FDA Compliance for GxP Regulated Computer Medical Device Systems & Current Trends

Overview of FDA computer system validation requirements, including 21 CFR Part 11 compliance

FDA requires that all computer systems that handle data regulated by the Agency to be validated in accordance with their guidance on computerized systems. This guidance was first issued in 1983, and the main points of focus remain consistent today, despite the number of years that have passed and the technology changes that have taken place.

The guidance was revisited for its application to the medical device industry, as the first issuance addressed pharmaceuticals. In 1997, 21 CFR Part 11 was issued to address electronic records and signatures, as many laboratories and other FDA-regulated organizations began seeking ways to move into a paperless environment. This guidance has been modified over the years to make it more palatable to industry, and this includes discretionary enforcement measures. The intent was to avoid creating a huge regulatory compliance cost to industry that was initially preventing companies from embracing the technology.

In this webinar expert speaker Carolyn Troiano will provide some insight into current trends in compliance and enforcement and cover the key aspects of complying with FDA requirements in both validating systems and maintaining them in a validated state throughout their entire life cycle.

Session Highlights:

Provide an overview of FDA computer system validation requirements, including 21 CFR Part 11 compliance.

Provide an overview of recent trends in FDA compliance and enforcement relative to computer system validation, including citations.

Provide a set of best practices and industry standards to meet FDA compliance requirements for computer system validation.

Why You Should Attend:

This webinar will focus on the key areas that are most important, including security and data integrity. Implementing and following the System Development Life Cycle (SDLC) methodology is the best approach for computer system validation and maintaining data integrity. The life cycle approach takes all aspects of validation into account throughout the life of the system and the data that it houses. The data is a key asset for any FDA-regulated company and must be protected through its entire retention period.

Who Should Attend:

Pharmaceutical

Medical Device

Information Technology Analysts

QC/QA Managers

QC/QA Analysts

Clinical Data Managers/Scientists

Compliance Managers

Laboratory Managers

Manufacturing Managers/Supervisor

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

Ask your question directly from our expert during the Q&A session following the live event.

Visit At Trends in FDA Compliance for GxP Regulated Computer Systems wabinar