Carolyn Troiano
Carolyn Troiano
Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco 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 back in the mid-1980s, when the first FDA guidebook was published on the subject, 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. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.
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3-Hour Virtual Seminar on GAMP® 5 Second Edition – The changes and its impacts that you should know
With GAMP®5, published in 2008, this guide became the globally accepted standard for the validation of computerized systems. Due to new technological (Artificial Intelligence / Cloud Computing / Agile Software Development) and regulatory developments (ICH Q9 / FDA initiative... -
Data Integrity by Design, Pharma 4.0 and Overcoming DI issues in the Cloud
Data Integrity by Design is the concept that data integrity must be incorporated from the initial planning of a business process through to the implementation, operation, and retirement of computerized systems supporting that business process. It promotes the application... -
6-Hour Virtual Seminar on Computer System Validation for Cloud and COTS Applications
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... -
2-Day Virtual Seminar on Computer System Validation (CSV) and Data Integrity for Clinical Trials Regulated by FDA
Computer system validation has been regulated by FDA for more than 30 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... -
3-Hour Virtual Seminar on Computer System Validation (CSV) vs Computer Software Assurance (CSA) – Following a Waterfall vs Agile Methodology
As part of the Case for Quality program US FDA Center for Devices and Radiological Health noted how an excessive focus by industry on compliance rather than quality may be diverting resources and management attention toward meeting regulatory compliance... -
Expediting Approval for Regenerative Drugs and Breakthrough Therapy Designation
FDA provides 4 programs for accelerated drug approval, each with a specific set of requirements and considerations. Drugs must be for serious conditions that fill an unmet medical need and can be approved based on a surrogate endpoint, or... -
SDLC Modernization Continuous Quality in an FDA-Regulated Environment and Journey to Paperless SDLC/CSV
Areas Covered in the Session : Learn how to identify “GxP” Systems Discuss the current state of Computer System Validation (CSV) approach based on FDA requirements Learn about the System Development Life Cycle (SDLC) approach to validation and how... -
Master the Vendor Auditing of your Computer Systems Regulated by FDA
This webinar will provide the best industry practices to follow when auditing a vendor of a computer system that is regulated by FDA. We will discuss the best approach for assessing a vendor’s organization, capability, physical/logical security practices, requirements,... -
How Will FDA’s New Approach to CSV Make Implementations Easier?
There is a big shift in the computer system validation (CSV) strategy coming from the FDA. The new methodology and guidance called Computer System Assurance (CSA) could be in place before January 2021. Its focus is taking the principles... -
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Medical Device Cybersecurity and FDA Compliance – How to Avoid Your Medical Device Being Hacked
This seminar will focus on cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products. Protecting medical devices from hacking where someone can alter the actual code embedded in the device could... -
Trial Master File (TMF) – Clinical Trial Systems and FDA Expectations
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... -
4-Hour Virtual Seminar on Risk-Based Approach to Part 11 Compliance and Policies and Procedures to Support GxPs
Computer system validation (CSV) 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 has been regulating CSV for more than 30 years now.... -
FDA’s Recent Regulation on the Use of Social Media
This seminar 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... -
4-Hours Virtual Seminar – Medical Device Cybersecurity and FDA Compliance
This seminar will focus on cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products. Protecting medical devices from hacking where someone can alter the actual code embedded in the device could... -
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4-Hour Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries
Electronic record/electronic signature (ER/ES) capabilities are extremely important and should be built into FDA-regulated computer systems to meets compliance with 21 CFR Part 11. This webinar will help you to strategize the development of a company philosophy and approach,... -
Applying Computer System Validation to Mobile Applications
Mobile applications can be validated as per FDA regulations using the same principles of computer system validation. For this to be compliant, development of an appropriate validation strategy to achieve the diligence required to prove that a system does... -
4-Hour Virtual Seminar on Computer System Validation (CSV) and Data Integrity for Clinical Trials Regulated by FDA
Computer systems used in conducting clinical trials must be evaluated to determine the level of compliance, established on validation and data integrity. We will walk through the entire System Development Life Cycle (SDLC) approach to validation of FDA-regulated computer... -
FDA Compliance and Laboratory Computer System Validation
You should attend this seminar if you are responsible for planning, executing or managing the validation of laboratory computer systems governed by FDA regulations. Effective and compliant computer system validation is critical to any FDA-regulated organization. During the past... -
How to Apply for a Breakthrough Therapy Designation and Win It
One of the most impact incentives from the FDA is the Breakthrough Therapy Designation (BTD). It helps in getting the product/drug to market much faster than any other expedited approval pathway. The application processes for Breakthrough Therapy Designation need... -
