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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
FDA’s Technology Modernization Action Plan (TMAP) And Impact On Regulated Computer Systems And Data

 Carolyn Troiano
 July 13 2022
 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 the FDA to modernize their own technology infrastructure, and what this means to the industry. We will cover the Technology Modernization Action Plan (TMAP) that has been launched by the 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 tra..

$179.00
Computer System Validation (CSV) And Software Testing: Applying An Agile Methodology vs. Waterfall For FDA-Regulated Computer Systems And Software

 Carolyn Troiano
 August 18 2022
 01 : 00 PM EST    
 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..

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

 Carolyn Troiano
 September 05 2022
 01 : 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
Medical Device Software and FDA Compliance

 Carolyn Troiano
 October 10 2022
 01 : 00 PM EST    
 90 Minutes
Medical Device Software and FDA Compliance

FDA requires that all computer systems used to produce, manage, and report data for “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..

$179.00
C-TPAT Compliance for FDA Regulated Industries

 Carolyn Troiano
 November 08 2022
 01 : 00 PM EST    
 90 Minutes
C-TPAT Compliance for FDA Regulated Industries

The market for counterfeit and contraband or “pirated” products can be divided into two important areas. The primary market provides consumers with counterfeit and contraband products. These consumers believe they have purchased genuine products. However, these products are often below standard and can result in health and safety risks that range from mild to life-threatening. The secondary market provides ..

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

 Carolyn Troiano
 December 08 2022
 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..

Showing 1 to 15 of 28 (2 Pages)
$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
21 CFR Part 11 (Electronic Records/Signatures) Compliance For Computer Systems Regulated By FDA

 Carolyn Troiano
 Recorded Webinar
 90 Minutes
 Download Catalog
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 the 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 CoveredCo..

$200.00
Best Practices in Preparation for an FDA Computer System Validation Audit

 Carolyn Troiano
 Recorded Webinar
 90 Minutes
 Download Catalog
Best Practices in Preparation for an FDA Computer System Validation Audit

Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. Following best practices for developing a validation program that includes planning, execution and maintenance components will ensure that these efforts will meet all regulatory agency requirements and expectations. Preparedness will improve your relationship with the agency and ensure a more ..

$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...

$200.00
FDA Compliance and Mobile Applications

 Carolyn Troiano
 Recorded Webinar
 90 Minutes
 Download Catalog
FDA Compliance and Mobile Applications

We will discuss in detail how computer system validation can be applied to mobile applications subject to FDA regulations. 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 a system is maintained in a validated state throughout its entire life cycle, from conception through r..

$200.00
FDA Deeming Rule for Tobacco Related Products and Recent Actions: eCigarettes, eLiquids, Cigars

 Carolyn Troiano
 Recorded Webinar
 90 Minutes
 Download Catalog
FDA Deeming Rule for Tobacco Related Products and Recent Actions: eCigarettes, eLiquids, Cigars

This webinar is intended for those working in the FDA-regulated tobacco and related industries, including e-liquids (vapor), e-cigarettes, cigars, and smokeless tobacco products. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.You should attend this webinar..

Showing 1 to 15 of 28 (2 Pages)