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Speaker Profile
CAROLYN TROIANO

Carolyn Troiano has more than 35 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco, e-cigarette/e-liquid, and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects. 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 and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation. Carolyn has participated in industry conferences and is currently active in several IT and compliance with professional organizations.


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$199.00
Top Ten Best Practices for Establishing a Coherent Validation Compliance Program to Support a Diverse Technology Landscape

 Carolyn Troiano
 June 06 2025
 03 : 00 PM EST    
 90 Minutes
Top Ten Best Practices for Establishing a Coherent Validation Compliance Program to Support a Diverse Technology Landscape

We will explore the best practices and strategic approach for evaluating computer systems used in the conduct of FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety. We will walk through the System Development Life Cycle (SDLC) approach to validation, based on risk assessment, and will also discus..

$199.00
Streamlining Validation of FDA-Regulated Systems: Knowing When You Are Doing Too Much or Not Enough

 Carolyn Troiano
 July 11 2025
 03 : 00 PM EST    
 90 Minutes
Streamlining Validation of FDA-Regulated Systems: Knowing When You Are Doing Too Much or Not Enough

The data integrity principles of “ALCOA+,” Attributable, Legible, Contemporaneous, Original or “True Copy,” Accurate, Complete, Consistent, Enduring, and Available must all be met for FDA-regulated data. These must be tested and confirmed during validation of the FDA-regulated system.We will discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately, in accordance ..

$199.00
Computer System Validation (CSV) Boot Camp

 Carolyn Troiano
 August 08 2025
 03 : 00 PM EST    
 90 Minutes
Computer System Validation (CSV) Boot Camp

We will explore the best practices and strategic approach for evaluating computer systems used in the conduct FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety. We will walk through the System Development Life Cycle (SDLC) approach to validation, based on risk assessment, and will also discuss 2..

Showing 1 to 13 of 13 (1 Pages)
$200.00
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

 Carolyn Troiano
 Recorded Webinar
 90 Minutes
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

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.Areas CoveredCompu..

$200.00
Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA

 Carolyn Troiano
 Recorded Webinar
 90 Minutes
Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA

FDA has substantial authority to oversee regulated companies and their operations. The primary purpose of FDA is to assure safe and effective products that will protect public health. Violations can have seriously adverse effects on products, and ultimately, on patients and consumers.The root of every company’s effort to defend its practices and products is through data and documentation, meaning both struc..

$200.00
Holding Vendors Accountable through Robust Contracts and Service Level Agreements (SLA) for Products and Services Used in FDA-Regulated Operations

 Carolyn Troiano
 Recorded Webinar
 90 Minutes
Holding Vendors Accountable through Robust Contracts and Service Level Agreements (SLA) for Products and Services Used in FDA-Regulated Operations

In this webinar, the attendees will learn about the many best practices that will lead to a better and sounder contract and SLA. It does not require a lot of effort but must be done with diligence.Computer systems that are used in FDA-regulated environments (i.e., the system “touches” an FDA-regulated product or a raw material or packaging component used in conjunction with the product during the manuf..

$200.00
Pharma 4.0: Next Generation Technology Approach to GxP Products, Systems, Data and FDA Compliance

 Carolyn Troiano
 Recorded Webinar
 90 Minutes
Pharma 4.0: Next Generation Technology Approach to GxP Products, Systems, Data and FDA Compliance

Computer system validation has been regulated by FDA for more than 40 years, as it relates to systems used in the manufacturing, testing, and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries. The FDA requirements ensure thorough planning, implementation, integration, testing and management of computer systems used to collect, analyze and/or rep..

$200.00
Functional System Requirements Planning for Computer Systems Regulated by FDA

 Carolyn Troiano
 Recorded Webinar
 60 Minutes
 Download Catalog
Functional System Requirements Planning for Computer Systems Regulated by FDA

This course is intended to provide specific guidelines for coaching attendees on the best practices for developing requirements for computer systems regulated by FDA. There are several key types of requirements that will be covered, including user, functional, performance, system, environmental and other categories.The attendee will learn about the requirements for planning, executing and documenting the re..

$200.00
How Successfully Apply for a Breakthrough Therapy Designation

 Carolyn Troiano
 Recorded Webinar
 60 Minutes
 Download Catalog
How Successfully Apply for a Breakthrough Therapy Designation

The Breakthrough Therapy Designation (BTD) is perhaps one of the most impactful incentives from the FDA as it helps get the product to market much faster than any other expedited approval pathway. Once a drug is successful in getting the BTD, the non-clinical and clinical requirements for market approval are significantly reduced. The applicants can request special meetings with FDA to discuss the developme..

$200.00
Legal, Regulatory and Policy Issues Related to Validation of Computer Systems Regulated by FDA

 Carolyn Troiano
 Recorded Webinar
 60 Minutes
 Download Catalog
Legal, Regulatory and Policy Issues Related to Validation of Computer Systems Regulated by FDA

We will discuss the importance of applying industry best practices when performing the validation process for a computerized system used in an FDA-regulated environment (i.e., the system "touches" product during the manufacturing, testing or distribution process). Such a system must be validated in accordance with FDA guidelines for computerized systems and documented accordingly. There are legal, regulator..

$200.00
Medical Device Software 62304 Compliance

 Carolyn Troiano
 Recorded Webinar
 90 minutes
 Download Catalog
Medical Device Software 62304 Compliance

The webinar will leave you with the information needed to create and maintain good documentation that meets FDA compliance standards. You will learn about what must be done and what must not be done. In addition, you’ll learn about the various computer system validation deliverables and how to document them. This session will provide insight into the IEC 62304 standard as it is applied to medical device sof..

$200.00
New FDA and EMA Labeling Requirements for Regulated Industries

 Carolyn Troiano
 Recorded Webinar
 90 Minutes
 Download Catalog
New FDA and EMA Labeling Requirements for Regulated Industries

This webinar will help you understand in detail the new requirements for labeling from FDA and EMA, including a set of rules for electronic submission of labeling content, and strategies and actions for meeting the new challenges posed.Pharmaceutical companies must manage the process of designing and creating product labels that meet regulatory requirements. This includes product-labeling documents such as ..

$200.00
Writing World Class Compliance Documentation

 Carolyn Troiano
 Recorded Webinar
 60 Minutes
 Download Catalog
Writing World Class Compliance Documentation

Standard operating procedures and work instructions can be an effective tool in the control and standardization of operations, the conduct of training, the meeting of all regulatory requirements, and as user support tools to guide individual performance and to manage the execution of that performance. The key is in knowing how to apply the proper techniques to their creation.Standard Operating Procedures an..

Showing 1 to 13 of 13 (1 Pages)