Data Governance for Computer Systems Regulated by FDA
Organizations governed by FDA must adhere to strict requirements relative to data being captured, analyzed, reported or stored on computer systems. As such, organizations must be able to manage the data effectively, realize value from it, minimize the cost,... -
3-Hour Virtual Seminar on Best Practices to Help you Pass an FDA Computer System Validation Audit
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... -
In Depth Testing of Computer Systems Regulated by FDA
Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. 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... -
Current Trends in CyberSecurity Threats to Medical Devices
This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats. Cybersecurity is a serious concern for medical device safety and effectiveness.... -
Good Documentation Practices to Support Computer System Validation
Computer system validation has been regulated by FDA for more than 30 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... -
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... -
3 Hours Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries
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... -
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Tobacco Industry Trends for Computer Systems Regulated by FDA
Get an overview of the regulations as they pertain to the manufacturing, marketing, distribution and other operational activities engaged by companies in the tobacco industry. This course will describe the best practices for developing a compliance strategy, including roles... -
3-Hours Virtual Seminar – Medical Device Cybersecurity and FDA Compliance
This seminar will focus on cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products. Protecting medical devices from hacking where someone can alter the actual code embedded in the device could... -
FDA and EMA Global Labeling Challenges and Requirements
Pharmaceutical companies should manage the process of designing and creating product labels meeting regulatory requirements. It includes product-labeling documents such as Summaries of Product Characteristics (SmPCs), Packet Inserts (PIs), and Core Data Sheets (CDSs). A large number of dosage... -
Good Documentation Practices to Support Computer System Validation
Computer system validation has been regulated by FDA for more than 30 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... -
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Project Management Best Practices for Computer Systems Regulated by FDA
We will discuss the importance of applying industry best practices when managing projects involving development, configuration, implementation, testing, validation and other System Development Life Cycle (SDLC) phases for any IT system used in an FDA-regulated environment (i.e., the system... -
FDA Computer System Audit – Best Preparation Practices
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... -
Latest FDA and EMA Global Labeling Challenges and Requirements
Pharmaceutical companies should manage the process of designing and creating product labels meeting regulatory requirements. It includes product-labeling documents such as Summaries of Product Characteristics (SmPCs), Packet Inserts (PIs), and Core Data Sheets (CDSs). A large number of dosage... -
System Development Life Cycle (SDLC) Methodology and FDA-Regulated Systems
This webinar will discuss the System Development Life Cycle (SDLC) Methodology and the importance of following this approach when validating computer systems subject to FDA regulations. Upon completion of this session, attendees will have an understanding of how to... -
How to go Paperless in an FDA-Regulated Environment using Electronic Workflow Signature Approvals and Electronic Records
This course is intended to provide specific guidelines for coaching attendees in the concepts of 21 CFR Part 11, namely the FDA requirements for using electronic records and electronic signatures (ER/ES), and the best practices for implementing these technologies... -
Organizational Change Management for FDA Regulated Computer Systems
This course is intended to provide specific guidelines for coaching attendees on the best practices for creating organizational change as it relates to computer systems regulated by FDA. These include, but are not limited to system implementation, testing, validation,... -
Most Common Challenges in FDA Software Validation and Verification, Computer System Validation and Overcoming them: Step-by-Step
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... -
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FDA’s Recent Regulation on the Use of Social Media
This seminar will help you understand in detail the application of FDA’s latest 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... -
Best Practices in Preparation for an FDA Computer System Audit
The Webinar will discuss the importance of preparing for and participating in a computer system validation audit by regulatory agencies. Regulatory agencies fully expect companies to comply with the computer system validation guidelines that were established in 1983 and... -
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Customs – Trade Partnership Against Terrorism (C-TPAT) and Supply Chain Security
The Customs-Trade Partnership Against Terrorism (C-TPAT) is a voluntary supply chain security program led by U.S. Customs and Border Protection (CBP). It is intended to improve the security of supply chains of private enterprises against the threat of terrorism.... -
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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... -
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Project Management Best Practices for Computer Systems Regulated by FDA
We will discuss the importance of applying industry best practices when managing projects involving development, configuration, implementation, testing, validation and other System Development Life Cycle (SDLC) phases for any IT system used in an FDA-regulated environment (i.e., the system... -
Sale!
