6-Hour Webinar 21 CFR Part 11 (Electronic Records/Electronic Signatures) Compliance for Computer Systems Regulated by FDA.

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Why should you attend

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 has more than 35 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.

During her career, Carolyn collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.

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