operation Packaging
  • Quality Assurance
  • Quality Control
  • Quality Audits
  • Validation
  • Regulatory Compliance
  • Process Development
  • Analytical Development
  • QA / Vendor Audit
  • Training

Instructor Profile:
Sonia Gourary, has over 27 years of experience in the pharmaceutical/biotech industries focusing on areas including computer systems, cleaning and process validation, FDA compliance and FDA inspectional readiness programs and business process improvements for remediation of FDA inspectional observations. She has also involved in the development of training programs from executive to entry level employees covering topics ranging from Fundamentals of GMPs for the Manufacturing Environments to in-depth technical focus of computer systems validation for standalone lab equipment to large enterprise systems such as SAP, Documentum, LMS etc. She has worked with Hoffmann-La Roche, Schering-Plough Research Institute, Wyeth Pharmaceuticals and Vaccines, and Amgen. Sonia has also conducted several training seminars for FDA.

Follow us :
Seminars by Ex-FDA Officials
Latin America: Regulatory Compliance Requirements for Life Science Products

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.

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