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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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$179.00
Best Practices in Preparation for an FDA Computer System Audit

 Carolyn Troiano
 March 21 2023
 03 : 00 PM EST    
 90 Minutes
Best Practices in Preparation for an FDA Computer System Audit

FDA requires that all computer systems that handle data regulated by the Agency to be validated in accordance with their guidance on computerized systems. In 1997, 21 CFR Part 11 was issued to address electronic records and signatures, as many laboratories and other FDA-regulated organizations began seeking ways to move into a paperless environment. This guidance has been modified over the years to make it ..

$179.00
Best Practices for Auditing of Vendor of Computer Systems Regulated by FDA

 Carolyn Troiano
 March 22 2023
 01 : 00 PM EST    
 90 Minutes
Best Practices for Auditing of Vendor of Computer Systems Regulated by FDA

This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health, organ donation, and tobacco. Functions that are applicable include research and development, clinical sample manufacturing, packaging, labeling and distribution, clinical testing and management, adverse events management, and post-marketing surveillance. You should..

$199.00
Computer Validation: Methodologies and Approaches for Greater Innovation and FDA Compliance

 Carolyn Troiano
 April 19 2023
 01 : 00 PM EST    
 90 Minutes
Computer Validation: Methodologies and Approaches for Greater Innovation and FDA Compliance

Advancements in technology have forced organizations to rethink their 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 ..

$199.00
Computer Software Assurance (CSA) – FDA’s Draft Guidance for Validation of Regulated Computer Systems

 Carolyn Troiano
 May 15 2023
 01 : 00 PM EST    
 90 Minutes
Computer Software Assurance (CSA) – FDA’s Draft Guidance for Validation of Regulated Computer Systems

Advancements in technology have forced organizations to rethink their 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 ..

$199.00
FDA’s Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data

 Carolyn Troiano
 June 13 2023
 01 : 00 PM EST    
 90 Minutes
FDA’s Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data

This webinar will focus on the efforts by FDA to modernize their own technology infrastructure, and what this means to industry. We will cover the Technology Modernization Action Plan (TMAP) that has been launched by FDA for this purpose and discuss specific actions that are planned and in progress.We will also discuss FDA’s more recent push to Software Quality Assurance (SQA) and away from traditional Comp..

$199.00
Trends in FDA Compliance and Enforcement for Regulated Systems

 Carolyn Troiano
 July 17 2023
 01 : 00 PM EST    
 90 Minutes
Trends in FDA Compliance and Enforcement for Regulated Systems

FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC and GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit.As a “GxP” system, following Good Manufacturing, Laboratory and Clinical Practices, the ..

$199.00
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

 Carolyn Troiano
 August 21 2023
 01 : 00 PM EST    
 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..

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

 Carolyn Troiano
 September 11 2023
 01 : 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 venuesCompliant use of Social Media i..

$199.00
Medical Device Cybersecurity and FDA Compliance

 Carolyn Troiano
 October 16 2023
 01 : 00 PM EST    
 90 Minutes
Medical Device Cybersecurity and FDA Compliance

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.Cybersecurity is a serious concern for medical device safety and effectiveness. Without protection, software running on a medical device could cause severe injury or death to a patient.There are many forms of cybersecurity a..

Showing 1 to 15 of 30 (2 Pages)
$200.00
Computer System Validation (CSV) And Software Testing: Applying An Agile Methodology vs. Waterfall For FDA-Regulated Computer Systems And Software

 Carolyn Troiano
 Recorded Webinar
 90 Minutes
Computer System Validation (CSV) And Software Testing: Applying An Agile Methodology vs. Waterfall For FDA-Regulated Computer Systems And Software

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 sy..

$200.00
Trends in FDA Compliance and Enforcement for Regulated Systems

 Carolyn Troiano
 Recorded Webinar
 90 Minutes
Trends in FDA Compliance and Enforcement for Regulated Systems

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. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit. As a “GxP” system, following Good Manufacturing, Laboratory, and Clinical Practices, the ..

$200.00
Data Governance for Computer Systems Regulated by FDA

 Carolyn Troiano
 Recorded Webinar
 90 Minutes
 Download Catalog
Data Governance for Computer Systems Regulated by FDA

Effective and compliant computer system data management is critical to organizations in the pharmaceutical, biologics, vaccines, tobacco, animal health, medical device or other FDA-regulated industry. During the past 30 years, best practices have been developed to ensure computer systems used in these environments can be cost-effectively managed while meeting all aspects of FDA compliance. To take this a st..

$200.00
Disaster Recovery and Business Continuity Planning for Computer Systems Regulated by FDA

 Carolyn Troiano
 Recorded Webinar
 60 Minutes
 Download Catalog
Disaster Recovery and Business Continuity Planning for Computer Systems Regulated by FDA

FDA guidelines are very specific in terms of how computer systems are to be managed, and each company should have a specific strategy and methodology, along with a set of rigorous tactical processes and procedures that prescribe how Disaster Recovery and Business Continuity Planning should be carried out. This is necessary to protect against the onslaught of threats and attacks, both from natural disasters ..

$200.00
FDA Compliance and Clinical Trial Computer System Validation

 Carolyn Troiano
 Recorded Webinar
 90 Minutes
 Download Catalog
FDA Compliance and Clinical Trial Computer System Validation

The FDA governs the computer systems used to collect, analyze, transfer and report data that is in support of human clinical trials required for drug approval. FDA oversight is based on a Predicate Rule, known as “Good Clinical Practices,” or simply, “GCPs.” Computer systems subject to GCP requirements must be thoroughly and appropriately validated in accordance with FDA’s guidance on computer system valida..

$200.00
FDA Compliance and GAMP V Computer System Classification

 Carolyn Troiano
 Recorded Webinar
 90 Minutes
 Download Catalog
FDA Compliance and GAMP V Computer System Classification

We will discuss the importance of classifying computer systems subject to FDA regulations in accordance with GAMP V. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that you do not go beyond what is required for a specific classification of the system so as to be cost-effective...

Showing 1 to 15 of 30 (2 Pages)