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Medical device Training (78)
FDA Regulatory Compliance Training (228)
Pharma Courses & Pharmaceutical Training (202)
Biotechnology Online Courses and Training (178)
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Virtual Seminars (63)
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Author:
Carolyn Troiano
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Alan Golden
Amanda McFarland
Andrew Campbell
Angela Bazigos
Barry A. Friedman
Ben Marandi
Carl Patterson
Carolyn Troiano
Casper (Cap) Uldriks
Charity Ogunsanya
Charles H. Paul
Cynthia Brysch
Danielle DeLucy
David Jones
David L. Chesney
David Nettleton
David R. Dills
David W. Husman
Dr. Afsaneh Motamed Khorasani
Dr. John M. Ryans
Dr. Michael Abitz
Dr. Stefano Persiani
Edwin Waldbusser
Elaine Eisenbeisz
Frank Stein
Ginette Collazo
Graeme Ladds
Jan Seal
Jeff Kasoff
Jim Sheldon-Dean
Joanna Brougher
John C. Fetzer
John E Lincoln
John G. Lanese
Jose Mora
Jose Mora
Joy L. McElroy
Karl M. Nobert
Kelly Eisenhardt
Kelly Thomas
Lisa Hardwick Thompson
Mark Brengelman
Mark Hughes
Mark Powell
Martin K. Behr
Meena Chettiar
Michael Esposito
Michael Ramcharan
Nancy Knettell
Nissan Cohen
Paolo Giacomoni
Paul Larocque
Peggy J. Berry
Peter Reijntjes
Rita Hoffman
Rob MacCuspie
Roger Cowan
Ron Snee
Speaker
Speaker for Biotechnology
Steve Jolley
Steven Laurenz
Steven Wachs
Susanne Manz
Theodore Sand
Tim Fischer
Todd Graham
Travis Austin MacKay
Trisha Paul
William Mack Copeland
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Find a product
Carolyn Troiano
Courses
Computer System Validation ( CSV) 3 Day Seminar
Available until
Nov 4-6 3 day CSV course will teach you how to comply with key FDA and international CSV
Carolyn Troiano
%
COMPLETE
$1,895
Audit Trails - Critical to Support FDA 21 CFR Part 11 and Data Integrity Compliance
Available until
21 Nov 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
%
COMPLETE
$189
Risk-Based Approach to IT Infrastructure Qualification, Compliance & Control
Available until
Dec 04 In this webinar, we’ll discuss on-premise servers and software, cloud-based services, and Software-as-a-Service (SaaS) solutions
Carolyn Troiano
%
COMPLETE
$189
All About Data Integrity by Design
Available until
09-10 Dec 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
%
COMPLETE
$1,295
Validation of FDA-Regulated Systems that Incorporate Artificial Intelligence (AI) and Machine Learning (ML)
Available until
Dec 09 In this webinar, you will learn just how AI can increase efficiency and effectiveness of software development life cycle
Carolyn Troiano
%
COMPLETE
$287
FDA Compliance and Laboratory Computer System Validation
Available until
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
%
COMPLETE
$189
Current Trends in FDA Compliance and Enforcement for Regulated Computer Systems and Data
Available until
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
%
COMPLETE
$189
FDA Trends for Computer System Validation (CSV) Compliance and Enforcement
Available until
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
%
COMPLETE
$499
Risk-Based Validation of Spreadsheet Applications
Available until
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
%
COMPLETE
$189
Computerized Systems Validation, Data Integrity & Cloud Computing In Pharma & Biotech
Available until
MP3 Download This Course will explain how to comply with key FDA and international CSV regulations
Carolyn Troiano
%
COMPLETE
$1,895
Project Management for Computer System Validation (CSV) to Improve FDA Compliance
Available until
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
%
COMPLETE
$189
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
Available until
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
%
COMPLETE
$499
Pharma 4.0 Focus - Newer Approaches and Technologies to Reduce Costs while Complying with FDA's 21 CFR Part 11, Data Integrity
Available until
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
%
COMPLETE
$189
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
Available until
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
%
COMPLETE
$189
FDA Compliance and Clinical Trial Computer System Validation Course
Available until
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
%
COMPLETE
$1,895
Validation of Artificial Intelligence (AI), Machine Language (ML), and other Superintelligence-Based Systems Regulated by FDA
Available until
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
%
COMPLETE
$189
Trial Master File and Clinical Data Management Regulated by FDA
Available until
MP3 Download This FDA compliance training will cover in detail the new requirements for trial master files
Carolyn Troiano
%
COMPLETE
$189
Achieving Compliance for FDA-Regulated Systems by Following Principles of CSA and GAMP®5 Second Edition
Available until
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
%
COMPLETE
$199
FDA's Latest Guidance for Cybersecurity for Medical Devices: Quality Management System and Premarket Submission Considerations
Available until
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
%
COMPLETE
$199
Traditional Computer System Validation and More Novel Computer Software Assurance (CSA): Finding the Best Approach
Available until
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
%
COMPLETE
$199
Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software
Available until
MP3 Download This webinar will include a comparison of the Agile and Waterfall methodologies, along with the pros and cons of each
Carolyn Troiano
%
COMPLETE
$189
Learn the Latest FDA Compliance and Mobile Applications Live Webinar
Available until
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
%
COMPLETE
$299
4 Hours Training Course on Medical Device Cybersecurity and FDA Compliance
Available until
This webinar will focus on cybersecurity of medical devices
Carolyn Troiano
%
COMPLETE
$695
Data Integrity and Data Governance for Computer Systems Regulated by FDA
Available until
MP3 Download This webinar will help you understand in detail the application of FDA’s guidelines for Computer System Validation
Carolyn Troiano
%
COMPLETE
$240
Best Practices for Equipment Validation, Tracking, Calibration, and Preventive Maintenance
Available until
MP3 Download This training will provide valuable assistance in process development include in Equipment Validation, Tracking, Calibration, and Preventive
Carolyn Troiano
%
COMPLETE
$179
Learn the latest Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance Webinar
Available until
MP3 Download Duration 90 Minutes
Carolyn Troiano
%
COMPLETE
$199
Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA
Available until
MP3 Download Duration 90 Minutes
Carolyn Troiano
%
COMPLETE
$199
21 CFR Part 11 Compliance for Computer Systems Regulated by FDA
Available until
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
%
COMPLETE
$199
Best Practices To Help You Pass An FDA Computer System Validation Audit
Available until
MP3 Download Duration 90 Minutes
Carolyn Troiano
%
COMPLETE
$199
FDA’s Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data
Available until
MP3 Download Duration 90 Minutes
Carolyn Troiano
%
COMPLETE
$199
Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall
Available until
MP3 Download Duration 90 Minutes
Carolyn Troiano
%
COMPLETE
$299
FDA's Recent Regulation on the Use of Social Media
Available until
MP3 Download -Duration 90 Minutes
Carolyn Troiano
%
COMPLETE
$199
Trends in FDA Compliance and Enforcement for Regulated Computer Systems
Available until
MP3 Download Duration 90 Minutes
Carolyn Troiano
%
COMPLETE
$199
Current regulatory thinking on Data Integrity in 2020
Available until
MP3 Download Duration 2 Days
Carolyn Troiano
%
COMPLETE
$1,495
What should you know about the Clinical Trial Master File Compliance : A REFRESHER
Available until
MP3 Download - Duration 90 Minutes
Carolyn Troiano
%
COMPLETE
$179
Medical Device Software 62304 Compliance
Available until
MP3 Download Duration 90 Minutes
Carolyn Troiano
%
COMPLETE
$229
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