Internal Site Auditing for FDA Computer System Compliance

Instructor: Richard Poser(PhD)
Product ID: 701362
Training Level: Intermediate to Advanced
  • Duration: 90 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: +1-650-565-8542


Read Frequently Asked Questions

This Internal Site auditing webinar will describe a proven process for conducting a comprehensive site audit for inspection of computerized systems and Case studies will be used.

Why should you Attend:
Site inspections of clinical, laboratory and manufacturing facilities always include inspection of the computer systems used in support of these regulated activities. "Show me how you manage your computer systems in compliance with 21CFR Part 11." These words from an FDA or state regulatory inspector can send shivers down your spine. Are your systems ready for an FDA inspection or annual re-inspection at your site?

This presentation will describe a proven process for conducting a comprehensive site audit for inspection of computerized systems. Case studies will be used to illustrate how this process has successfully prepared several manufacturing and laboratory sites from major pharmaceutical companies to answer this question accurately, completely and to the great satisfaction of the inspectors. We will review and illustrate audit plans, system inventory, system audits, CAPA and remediation programs.

Areas Covered in the seminar:

  • 21CFR Part 11 Compliance:
  • Regulatory requirements.
  • Site Inventory.
  • Compliance Assessment.
  • Risk Assessment.
  • Training.
  • Implementing new systems in compliance.

Who will benefit:

This webinar will provide valuable assistance to all regulated companies that need to validate their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
  • End-users responsible for applications that need to be validated
  • QA managers and personnel
  • Information Technology managers and personnel
  • Validation specialists
  • Consultants
  • Quality system auditors
  • Quality Control staff

Instructor Profile:
Rich Poser, 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. Following work in product development, laboratory automation, and validation and quality systems for the Mylan Pharmaceutical Company, Rich joined Dura Pharmaceuticals in San Diego as Analytical Laboratory Director and Director of R&D Quality Assurance. After the acquisition of Dura by √Član, Rich was appointed Director of Quality Laboratory Operations and led their 21CFR Part 11 training and audit team.

Now in private practice as a quality consultant, he also lectures at UCSD Extension in validation, cGMP Regulations and analytical methods validation, and has presented or chaired public seminars on cGMP Requirements, Computer System Validation, Vendor Qualification Auditing, Analytical Methods Validation and Infrastructure Qualification.

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