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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 professional organizations.


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Showing 1 to 14 of 14 (1 Pages)
$200.00
21 CFR Part 11 (Electronic Records/ Signatures) Compliance for Computer Systems Regulated by FDA

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

This seminar will help you understand in detail the application of FDA’s 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems 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 ..

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

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

 Carolyn Troiano
 Recorded Webinar
 60 Minutes
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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
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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
In Depth Testing of Computer Systems Regulated by FDA

 Carolyn Troiano
 Recorded Webinar
 60 Minutes
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In Depth Testing 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. Testing is a very large co..

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

 Carolyn Troiano
 Recorded Webinar
 60 Minutes
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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
New FDA and EMA Labeling Requirements for Regulated Industries

 Carolyn Troiano
 Recorded Webinar
 90 Minutes
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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
Trial Master File – Clinical Data Systems

 Carolyn Troiano
 Recorded Webinar
 90 Minutes
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Trial Master File – Clinical Data Systems

Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content, and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF). This seminar will help you understand in detail the new requirements for trial ..

$200.00
Data Governance for Computer Systems Regulated by FDA

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

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

 Carolyn Troiano
 Recorded Webinar
 90 Minutes
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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
Medical Device Software 62304 Compliance

 Carolyn Troiano
 Recorded Webinar
 90 minutes
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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
FDA Compliance and Clinical Trial Computer System Validation

 Carolyn Troiano
 Recorded Webinar
 90 Minutes
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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
Good Documentation Practices (GDPs) to Support FDA-Regulated Computer System Validation (CSV)

 Carolyn Troiano
 Recorded Webinar
 90 Minutes
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Good Documentation Practices (GDPs) to Support FDA-Regulated Computer System Validation (CSV)

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.Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems..

Showing 1 to 14 of 14 (1 Pages)