Carolyn Troiano

ERP Project Manager, City of Richmond

Training Overview

The attendee will learn how to comply with FDA's 21 CFR Part 11 guidance, which addresses the use of electronic records and electronic signatures (ER/ES). There are specific security and authentication requirements that are not necessarily covered by the standard computer system validation (CSV) approach, and go somewhat beyond this.

We will also address the roles of people involved in validating and supporting the systems, aside from just the standard system users. There are many tasks and functions they need to understand in order to be in compliance.

Agenda

Part I The Keys to COTS Computer System Validation 1 hour

  • The Keys to COTS Computer System Validation
  • “GxP” Computer Systems
  • Regulatory Oversight
  • Software Categorization
  • “COTS” Software
  • “Cloud” Solutions
  • SaaS Solutions

Part II Step-Wise Process for COTS Risk-Based Computer System Validation and Change Control 1 hour

  • Computer System Validation (CSV)
  • System Development Life Cycle (SDLC) Methodology
  • Computer System Risk Assessment
  • CSV Policies and Procedures
  • System Operations and Maintenance
  • Organizational Readiness
  • CSV Documentation
  • System and Data Governance

Break 30 min

Part III 21 CFR Part 11 Compliance 1 hour.

  • FDA’s 21 CFR Part 11 Electronic Records and Electronic Signatures (ER/ES) Compliance
  • 21 CFR Part 11 Overview
  • 21 CFR Part 11 Compliance
  • Part IV Purchasing COTS Software 1 hour
  • Vendor Audit Background
  • Vendor Audit Strategy and Planning
  • Vendor Audit Execution
  • Validation Strategy
  • Validation Components

Part V Industry Best Practices 1 hour

  • FDA Inspection Trends
  • Industry Trends - Deficiencies
  • Industry Best Practices
  • Wrap-Up Session
  • Q&A 30 mins

Who will benefit

Professionals in the following industries may also benefit from the content:

  • Pharmaceutical
  • Medical Diagnostics
  • Biotechnology
  • Tobacco and Related (Vapor, e-Cigarette, Cigar, etc.)
  • Animal Health
  • Any other FDA-regulated industry, plus any Life Science Consulting or Contracting firm
  • Information technology managers and analysts
  • Production managers and analysts
  • QC/QA managers and analysts
  • Clinical data managers and scientists
  • Compliance managers
  • Lab managers and staff
  • Automation analysts
  • Computer system validation specialists
  • GMP training specialists
  • Business stakeholders and individuals who are responsible for computer system validation planning, execution, reporting, compliance, training and audit
  • Consultants working in the life sciences, tobacco and related industries who are involved in computer system implementation, validation and compliance


Faculty Carolyn Troiano

Carolyn Troiano

Midlothian, Virginia, United States

Award winning FDA Compliance Speaker for Validation, 21 CFR Part 11 (Electronic Records/Signatures) and Data Integrity

My experience includes 34+ years in IT/ Business, Marketing & Compliance leadership and management roles at a variety of Fortune 100 companies, across multiple industries.

My successes include building and managing teams and business units at multiple “greenfield” sites in the pharmaceutical, biotechnology and IT consulting industries, as well as in the public sector. I have weathered numerous layoffs, mergers and acquisitions, and demonstrated my very strong leadership skills in helping staff get through difficult times.

Choose a Purchase Options


$299

Live Webinar - Single Partcipant

You get one log-in for the live 180-minute webinar for one participant, presentation materials and the opportunity to ask questions by phone and email

$489

Group Up to 5 Participants

You get 5 log-in for the live 180-minute webinar for all the participant, presentation materials and the opportunity to ask questions by phone and email

$389

Recorded Access Corporate Group

You'll have 12 month access to one log-in for an archived recording of the entire 180-minute webinar, including the Q&A period. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

$899

Purchase Using Webinar All-Access Pass

(One user get unlimited access to all upcoming and recorded webinars (350+) for one year)

Our Participants Testimonial


The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterward about it. ( FDA Compliance and Mobile Applications Webinar )

Robert Friedland ( IT Manager) NUTEK BRAVO, LLC.

Thank you for providing the information in such detail. It was helpful to gain the perspective of somebody that has implemented these regulations in a working lab. Virtual Seminar on ( Training on Life cycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines )

Tracey Kessler ( Director of R&D) CEL-SCI Corporation

I felt the seminar was very helpful and provided good insight for DataIntegrity and what the FDA is looking for per the regulations. ( Current Regulatory Thinking on Data Integrity 2 Days Virtual Seminar )

Margaret A. Clifton ( Manager, Quality Systems) CSL Plasma

The presenters subject matter knowledge is extensive which enables information to be shared in detail. (Training Attended on Risk Based Verification and Validation Planning to Meed US FDA and ISO 13485 Requirements )

Stuart Chisholm (Sr. Principal Device Engineer) Teva Pharmaceuticals

About World Compliance Seminars (WCS)

World Compliance Seminars (WCS) is one stop solution for all your pharmaceuticalbiotechnology and medical device certification program needs. The pharmaceutical and medical device training requirements are set forth by the FDA (Food and Drug Administration) and other major regulatory bodies like NIHEMA, as well as numerous European based national regulatory bodies.

These requirements are important to the training of pharmaceutical reps who are responsible for the education, professional development, and on-the-job training. The training is broken down into different sections to cover a wide variety of topics, including pharmaceutical formulation, pharmaceutical transfer processes , GLP, GMP, Clinical ComplianceProcess Validation, Global Regulatory Affairs, Document Management,GMP (Good manufacturing practice) QSR and CMC and many more.

The pharmaceutical and medical device requirements that the FDA has set forth are designed to protect the public's health and safety. Pharmaceutical reps must adhere to all of the regulations and education courses provided by the FDA in order to be considered one of the best in their field. They also must complete ongoing educational opportunities and maintenance programs in order to maintain relevance and career enhancement.

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