Good Documentation Practices to Support FDA Computer System Validation

OVERVIEW

FDA requires that all documentation related to GxP products (GMP, GLC, GCP) 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.

The 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 guidelines, deliverables and how to document them.

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 computer system validation guidelines and the many deliverable documents that need to be produced in a way that meets FDA compliance standards. 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 guidelines
• System Development Life Cycle (SDLC) methodologies
• Validation deliverables
• Risk assessment methodology
• GAMPV system categorization
• Industry best practices
• Potential pitfalls

LEARNING OBJECTIVES

• To understand how to create, revise and maintain documentation that is FDA-regulated
• To understand the computer system validation guidelines and many deliverables required to complete it
• 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
• 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

Years of Experience: 35+ years

Areas of Expertise: Strategic Planning, Project Management, FDA Regulatory Compliance, Organizational Development & Effectiveness, and Change Leadership & Management

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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