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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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Showing 16 to 26 of 26 (2 Pages)
$200.00
Functional System Requirements Planning for Computer Systems Regulated by FDA

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

 Carolyn Troiano
 Recorded Webinar
 90 Minutes
 Download Catalog
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..

$200.00
How Successfully Apply for a Breakthrough Therapy Designation

 Carolyn Troiano
 Recorded Webinar
 60 Minutes
 Download Catalog
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
 Download Catalog
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
 Download Catalog
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
Medical Device Software 62304 Compliance

 Carolyn Troiano
 Recorded Webinar
 90 minutes
 Download Catalog
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
New FDA and EMA Labeling Requirements for Regulated Industries

 Carolyn Troiano
 Recorded Webinar
 90 Minutes
 Download Catalog
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
Tobacco Industry Trends for Computer Systems Regulated by FDA

 Carolyn Troiano
 Recorded Webinar
 90 Minutes
 Download Catalog
Tobacco Industry Trends for Computer Systems Regulated by FDA

The Tobacco Control Act went into effect by the FDA on June 22, 2009. Through this ruling, the FDA regulated cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco, but in 2016, the FDA finalized a rule, Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, which extends the FDA’s authority to include the regulation of electronic nicotine delivery systems (..

$200.00
Trial Master File – Clinical Data Systems

 Carolyn Troiano
 Recorded Webinar
 90 Minutes
 Download Catalog
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
Writing World Class Compliance Documentation

 Carolyn Troiano
 Recorded Webinar
 60 Minutes
 Download Catalog
Writing World Class Compliance Documentation

Standard operating procedures and work instructions can be an effective tool in the control and standardization of operations, the conduct of training, the meeting of all regulatory requirements, and as user support tools to guide individual performance and to manage the execution of that performance. The key is in knowing how to apply the proper techniques to their creation.Standard Operating Procedures an..

$200.00
Developing A Strategic Approach To FDA Compliance For Computer Systems

 Carolyn Troiano
 Recorded Webinar
 90 Minutes
 Download Catalog
Developing A Strategic Approach To FDA Compliance For Computer Systems

This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating 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 ma..

Showing 16 to 26 of 26 (2 Pages)