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

21 CFR Part 11 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

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