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Carolyn Troiano

IT Program Manager and FDA Compliance Consultant,

Carolyn (McKillop) Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.

During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.



  •  Monday, August 27, 2018
  • 10:00 AM PDT | 01:00 PM EDT,
  • 90 Minutes
  • ¤150.00
Computer System Validation (CSV) for FDA-Regulated Computers

FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules.

  •  Tuesday, September 11, 2018
  • 10:00 AM PDT | 01:00 PM EDT,
  • 90 Minutes
  • ¤150.00
Medical Device Cybersecurity -Improving Compliance and your Company's Bottom Line

This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats.

  •  Monday, September 24, 2018
  • 09:00 AM PDT | 12:00 PM EDT,
  • 3 Hours
  • ¤290.00
3-Hour Virtual Seminar Computer System Validation (CSV) for FDA-Regulated Computers

FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated

  •  Friday, October 12, 2018
  • 09:00 AM PDT | 12:00 PM EDT,
  • 3 Hours
  • ¤290.00
3-Hour Virtual Seminar FDA's New Draft Guidance on Software and Device Changes and the 510(k)

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA.





  • Recorded
  • View Anytime
  • 90 Minutes
  • ¤190.00
Computer System Validation (CSV) for FDA-Regulated Computers

FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules.

  • Recorded
  • View Anytime
  • 90 Minutes
  • ¤190.00
Medical Device Cybersecurity -Improving Compliance and your Company's Bottom Line

This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats.

  • Recorded
  • View Anytime
  • 3 Hours
  • ¤340.00
3-Hour Virtual Seminar Computer System Validation (CSV) for FDA-Regulated Computers

FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated

  • Recorded
  • View Anytime
  • 3 Hours
  • ¤340.00
3-Hour Virtual Seminar FDA's New Draft Guidance on Software and Device Changes and the 510(k)

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA.