Carolyn Troiano
IT/Business Leadership Professional
Carolyn Troiano has more than 35 years of experience in the pharmaceutical, medical device, tobacco and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs.
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Recorded Webinar
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 step further, we are now looking at ways to ensure the data that resides on these systems is also managed in a compliant manner and one that will provide the best results for operations at the lowest cost.
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The 6 Most Common Problems in FDA Software Validation and Verification, Computer System Validation: Step-by-Step
This seminar 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 maintained in a validated state throughout its entire life cycle, from conception through retirement.
Recorded Session Get life time access for one participant with download option!

How to go Paperless in an FDA-Regulated Environment using Electronic Workflow Signature Approvals and Electronic Records
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, in order to achieve a goal of going "paperless".
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Clinical Trial Master File Compliance
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 webinar will help you understand in detail the new requirements for trial master files.
Recorded Session Get life time access for one participant with download option!

In-Depth Testing of Computer Systems Regulated by FDA
The Webinar will focus on testing as a key element of Computer System Validation (CSV). The level of testing must reflect both the potential risk associated with failure of the system to function properly. It must also be based on the systems' classification in accordance with GAMP 5, and on a thorough risk assessment of what could happen if the system were to fail. A standard risk approach will be explained to incorporate into the testing to be done.
Recorded Session Get life time access for one participant with download option!

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 with specific rules.
Recorded Session Get life time access for one participant with download option!

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 step further, we are now looking at ways to ensure the data that resides on these systems is also managed in a compliant manner and one that will provide the best results for operations at the lowest cost.
Recorded Session Get life time access for one participant with download option!

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 with specific rules.
Recorded Session Get life time access for one participant with download option!

A Regulatory Perspective: FDA's New Guidance's Deciding When to Submit a 510(k) for Device & Software Changes
Control of medical device changes and a current 510(k) are big issues in recent FDA studies. Companies are held fully responsible for deciding when a new 510(k) filing is warranted. Often this is a difficult decision process. Effective change control and the power of current risk management tools must be a major part of such an analysis.
Recorded Session Get life time access for one participant with download option!

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 in a regulated environment. The use of electronic records and signatures enables a company to conduct business in a paperless environment. However, this is only if the company adheres to the specific requirements put forth by FDA in their guidance for ER/ES. The paperless environment means that all signatures will be obtained through a software-enabled workflow system that routes the key documents to specifically approved signers. The workflow typically includes tracking of the status of the document, indicating where it is in the approval process. It also allows for signers to reject a document and request that either it be withdrawn altogether or modified in some manner.<br/><br/>
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How to Apply for a Breakthrough Therapy Designation and Win It
This webinar, presented by a leading regulatory affairs expert with successful BTDs, discusses FDA expectations from BTD requests, the best practices to write a BTD request, and pros and cons of applying for a BTD. The session will highlight key regulatory requirements, dos and don'ts, common areas of concern, and trouble-shooting BTD requests using case studies and examples from the presenter's vast experience helping companies big and small in successfully applying for a BTD. The format and rules governing BTD request will be discussed along with success and challenge factors. The training is designed to provide a well-rounded training to all stakeholders in all aspects of the BTD application process.
Recorded Session Get life time access for one participant with download option!

Preparing for the Upcoming EU Medical Device Regulations
After years of negotiation, an agreement was reached by the European Council's Permanent Representatives Committee and the European Parliament's Environment and Health Committee in June 2016 on the new Medical Device (MD) and in vitro Diagnostic Device (IVDD) regulations. Two documents are planned for September 2016, and the Council and Parliament could adopt them by the end of the year. The new rules will go into effect three years after publication for medical devices and five years after publication for IVDs.
Recorded Session Get life time access for one participant with download option!

FDA's Two New Draft Guidance on Software and Device Changes and the 510(k)
This course is intended to provide an overview of 2 new FDA draft guidance documents that clarify when medical device and software manufacturers must file a 510(k) (premarket notification) for changes to an existing device and/or software integrated with a device.
Recorded Session Get life time access for one participant with download option!

Customs-Trade Partnership Against Terrorism (C-TPAT) and Supply Chain Security
You should attend this training if you have a role in a manufacturing or freight/shipping company that handles goods distributed globally. The training will help you secure the international supply chain and mitigate the risks associated with illegal activities that support and fund terrorism.
Recorded Session Get life time access for one participant with download option!

FDA's Low-Risk Device Policy and the Impact on Mobile Medical Device Applications
This webinar will provide the attendees with an overview of both FDA's Low-Risk Device Draft Policy (January 2015) and guidance on Mobile Medical Applications (February 2015), along with insight as to how companies can achieve compliance with both.
Recorded Session Get life time access for one participant with download option!

6 Most Common Problems in FDA Software Validation and Verification, Computer System Validation : 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 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 retirement. We will discuss the phases within the SDLC, and how these form the basis for any CSV project. The importance of the sequence of steps will also be covered.
Recorded Session Get life time access for one participant with download option!

Navigating FDA's Recent Regulation on the Use of Social Media
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.
Recorded Session Get life time access for one participant with download option!

Computer System Validation for Systems Supporting Clinical Trials
This webinar will help you understand in detail the requirements for validating a computer system that is used in support of conducting clinical trials in compliance with FDA’s Good Clinical Practices (GCP). The approach is based on standard Computer System Validation (CSV) and System Development Life Cycle (SDLC) methodologies, which employ an approach critical to FDA compliance.
Recorded Session Get life time access for one participant with download option!

21 CFR Part 11 (Electronic Records/Electronic Signatures)and FDA-Regulated Computer Systems
This webinar 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 validated state throughout its entire life cycle, from conception through retirement.
Recorded Session Get life time access for one participant with download option!