FDA Compliance and Laboratory Computer System Validation
You should attend this seminar if you are responsible for planning, executing or managing the validation of laboratory computer systems governed by FDA regulations. Effective and compliant computer system validation is critical to any FDA-regulated organization. During the past... -
FDA Labeling Requirements – New Regulations
Pharmaceutical companies must manage the process of designing and creating product labels that meet regulatory requirements. This includes product-labeling documents such as Packet Inserts (PIs), Summaries of Product Characteristics (SmPCs) and Core Data Sheets (CDSs). The large number of... -
Sale!
Integration of Enterprise Requirements Planning (ERP) and Legacy FDA-Regulated Systems
We will discuss the importance of applying industry best practices when planning, executing and validating the integration of a laboratory system (Laboratory Automation System (LAS), Laboratory Information Management System (LIMS), eNotebook, etc.) with a business system, such as an... -
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Pharmaceutical Trends for Computer Systems Regulated by FDA
The Webinar will focus on the importance of managing FDA oversight of computer system validation in the pharmaceutical industry by anticipating and preparing for trends. The type and extent of oversight varies with changes to the economic, political, and... -
Data Governance for Computer Systems Regulated by FDA
Organizations governed by FDA must adhere to strict requirements relative to data being captured, analyzed, reported or stored on computer systems. As such, organizations must be able to manage the data effectively, realize value from it, minimize the cost,... -
Data Governance for Computer Systems Regulated by FDA
Organizations governed by FDA must adhere to strict requirements relative to data being captured, analyzed, reported or stored on computer systems. As such, organizations must be able to manage the data effectively, realize value from it, minimize the cost,... -
FDA Compliance and Laboratory Computer System Validation
You should attend this seminar if you are responsible for planning, executing or managing the validation of laboratory computer systems governed by FDA regulations. Effective and compliant computer system validation is critical to any FDA-regulated organization. During the past... -
Medical Device Industry Trends for Computer Systems Regulated by FDA
This Webinar will focus on the importance of managing FDA oversight of computer system validation in the medical device industry by anticipating and preparing for trends. The type and extent of oversight varies with changes to the economic, political,... -
Best Practices in Preparation for an FDA Computer System Audit
The Webinar will discuss the importance of preparing for and participating in a computer system validation audit by regulatory agencies. Regulatory agencies fully expect companies to comply with the computer system validation guidelines that were established in 1983 and... -
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... -
Tobacco Industry Trends for Computer Systems Regulated by FDA
We will discuss the importance of applying industry best practices when validating systems and applications used in the tobacco industry, as regulated by FDA. This includes system development, configuration, implementation, testing, validation and other System Development Life Cycle (SDLC)... -
FDA Compliance and GAMP V Computer System Classification
You should attend this seminar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system. We will discuss the importance of... -
Combination Drug/Device Products cGMPs – Final Rule
Description: This training on combination product regulations will evaluate the chief areas of concern or change in the new cGMP requirements for combination products, 21 CFR Part 4, and clarify many of the issues and questions that arise involving... -
Tobacco Industry Trends for Computer Systems Regulated by FDA
Description: We will discuss the importance of applying industry best practices when validating systems and applications used in the tobacco industry, as regulated by FDA. This includes system development, configuration, implementation, testing, validation and other System Development Life Cycle... -
FDA Compliance and GAMP V Computer System Classification
Description: You should attend this seminar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system. We will discuss the importance... -
FDA Compliance and GAMP V Computer System Classification
Description: You should attend this seminar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system. We will discuss the importance... -
Combination Drug/Device Products cGMPs – Final Rule
Description: This training on combination product regulations will evaluate the chief areas of concern or change in the new cGMP requirements for combination products, 21 CFR Part 4, and clarify many of the issues and questions that arise involving... -
Tobacco Industry Trends for Computer Systems Regulated by FDA
Description: We will discuss the importance of applying industry best practices when validating systems and applications used in the tobacco industry, as regulated by FDA. This includes system development, configuration, implementation, testing, validation and other System Development Life Cycle...
