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

 Carolyn Troiano
 December 11 2024
 03 : 00 PM EST    
 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..

$249.00
Computer System Validation (CSV) 3-Hours Boot Camp

 Carolyn Troiano
 January 21 2025
 11 : 30 AM EST    
 180 Minutes
Computer System Validation (CSV) 3-Hours Boot Camp

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 ..

Showing 1 to 15 of 26 (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
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
COTS, Cloud, and SaaS Systems and FDA Validation Compliance

 Carolyn Troiano
 Recorded Webinar
 90 Minutes
COTS, Cloud, and SaaS Systems and FDA Validation Compliance

“How can we perform an Installation Qualification (IQ) when the server is completely under the control of a vendor?”“How do we know the vendor will be able to manage security, backups, disaster recovery, and other aspects required to ensure data is collected and maintained with integrity?”“What about change control?”“How will we handle compliance with 21 CFR Part 11, FDA’s guidance for electronic records an..

$200.00
FDA Guidance on the Use of Social Media: Know Your Responsibilities and Potential Liabilities

 Carolyn Troiano
 Recorded Webinar
 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..

$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
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..

$200.00
FDA's Recent Clarification on Guidance for Managing Data Integrity for Regulated Systems

 Carolyn Troiano
 Recorded Webinar
 90 Minutes
 Download Catalog
FDA's Recent Clarification on Guidance for Managing Data Integrity for Regulated Systems

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
Functional System Requirements for Computer Systems Regulated by FDA

 Carolyn Troiano
 Recorded Webinar
 90 Minutes
 Download Catalog
Functional System Requirements for 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. Defining the functional re..

Showing 1 to 15 of 26 (2 Pages)