Courses

Computer System Validation ( CSV) 3 Day Seminar

Nov 4-6 3 day CSV course will teach you how to comply with key FDA and international CSV

Carolyn Troiano

$1,895

All About Data Integrity by Design

27-28 Nov 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

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

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

MP3 Download The webinar 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

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

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

MP3 Download This Course will explain how to comply with key FDA and international CSV regulations

Carolyn Troiano

$1,895

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

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

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

$499

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

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

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

$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

FDA Compliance and Clinical Trial Computer System Validation Course

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

$1,895

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

$287

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

Achieving Compliance for FDA-Regulated Systems by Following Principles of CSA and GAMP®5 Second Edition

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

$199

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

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

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

Best Practices for Equipment Validation, Tracking, Calibration, and Preventive Maintenance

MP3 Download This training will provide valuable assistance in process development include in Equipment Validation, Tracking, Calibration, and Preventive

Carolyn Troiano

$179

Learn the latest Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance Webinar

MP3 Download Duration 90 Minutes

Carolyn Troiano

$199

Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA

MP3 Download Duration 90 Minutes

Carolyn Troiano

$199

21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

MP3 Download This webinar will help you understand in detail the application of FDA’s 21 CFR Part 11 guidance on electronic records

Carolyn Troiano

$199

Best Practices To Help You Pass An FDA Computer System Validation Audit

MP3 Download Duration 90 Minutes

Carolyn Troiano

$199

FDA’s Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data

MP3 Download Duration 90 Minutes

Carolyn Troiano

$199

Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall

MP3 Download Duration 90 Minutes

Carolyn Troiano

$299

FDA's Recent Regulation on the Use of Social Media

MP3 Download -Duration 90 Minutes

Carolyn Troiano

$199

Trends in FDA Compliance and Enforcement for Regulated Computer Systems

MP3 Download Duration 90 Minutes

Carolyn Troiano

$199

Current regulatory thinking on Data Integrity in 2020

MP3 Download Duration 2 Days

Carolyn Troiano

$1,495

What should you know about the Clinical Trial Master File Compliance : A REFRESHER

MP3 Download - Duration 90 Minutes

Carolyn Troiano

$179

Medical Device Software 62304 Compliance

MP3 Download Duration 90 Minutes

Carolyn Troiano

$229