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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, October 22, 2018
  • 10:00 AM PDT | 01:00 PM EDT,
  • 90 Minutes
  • ¤150.00
The 21st Century Cures Act - Expediting New Products and New Product Indications

The 21st Century Cures Act (Cures Act), signed into law on December 13, 2016, is designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently.

  •  Friday, November 2, 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, November 9, 2018
  • 10:00 AM PST | 01:00 PM EST,
  • 90 Minutes
  • ¤150.00
Disaster Recovery and Business Continuity Planning for Computer Systems Regulated by FDA

Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacture, testing, distribution and management of a product in the pharmaceutical, biotechnology, medical device, animal health, tobacco and other regulated industries.

  •  Tuesday, November 27, 2018
  • 09:00 AM PST | 12:00 PM EST,
  • 3 Hours
  • ¤290.00
3-Hour Virtual Seminar - 21 CFR Part 11 - Guidance for Electronic Records and Electronic Signatures used in FDA-Regulated Computer Systems

The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.





  • 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
  • 90 Minutes
  • ¤190.00
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
The 21st Century Cures Act - Expediting New Products and New Product Indications

The 21st Century Cures Act (Cures Act), signed into law on December 13, 2016, is designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently.

  • Recorded
  • View Anytime
  • 90 Minutes
  • ¤190.00
Disaster Recovery and Business Continuity Planning for Computer Systems Regulated by FDA

Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacture, testing, distribution and management of a product in the pharmaceutical, biotechnology, medical device, animal health, tobacco and other regulated industries.