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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
Business Process Mapping: Streamlining Management of Data/Records for a Clinical Trial from a Variety of Stakeholders And Systems

 Carolyn Troiano
 March 19 2025
 03 : 00 PM EST    
 90 Minutes
Business Process Mapping: Streamlining Management of Data/Records for a Clinical Trial from a Variety of Stakeholders And Systems

The plethora of data, both structured database records and unstructured data, such as documents, PDFs, Excel spreadsheets, and other key artifacts, makes the assembly of a clinical TMF/eTMF a daunting effort. There are many stakeholders sending in key data about the trial to the sponsor. The many artifacts come from a variety of systems based on differing technologies and platforms and using differing commu..

$199.00
Holding Vendors Accountable through Robust Contracts and Service Level Agreements (SLA) for Products and Services Used in FDA-Regulated Operations

 Carolyn Troiano
 April 07 2025
 03 : 00 PM EST    
 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..

$199.00
Navigating the Complexities of Newer Technologies When Validating FDA-Regulated Systems

 Carolyn Troiano
 May 09 2025
 03 : 00 PM EST    
 90 Minutes
Navigating the Complexities of Newer Technologies When Validating FDA-Regulated Systems

Advancements in technology have forced companies to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and have higher expectations than ever before. Work practices and tools must change to meet these challenges.The approach to developing software, performing validation and maintaining a system i..

$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..

$199.00
FDA Compliance for Regulated Systems using COTS, Cloud, and SaaS Solutions

 Carolyn Troiano
 September 05 2025
 03 : 00 PM EST    
 90 Minutes
FDA Compliance for Regulated Systems using COTS, Cloud, and SaaS Solutions

Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.The approach to developing software, performing validation and maintaining a syst..

$199.00
Computer System Validation (CSV) vs. Computer System Assurance (CSA): Aligning Agile to the GAMP®5 “V” Model And System Development Life Cycle (SDLC)

 Carolyn Troiano
 October 03 2025
 03 : 00 PM EST    
 90 Minutes
Computer System Validation (CSV) vs. Computer System Assurance (CSA): Aligning Agile to the GAMP®5 “V” Model And System Development Life Cycle (SDLC)

Most of the concerns of industry can be managed through contracts and Service Level Agreements (SLAs) that benefit both provider and client. It all depends on how much a company is willing to trust a vendor and how much money they’re willing and able to pay for the service. A key to success is having a tight contract where the client can include the leverage with which they want to hold the cloud service pr..

$199.00
Clinical Trial Systems: Trial Master File (TMF) and eTMF, And FDA’s Recent Draft Guidance for Electronic Records/Signatures Used in Clinical Trials

 Carolyn Troiano
 November 07 2025
 03 : 00 PM EST    
 90 Minutes
Clinical Trial Systems: Trial Master File (TMF) and eTMF, And FDA’s Recent Draft Guidance for Electronic Records/Signatures Used in Clinical Trials

Documents contained in the TMF must be available for inspection by the appropriate regulatory authorities at any time during and after the conduct of a clinical trial, and must be submitted to support the request for product approval. This is true for pharmaceuticals, biologics and medical devices. More recently, tobacco and tobacco related products have come under regulation by FDA, and will also be discus..

$199.00
Data Integrity and Privacy: 21 CFR Part 11, Annex 11, and General Data Protection Regulation (GDPR)

 Carolyn Troiano
 December 05 2025
 03 : 00 PM EST    
 90 Minutes
Data Integrity and Privacy: 21 CFR Part 11, Annex 11, and General Data Protection Regulation (GDPR)

Documents contained in the TMF must be available for inspection by the appropriate regulatory authorities at any time during and after the conduct of a clinical trial, and must be submitted to support the request for product approval.  This is true for pharmaceuticals, biologics and medical devices.  More recently, tobacco and tobacco related products have come under regulation by FDA, and will al..

$199.00
Data Privacy: California Privacy Rights Act (CPRA), Health Information Portability And Accountability Act (HIPAA), and General Data Protection Regulation (GDPR)

 Carolyn Troiano
 January 20 2026
 03 : 00 PM EST    
 90 Minutes
Data Privacy: California Privacy Rights Act (CPRA), Health Information Portability And Accountability Act (HIPAA), and General Data Protection Regulation (GDPR)

The California Consumer Privacy Act (CCPA) was enacted into law on June 28, 2018 and became effective on January 1, 2020. CCPA provided a variety of consumer privacy rights and the obligations of business related to their storage and sale of personal information.Voters in California voted to approve Proposition 24, a ballot measure, on November 3, 2020, which created the California Privacy Rights Act (CPRA)..

$199.00
FDA Guidance on the Use of Social Media: Know Your Responsibilities and Potential Liabilities

 Carolyn Troiano
 March 12 2026
 03 : 00 PM EST    
 90 Minutes
FDA Guidance on the Use of Social Media: Know Your Responsibilities and Potential Liabilities

This webinar will help you understand in detail the application of FDA’s guidance on the use of social media in presenting and promoting information about drug products and medical devices subject to FDA regulation.  This is critical in order to develop the appropriate strategy, policies and procedures to ensure compliance.Areas CoveredPros and cons of using social media venues Compliant use of Social ..

Showing 1 to 15 of 21 (2 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
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..

Showing 1 to 15 of 21 (2 Pages)