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. The areas covered in this webinar are:
Recorded Session Get life time access for one participant with download option!

Applying Computer System Validation to Mobile Applications
This webinar will discuss 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 retirement.
Recorded Session Get life time access for one participant with download option!

Policies and Procedures Required to Support Validation of Computer Systems Regulated by FDA
Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. This webinar will discuss in detail the categories and variety of policies and procedures required to support activities related to computer system validation for systems subject to FDA regulations.
Recorded Session Get life time access for one participant with download option!

Data Governance for FDA-Regulated Computer Systems
After attending this course, you will understand data governance as a quality control discipline for assessing, managing, using, improving, monitoring, maintaining, and protecting organizational information. It is a system of decision rights and accountabilities for information-related processes, executed according to agreed-upon models which describe who can take what actions with what information, and when, under what circumstances, and, finally, using what methods.
Recorded Session Get life time access for one participant with download option!

Business Process Re-engineering and FDA-Regulated Computer System Projects
This course will describe how to incorporate business process re-engineering into a project that includes a GxP (Good Manufacturing Practices, Good Laboratory Practices or Good Clinical Practices) system, meaning one that is regulated by the FDA. We will review the strategy and tactical approach for ensuring the maximum business benefits and achieving FDA compliance.
Recorded Session Get life time access for one participant with download option!

21 CFR Part 11 Electronic Records/Electronic Signature and FDA-Regulated Computer Systems
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 in a regulated environment.
Recorded Session Get life time access for one participant with download option!

Data Migration, Management and Archival in an FDA-Regulated Environment
This course is intended to provide specific guidelines for coaching attendees on the best practices for data migration, conversion, management and archival, including the handling of documentation.
Recorded Session Get life time access for one participant with download option!

Business Continuity Best Practices for an FDA-Regulated Environment
This course is intended to provide specific guidelines for coaching attendees on the business continuity best practices when systems and data fail, including the handling of documentation.
Recorded Session Get life time access for one participant with download option!

Disaster Recovery Best Practices for an FDA-Regulated Environment
This course is intended to provide specific guidelines for coaching attendees on the best practices for disaster recovery of systems and data, including the handling of documentation.
Recorded Session Get life time access for one participant with download option!

Best Practices for Developing Requirements for FDA-Regulated Systems
This course is intended to provide specific guidelines to attendees on the best practices for developing requirements for computer systems regulated by the FDA.
Recorded Session Get life time access for one participant with download option!

Contract Management for Vendors of FDA-Regulated Systems
This course is intended to provide specific guidelines for coaching attendees on the best practices for managing vendors, consultants and contractors involved in developing, delivering or implementing computer systems regulated by FDA.
Recorded Session Get life time access for one participant with download option!

How to Manage Compliance vs Cost for Systems Regulated by FDA
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, migration, integration, upgrade and retirement.
Recorded Session Get life time access for one participant with download option!

Legacy System Replacement in an FDA-Regulated Environment
This course is intended to provide specific guidelines for coaching attendees on the best practices for replacing a legacy system regulated by FDA, including the handling of data and documentation.
Recorded Session Get life time access for one participant with download option!

Organizational Change Management Best Practices for Systems Regulated by FDA
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, migration, integration, upgrade and retirement.
Recorded Session Get life time access for one participant with download option!

In-Depth Testing for Computer Systems Regulated by FDA
This course is intended to provide specific guidelines for developing an approach for in-depth testing of computer systems regulated by FDA. These include, but are not limited to system implementations, migrations, integrations, upgrades and retirement.
Recorded Session Get life time access for one participant with download option!

Project Management for Computer Systems Regulated by FDA
Project management principles can be used to ensure that all efforts to develop, configure, implement, test, validate and maintain a computer system is compliant.specific in terms of how this is to be done.
Recorded Session Get life time access for one participant with download option!

Legal, Regulatory and Policy Issues Related to Computer System Validation as the FDA Regulates Tobacco Products
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), specifically as it relates to the tobacco industry. Such a system must be validated in accordance with FDA guidelines for computerized systems and documented accordingly.
Recorded Session Get life time access for one participant with download option!

Best Practices for Auditing Computer System Vendors to Reduce Risk
This Webinar will discuss the importance of applying industry best practices when auditing a hardware, software, or other technology vendor, or a provider of technology services, such as system implementation, system configuration, system development, system integration or similar activity.
Recorded Session Get life time access for one participant with download option!

GAMP 5 and its Application to Computer System Categorization and Validation
We will discuss the importance of categorizing computerized systems used in the manufacture, testing and/or distribution of pharmaceutical, biological or medical device products in accordance with GAMP 5 standards. Classification of the system is key to determining the best strategy and requirements for validating the system and preparing the necessary supporting documentation.
Recorded Session Get life time access for one participant with download option!

Reducing Risk through Computer Vendor Audits
We will discuss the importance of applying industry best practices for reducing risk by conducting a thorough vendor audit of vendors producing hardware, software and other computerized components that are purchased and used by a company that is regulated by FDA. These systems and components must meet all requirements for computer system validation, as prescribed by FDA. As such, the vendor must assure that all of their processes for manufacturing and testing the systems and components will also meet FDA's criteria.
Recorded Session Get life time access for one participant with download option!

Best Practices for Documenting a Computer System Validation Process
We will discuss the importance of applying industry best practices when documenting 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.
Recorded Session Get life time access for one participant with download option!

Impact of Integration of Laboratory and Business 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 ERP or similar type of enterprise or supply-chain automation system. These are commonly integrated in manufacturing companies that use large-scale, enterprise-wide solutions for automating the production, testing and distribution processes in pharmaceutical, biotechnology, medical device or other related FDA-governed industries, and rely on data from laboratory systems to feed information about product quality and/or release.
Recorded Session Get life time access for one participant with download option!

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