The FDA recently released a new draft guidance related to Part 11

Feb 09 The attendee will learn about FDA’s approach to modernizing technology, and how that will benefit both the Agency and industry.

Carolyn Troiano

$299

Data Integrity by Design, Pharma 4.0 and Overcoming DI issues in the Cloud

Mar 07 This webinar will show how exactly is Data Integrity by Design important for achieving Pharma 4.0 and how its implementation can overcome issues of cloud computing.

Carolyn Troiano

$249

Introduction to Computer System Validation

Feb 27 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

$795

Trial Master File and Clinical Data Management Regulated by FDA

Mar 15 This FDA compliance training will cover in detail the new requirements for trial master files

Carolyn Troiano

$199

All About Data Integrity by Design

April 13-14 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

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

May 03-05 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, FDA's Guidance for Electronic Records and Electronic Signatures

MP3 Download 21 CFR Part 11, FDA's Guidance for Electronic Records and Electronic Signatures

Carolyn Troiano

$249

Computer System Validation (CSV) and Data Integrity for Clinical Trials Regulated by FDA

MP3 Download we will discuss what is needed to prepare for an FDA inspection of computer systems and data used in support of clinical trials.

Carolyn Troiano

$1,495

SDLC Modernization Continuous Quality in an FDA-Regulated Environment and Journey to Paperless SDLC/CSV

MP3 Download This Webinar provide an overview of industry best practices, with a focus on data integrity and risk assessment that can be leveraged to assist in all your GxP work.

Carolyn Troiano

$249

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

$1,295

Computer System Validation ( CSV) 3 Day Seminar

MP3 Download 3 day CSV course will teach you how to comply with key FDA and international CSV regulations and guidance, such as 21 CFR Part 11 and Annex 11.

Carolyn Troiano

€1.495

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

MP3 Download This course will provide a condensed overview of the key practices that deliver the best results by directing the attendees

Carolyn Troiano

$249

Trial Master File (TMF) – Clinical Trial Systems and FDA Expectations

MP3 Download This webinar will help you understand in detail the new requirements for trial master files. You should attend this webinar if you are responsible for establishing or maintaining a TMF

Carolyn Troiano

$249

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 Computer System Validation ( CSV) Training 3 Days Virtual Seminar

MP3 Download This Course will explain how to comply with key FDA and international CSV regulations and guidance, such as 21 CFR Part 11 and Annex 11.

Carolyn Troiano

$1,895

Computer System Validation for Cloud and COTS Applications

May 03-05 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

FDA Compliance and Mobile Applications Best Practices for Ensuring Compliance

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

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

Medical Device Cybersecurity: What You Need to Know

MP3 Download In this webinar, you will learn just how cyberattacks threaten medical devices and how industry is currently responding to them

Carolyn Troiano

$249

Computer Software Assurance (CSA) Approach to Validation: Using Agile and Automated Testing

MP3 Download Computer Software Assurance (CSA) Approach to Validation: Using Agile and Automated Testing

Carolyn Troiano

$249

Best Practices in Preparation for an FDA Computer System Audit

MP3 Download The Webinar will discuss the importance of preparing for and participating in a computer system validation audit by regulatory agencies. Regulatory agencies fully expect companies

Carolyn Troiano

$249

Computer System Validation Professional Certification Program 3 Days

MP3 Download The course moves quickly and participants will change gears often to keep interest high and accommodate multiple learning styles

Carolyn Troiano

$1,295

A risk based approach to GxP Compliant Laboratory Computerized Systems in the COVID-19 Era and Beyond

MP3 Download This hands-on seminar provides a practical, risk based approach to laboratory computerized system specification, verification, and implementation

Carolyn Troiano

$1,295

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

Computer System Validation Boot Camp®

The course moves quickly and participants will change gears often to keep interest high and accommodate multiple learning styles

Carolyn Troiano

€2.800

Medical Device Cybersecurity and FDA Compliance

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

$695

Computer System Validation Professional Certification Program 3 Days

Dec 8-10 , 2021 This course will completely immerse you in computer system validation and delivers comprehension of the regulations impacting your system

Carolyn Troiano

€1.295

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

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

Virtual Seminar on GAMP® Data Integrity 21 CFR Part 11 Training Course

MP3 Download This training course will provide a practical understanding of the requirement for a data governance framework

Carolyn Troiano

$695

QA and Risk Management approaches when Managing Clinical Trial Data – New Course !

MP3 Download This presentation focuses on the role of QA in the Risk Management process when deciding on how data should be collected

Carolyn Troiano

$229

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