Courses

Computer System Validation ( CSV) 3 Day Seminar

Mar 23-25 3 day CSV course will teach you how to comply with key FDA and international CSV

Carolyn Troiano

$1,495

FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

Apr 09 The seminar will cover what you need to do to prepare for an FDA audit, and also the importance and steps required to be certain you have audited all vendors of regulated systems appropriately.

Carolyn Troiano

$499

Computer System Validation (CSV) Basics

Apr 21 The attendee will learn about FDA’s approach to modernizing technology, and how that will benefit both the Agency and industry

Carolyn Troiano

$189

Fundamentals of Part 11 Webinar

May 18 The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems

Carolyn Troiano

$189

Spreadsheet Validation Webinar

June 25 This webinar is intended for those involved in planning, execution and support of computer system validation activities, working

Carolyn Troiano

$189

Validation of FDA-Regulated Systems that Incorporate Artificial Intelligence (AI) and Machine Learning (ML)

MP3 Download In this webinar, you will learn just how AI can increase efficiency and effectiveness of software development life cycle

Carolyn Troiano

$249

Implementing CSA for GxP Systems - Transition, Documentation, and Post-Transition Challenges and Opportunities

MP3 Download Attendees will learn how to adapt their current method of validating FDA-regulated computer systems to align with both GAMP®5, Second Edition, published in July 2022,

Carolyn Troiano

$1,495

FDA Regulations for Tobacco & Tobacco-Related Products – Computer System Validation (CSV), 21 CFR Part 11 (electronic records/signatures), Data Integrity & Compliance

MP3 Download You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA

Carolyn Troiano

$199

Risk-Based Approach to IT Infrastructure Qualification, Compliance & Control

MP3 Download In this webinar, we’ll discuss on-premise servers and software, cloud-based services, and Software-as-a-Service (SaaS) solutions

Carolyn Troiano

$199

FDA Compliance and Clinical Trial Computer System Validation Core Requirements, Expectations and Challenges

MP3 Download In this two day Virtual Seminar you will learn about FDA's expectations for classifying, assessing the risk, testing, and validating a computer system used in clinical trial work.

Carolyn Troiano

$1,495

Computer System Validation for Cloud and COTS Applications–Live, Online Training

MP3 Download The attendee will learn about FDA’s approach to modernizing technology, and how that will benefit both the Agency and industry

Carolyn Troiano

$1,495

21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

MP3 Download The attendee will learn a simple way to address both data integrity and Part 11 aspects of the system, focusing on risk and critical thinking

Carolyn Troiano

$895

Introduction to Computer System Validation

MP3 Download This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology

Carolyn Troiano

$1,295

Computerized Systems Validation, Data Integrity & Cloud Computing In Pharma & Biotech

Aug 20-21 This Course will explain how to comply with key FDA and international CSV regulations

Carolyn Troiano

$1,495

GAMP® 5 Second Edition – The changes and its impacts that you should know

MP3 Download Attendees will learn how to adapt their current method of validating FDA-regulated computer systems to align with both GAMP®5, Second Edition

Carolyn Troiano

$499

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

MP3 Download 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

Carolyn Troiano

$495

All About Data Integrity by Design

MP3 Download The course provides insight into the ways in which Pharma 4.0™ will serve as an enabler for next generation medicinal products and new business cases for established products

Carolyn Troiano

$1,295

Audit Trails - Critical to Support FDA 21 CFR Part 11 and Data Integrity Compliance

MP3 Download You’ll learn an approach to both 21 CFR Part 11 and data integrity compliance understanding what FDA expects stakeholders in industry to do. There a few simple suggestions that can streamline validation activities related to all of these key areas.

Carolyn Troiano

$189

FDA Compliance and Laboratory Computer System Validation

MP3 Download This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco

Carolyn Troiano

$189

Current Trends in FDA Compliance and Enforcement for Regulated Computer Systems and Data

MP3 Download This webinar will focus on the key areas that are most important, including security and data integrity. Implementing and following the System Development Life Cycle (SDLC) methodology

Carolyn Troiano

$189

Risk-Based Validation of Spreadsheet Applications

MP3 Deownload This webinar is intended for those involved in planning, execution and support of computer system validation activities, working in the FDA-regulated industries

Carolyn Troiano

$189

Project Management for Computer System Validation (CSV) to Improve FDA Compliance

MP3 Download We will cover the approach for validating/qualifying infrastructure components to FDA-regulated systems, including cloud-based servers and Software-as-a-Service (SaaS) solutions

Carolyn Troiano

$189

Pharma 4.0 Focus - Newer Approaches and Technologies to Reduce Costs while Complying with FDA's 21 CFR Part 11, Data Integrity

MP3 Download The attendee will learn about ways to approach the computer system validation of any FDA-regulated system. There are traditional methods that have been followed for decades now, but these document-driven efforts

Carolyn Troiano

$189

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

MP3 Download This webinar will cover the key aspects of complying with 21 CFR Part 11 in both validating systems and maintaining them in a validated state throughout their entire life cycle.

Carolyn Troiano

$189

Validation of Artificial Intelligence (AI), Machine Language (ML), and other Superintelligence-Based Systems Regulated by FDA

MP3 Download During the webinar, we will discuss FDA's considerations for adapting its review process for AI-enabled medical devices that have the ability to evolve rapidly in response to new data

Carolyn Troiano

$189

Trial Master File and Clinical Data Management Regulated by FDA

MP3 Download This FDA compliance training will cover in detail the new requirements for trial master files

Carolyn Troiano

$189

FDA's Latest Guidance for Cybersecurity for Medical Devices: Quality Management System and Premarket Submission Considerations

MP3 Download This webinar will focus on cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products

Carolyn Troiano

$199

Traditional Computer System Validation and More Novel Computer Software Assurance (CSA): Finding the Best Approach

MP3 Download The attendee will learn about FDA’s approach to modernizing technology, and how that will benefit both the Agency and industry

Carolyn Troiano

$199

Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software

MP3 Download This webinar will include a comparison of the Agile and Waterfall methodologies, along with the pros and cons of each

Carolyn Troiano

$189

FDA Compliance and Enforcement Trends focused on Data Integrity

MP3 Download This course will enable you to best anticipate and prepare for FDA scrutiny, understand your role during inspections and audits

Carolyn Troiano

$249

FDA's Recent Regulation on the Use of Social Media - What It Is, How to Analyze It, Make It Work for You

MP3 Download 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

Carolyn Troiano

$249

Learn the Latest FDA Compliance and Mobile Applications Live Webinar

MP3 Download This topic is focused on the use of mobile applications to process data regulated by FDA. These applications may be used to collect, analyze

Carolyn Troiano

$299

Computer System Validation (CSV) vs. Computer Software Assurance (CSA): Following a Waterfall vs. Agile Methodology

MP3 Download The attendee will learn about FDA’s approach to modernizing technology, and how that will benefit both the Agency and industry.

Carolyn Troiano

$499

4 Hours Training Course on Medical Device Cybersecurity and FDA Compliance

This webinar will focus on cybersecurity of medical devices

Carolyn Troiano

$695

Data Integrity and Data Governance for Computer Systems Regulated by FDA

MP3 Download This webinar will help you understand in detail the application of FDA’s guidelines for Computer System Validation

Carolyn Troiano

$240

Risk-Based Approach to Part 11 Compliance and Policies and Procedures to Support GxPs

MP3 Download This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle

Carolyn Troiano

$392