CAROLYN TROIANO - Eventura

21 CFR Part 11 Data Integrity Training for SaaS/Cloud, EU GDPR - How to Reduce Costs for Compliance

CAROLYN TROIANO

PRE-REGISTRATION AVAILABLE If you want to have this training scheduled Live and Exclusively for your company, we will arrange it for you. Pre-Register now and pay only once the training is scheduled on your preferred days. Click on the button below to pre-register

21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

CAROLYN TROIANO

PRE-REGISTRATION AVAILABLE If you want to have this training scheduled Live and Exclusively for your company, we will arrange it for you. Pre-Register now and pay only once the training is scheduled on your preferred days. Click on the button below to pre-register

Risk based approach to GxP Compliant Laboratory Computerized Systems

CAROLYN TROIANO

PRE-REGISTRATION AVAILABLE If you want to have this training scheduled Live and Exclusively for your company, we will arrange it for you. Pre-Register now and pay only once the training is scheduled on your preferred days. Click on the button below to pre-register

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

CAROLYN TROIANO

Duration: 75 Minutes

How to go Paperless in an FDA-Regulated Environment using Electronic Workflow Signature Approvals and Electronic Records

CAROLYN TROIANO

Duration: 75 Minutes

3-Hour Virtual Seminar on GAMP® 5 Second Edition – The changes and its impacts that you should know

CAROLYN TROIANO

Duration: 3 Hours

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

CAROLYN TROIANO

Duration: 90 Minutes

Auditing Computer Systems for Part 11 and International Compliance

CAROLYN TROIANO

Duration: 90 Minutes

Computer System Validation For Cloud and Cots Applications

CAROLYN TROIANO

Duration: 6 Hours Completed | Recording and Pre-Registration Available

3 Hours Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries

CAROLYN TROIANO

Duration: 3 Hour

A RISK BASED APPROACH TO IT INFRASTRUCTURE QUALIFICATION, COMPLIANCE & CONTROL

CAROLYN TROIANO

Duration: 3 Hour

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

CAROLYN TROIANO

2-Day Seminar Completed | Recording and Pre-Registration Available

FDA’S RECENT REGULATION ON THE USE OF SOCIAL MEDIA

CAROLYN TROIANO

Duration: 90 Minutes

Computer Systems Validation (CSV)

CAROLYN TROIANO

Duration: 3 Days

4-Hour Virtual Seminar on Computer System Validation (CSV) and Data Integrity for Clinical Trials Regulated by FDA

CAROLYN TROIANO

Duration: 4 Hour

4-Hour Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries

CAROLYN TROIANO

Duration: 4 Hour

Data Governance for Computer Systems Regulated by FDA

CAROLYN TROIANO

Duration: 60 Minutes

Master the Vendor Auditing of your Computer Systems Regulated by FDA - Copy

CAROLYN TROIANO

Duration: 90 Minutes

3-Hour Virtual Seminar on Computer System Validation (CSV) vs Computer Software Assurance (CSA) – Following a Waterfall vs Agile Methodology

CAROLYN TROIANO

Duration: 3 Hour

Tobacco Industry Trends for Computer Systems Regulated by FDA

CAROLYN TROIANO

Duration: 75 Minutes

FDA Compliance and GAMP V Computer System Classification

CAROLYN TROIANO

Duration: 75 Minutes

Pharmaceutical Trends for Computer Systems Regulated by FDA

CAROLYN TROIANO

Duration: 75 Minutes

FDA Compliance and Laboratory Computer System Validation

CAROLYN TROIANO

Duration: 90 Minutes

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

CAROLYN TROIANO

Duration: 75 Minutes

Medical Device Software 62304 Compliance

CAROLYN TROIANO

Duration: 90 Minutes

Project Management Best Practices for Computer Systems Regulated by FDA

CAROLYN TROIANO

Duration: 75 Minutes

Most Common Challenges in FDA Software Validation and Verification, Computer System Validation and Overcoming them: Step-by-Step

CAROLYN TROIANO

Duration: 60 Minutes

System Development Life Cycle (SDLC) Methodology and FDA-Regulated Systems

CAROLYN TROIANO

Duration: 60 Minutes

FDA Computer System Audit – Best Preparation Practices

CAROLYN TROIANO

Duration: 60 Minutes

Organizational Change Management for FDA Regulated Computer Systems

CAROLYN TROIANO

Duration: 60 Minutes

Latest FDA and EMA Global Labeling Challenges and Requirements

CAROLYN TROIANO

Duration: 60 Minutes

In Depth Testing of Computer Systems Regulated by FDA

CAROLYN TROIANO

Duration: 60 Minutes

3-Hour Virtual Seminar on Best Practices to Help you Pass an FDA Computer System Validation Audit

CAROLYN TROIANO

Duration: 3 Hour

Applying Computer System Validation to Mobile Applications

CAROLYN TROIANO

Duration: 60 Minutes

3-Hours Virtual Seminar – Medical Device Cybersecurity and FDA Compliance

CAROLYN TROIANO

Duration: 3 Hour

Good Documentation Practices to Support Computer System Validation

CAROLYN TROIANO

Duration: 60 Minutes

How to Apply for a Breakthrough Therapy Designation and Win It

CAROLYN TROIANO

Duration: 60 Minutes

CSV Boot Camp - 3-Day Certification Course

CAROLYN TROIANO

3-Day Seminar Completed | Recording and Pre-Registration Available

Data Integrity by Design and Pharma 4.0: Next-Gen Techniques to Approach GxP Systems, and FDA Compliance

CAROLYN TROIANO

2-Day Seminar Completed | Recording and Pre-Registration Available

Clinical Trial Master File (TMF) And Electronic Trial Master File (ETMF)

CAROLYN TROIANO

Duration: 90 Minutes

21 CFR Part 11 Data Integrity Training for CSV, CSA, SaaS/Cloud - How to Reduce Costs for Compliance

CAROLYN TROIANO

PRE-REGISTRATION AVAILABLE If you want to have this training scheduled Live and Exclusively for your company, we will arrange it for you. Pre-Register now and pay only once the training is scheduled on your preferred days. Click on the button below to pre-register

Using Audit Trails To Support Part 11 Data Integrity Compliance

CAROLYN TROIANO

Duration: 90 Minutes

Risk-Based Excel Spreadsheet Validation

CAROLYN TROIANO

Duration: 90 Minutes

3-Hour Virtual Seminar On Digital Validation Demystified - GAMP® 5 2.0 And CSA Integration

CAROLYN TROIANO

Duration: 3 Hour

Cybersecurity in Medical Devices Latest Guidance: Quality System Considerations and Content of Premarket Submissions

CAROLYN TROIANO

Duration: 90 Minutes

CSV vs CSA - Waterfall vs. Agile Methodology, Documentation and Implementation

CAROLYN TROIANO

September 23 -24, 2024 | US Eastern Time: 10 AM to 3 PM | Central Europe Time: 4 PM to 9 PM

SaMD Masterclass - Validation, Change Management, Cybertechnology, and Best Practices

CAROLYN TROIANO

October 21 - 22, 2024 | US Eastern Time: 10 AM to 3 PM | Central Europe Time: 4 PM to 9 PM

Validating and Auditing Cloud, SaaS, IaaS, PaaS Systems - Tech & Validation Trends for FDA Compliance

CAROLYN TROIANO

December 16 - 17, 2024 | US Eastern Time: 10 AM to 3 PM | Central Europe Time: 4 PM to 9 PM