ComplianceOnline

FDA requirements for the Validation of Computer Systems

Instructor: Sonia Gourary
Product ID: 701113
  • Duration: 60 Min

recorded version

$299.00
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: +1-650-963-2556

Email: customercare@complianceonline.com

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.

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