Description

Learn the latest risk-based approach to Computer System Validation, 21 CFR Part 11 requirements based on current FDA compliance expectations

Course Description

FDA’s recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of importance for compliance of systems used in regulated industries. These include all systems that “touch” product, meaning they are used to create, collect, analyze, manage, transfer and report data regulated by FDA.

All structured data, including databases, and unstructured data, including documents, spreadsheets, presentations, images, audio and video files, amongst others, must be managed and maintained with integrity throughout their entire life cycle. It is a risk-based approach that leads to the best results and compliance with FDA’s expectations.

Electronic records and electronic signatures (ER/ES) came into play through guidelines established by FDA in 1997, and disseminated through 21 CFR Part 11. This code describes the basic requirements for validating and documenting ER/ES capability in systems used in an FDA-regulated environment.

In this webinar, we will explore the best practices and strategic approach for evaluating computer systems used in the conduct of FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety. We will walk through the System Development Life Cycle (SDLC) approach to validation, based on risk assessment, and will also discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately.

We will also walk through the entire set of essential policies and procedures, as well as other supporting documentation and activities that must be developed and followed to ensure compliance. This webinar will provide an overview of practices to prepare for an FDA inspection, and will also touch on the importance of auditing vendors of computer system hardware, software, tools and utilities, and services.

Finally, we will provide an overview of industry best practices, with a focus on data integrity and risk assessment that can be leveraged to assist in all your GxP work.

Why Should You Attend?

This session will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations. It is critical in order to develop the appropriate validation strategy.  Also to achieve the thoroughness required to prove that a system does what it purports to do, and a key element is a thorough risk assessment.

It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement, making it critical to continue assessing risk as changes are made. Additionally, we’ll discuss the phases within the SDLC, and how these form the basis for any CSV project. Also, the importance of the sequence of steps will be covered.

Course Objectives

This session will help attendees learn:

• How to identify “GxP” Systems
• Computer System Validation (CSV) approach based on FDA requirements
• System Development Life Cycle (SDLC) approach to validation
• Best practices for documenting computer system validation efforts, including requirements, design, development, testing and operational maintenance procedures
• Maintain a system in a validated state through the system’s entire life cycle
• Assure the integrity of data that supports GxP work
• Similarly, the importance of “GxP” documentation that complies with FDA requirements
• Policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state
• Discuss the key components of 21 CFR Part 11 compliance for electronic records and signatures
• Regulatory influences that lead to FDA’s current thinking at any given time
• Conduct a risk assessment on computer systems that will provide the basis for developing a validation rationale
• Need to include an assessment of a computer system’s size, complexity, business criticality, GAMP 5 category and risk, should it fail, to develop a cohesive and comprehensive validation rationale
• Assess risk, based on probability of occurrence, severity of impact, detectability and mitigation, along with technical and procedural controls that can help minimize risk
• To best prepare for an FDA inspection or audit of a GxP computer system
• Importance of performing a thorough vendor audit to ensure oversight to the products and services they deliver
• Finally, understand the industry best practices that will enable you to optimize your approach to validation and compliance. It’ll be based on risk assessment, to ensure data integrity is maintained throughout the entire data life cycle.

Who Will Benefit

This webinar is intended for professionals in the Medical Device, Biotechnology, Pharmaceutical Industry. Personnel in the following roles 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
  • Senior Leadership
  • Human Resource Directors, Managers & Representatives
  • Compensation Professionals
  • Operations Professionals
  • Managers & Supervisors
  • Employees

About the Instructor

Carolyn Troiano is a FDA Compliance Consultant for Validation, 21 CFR Part 11 (Electronic Records/Signatures) and Data Integrity.

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

Carolyn’s 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. She has weathered numerous layoffs, mergers and acquisitions, and demonstrated very strong leadership skills in helping staff get through difficult times.

Her role has often been that of a liaison between technical and business staff, translating business needs into people, process and technical solutions, and developing ROI and risk models used to support funding.

View other FDA webinars:

Data Integrity Compliance for Computer Systems Regulated by FDA