• Your shopping cart is empty!

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.


Product Compare (0)
Showing 1 to 15 of 23 (2 Pages)
$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 Audit

 Carolyn Troiano
 Recorded Webinar
 90 Minutes
 Download Catalog
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 ..

$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
C-TPAT Compliance for FDA Regulated Industries

 Carolyn Troiano
 Recorded Webinar
 90 Minutes
 Download Catalog
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 pro..

$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..

$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..

Showing 1 to 15 of 23 (2 Pages)