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.
Carolyn Troiano
May 15 2024
03 : 00 PM EST
90 Minutes
GAMP®5, 2nd Edition and Alignment with FDA’s Draft Guidance for Computer Software Assurance (CSA)
Gain an understanding of how newer technology should be handled when performing validation work. A different approach will be covered during the session.We will also discuss best industry practices to ensure all systems, including technology that has been around for decades, yet until recently, these were rarely used in the life science industry. (e.g., cloud, Software-as-a-Service (SaaS), Electronic Record..
Carolyn Troiano
June 14 2024
03 : 00 PM EST
90 Minutes
Pharma 4.0: Next Generation Technology Approach to GxP Products, Systems, Data, & FDA Compliance
Computer system validation has been regulated by FDA for more than 40 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 FDA requirements ensure thorough planning, implementation, integration, testing and management of computer systems used to collect, analyze and/or rep..
Carolyn Troiano
July 10 2024
03 : 00 PM EST
90 Minutes
Data Privacy: California Privacy Rights Act (CPRA), Health Information Portability & Accountability Act (HIPAA), and General Data Protection Regulation (GDPR)
During this webinar, in addition to learning about the California privacy rules, we will discuss the Health Information Portability and Accountability Act (HIPAA) in the US and the General Data Protection Regulation (GDPR) that is in effect to protect citizens’ personal data when they reside in the European Union (EU). We will compare and contrast these with the CPRA, providing specific requirements and how..
Carolyn Troiano
August 05 2024
03 : 00 PM EST
90 Minutes
COTS, Cloud, and SaaS Systems and FDA Validation Compliance
“How can we perform an Installation Qualification (IQ) when the server is completely under the control of a vendor?”“How do we know the vendor will be able to manage security, backups, disaster recovery, and other aspects required to ensure data is collected and maintained with integrity?”“What about change control?”“How will we handle compliance with 21 CFR Part 11, FDA’s guidance for electronic records an..
Carolyn Troiano
September 11 2024
03 : 00 PM EST
90 Minutes
Clinical Trial Systems: Trial Master File (TMF) and eTMF, & FDA’s Recent Draft Guidance for Electronic Records/Signatures Used in Clinical Trials
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). All of the data and documents supporting the planning, conduct and e..
Carolyn Troiano
October 16 2024
03 : 00 PM EST
90 Minutes
Trends in FDA Compliance and Enforcement for Regulated Systems
FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC and 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 systems that are validated and subject to inspection and audit.As a “GxP” system, following Good Manufacturing, Laboratory and Clinical Practices, the ..
Carolyn Troiano
November 13 2024
03 : 00 PM EST
90 Minutes
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 ..
Carolyn Troiano
December 11 2024
03 : 00 PM EST
90 Minutes
Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA
FDA has substantial authority to oversee regulated companies and their operations. The primary purpose for FDA is to assure safe and effective products that will protect public health. Violations can have seriously adverse effects on products, and ultimately, on patients and consumers.The root of every company’s effort to defend their practices and products is through data and documentation, mea..
Carolyn Troiano
January 21 2025
11 : 30 AM EST
180 Minutes
Computer System Validation (CSV) Boot Camp (3-day intensive training)
We will explore the best practices and strategic approach for evaluating computer systems used in the conduct FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety. We will walk through the System Development Life Cycle (SDLC) approach to validation, based on risk assessment, and will also dis..
Carolyn Troiano
February 06 2025
03 : 00 PM EST
90 Minutes
Data Integrity and Privacy: 21 CFR Part 11, Annex 11, and General Data Protection Regulation (GDPR)
In this webinar, we will explore the best practices and strategic approach for evaluating computer systems used in the conduct of FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety.We will discuss traditional CSV vs. CSA, the draft guidance issued in September 2022 by FDA, indicating the differen..
Carolyn Troiano
Recorded Webinar
90 Minutes
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 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 CoveredCompu..
Carolyn Troiano
Recorded Webinar
90 Minutes
Computer System Validation (CSV) And Software Testing: Applying An Agile Methodology vs. Waterfall For FDA-Regulated Computer Systems And Software
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 and tools must change to meet these challenges. The approach to developing software, performing validation, and maintaining a sy..
Carolyn Troiano
Recorded Webinar
90 Minutes
FDA Guidance on the Use of Social Media: Know Your Responsibilities and Potential Liabilities
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.Areas CoveredPros and cons of using social media venuesCompliant use of Social Media i..
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..
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 ..