In-Depth Testing of Computer Systems Regulated by FDA

    /Carolyn  /Troianospeaker of Training Doyens
    Speaker: Carolyn Troiano
    Date: Tuesday, November 28th
    Time: 01:00 PM EST | 10:00 AM PST
    Change TimeZone
    Duration: 90 Minutes
    Product Code: 50015
    Level: Intermediate
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OVERVIEW

This FDA compliance webinar will leave you with the information needed to create and maintain good documentation that meets FDA compliance standards.  You will learn about what must be done and what must not be done.  In addition, you’ll learn about the various computer system validation deliverables and how to document them through the entire process.

FDA requires that all documentation related to GxP (GMP, GLC, and GCP) products be created and maintained in accordance with specific rules.  From the color of the ink used to the retention requirements, you’ll learn all about how to create and maintain good FDA-compliant documentation.

WHY SHOULD YOU ATTEND

You should attend this webinar if you are responsible for any FDA-regulated data and/or records.  All documents need to be created and maintained in accordance with FDA guidelines for good documentation to avoid any issues during an inspection or audit.  You will also benefit from learning about the guidelines for computer system validation and the many deliverable documents that need to be produced in a way that is FDA-compliant.  Having completed this course, you will be on your way to successful future FDA audits and inspections.

AREAS COVERED

  • FDA Good Documentation Practices
  • Computer System Validation (CSV)
  • System Development Life Cycle (SDLC) Methodology
  • GAMPV System Categorization
  • Industry Best Practices
  • Potential Pitfalls
  • Q&A

LEARNING OBJECTIVES

  • To understand how to create, revise and maintain documentation that is FDA-regulated.
  • To understand the many deliverables required to complete a computer system validation effort.
  • To understand industry best practices.
  • To understand and avoid potential pitfalls.

WHO WILL BENEFIT

  • Information Technology Analysts
  • QC/QA Managers
  • QC/QA Analysts
  • Clinical Data Managers
  • Clinical Data Scientists
  • Analytical Chemists
  • Compliance Managers
  • Laboratory Managers
  • Automation Analysts
  • Manufacturing Managers
  • Manufacturing Supervisors
  • Supply Chain Specialists
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
  • Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
  • Auditors engaged in the internal inspection of labeling records and practices

All FDA-regulated industries:

  • Pharmaceutical
  • Biologicals
  • Medical Device
  • Tobacco

SPEAKER

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently managing a large, complex data migration, analytics and reporting program at a major financial institution.

During her career, Carolyn worked directly, or as a consultant, for many top-tier pharmaceutical companies in the US and Europe. She was responsible for computer system validation across all GxP functions at a major pharmaceutical company. Carolyn developed validation programs and strategies back in the mid-1980s, when FDA guidelines were first issued. She was an industry reviewer for 21 CFR Part 11, the FDA’s electronic record/electronic signature (ER/ES) regulation. She has taught ER/ES compliance, along with computer system validation and risk management/compliance at a number of Fortune 100 firms. Her experience includes work with FDA-regulated systems used in all areas of research, development, manufacturing, quality testing and distribution.

Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.

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Purchase Options

Live Session

for one participant

$199

Corporate Live Session

Group – Max 10 Participants from one location.

$549

Recorded Session

Get unlimited access to audio recording of the webinar for 6 months.

$219

Training CD

MP3 files, PDF presentation and reference manual will be delivered on a CD

$399

Super Combo Offer 1

Live and Recorded webinar

$329

Super Combo Offer 2

Live and Training CD

$499


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