Medical Device Industry Trends for Computer Systems Regulated by FDA

FDA requires that all computer systems used to produce, manage and report data for “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit.

Why Should You Attend

You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system. Also, if you are developing and supporting software that is used in conjunction with a medical device or is considered to be software as a medical device, you will benefit from this session.

As a “GxP” system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA’s CFR Part 11 guidance on ER/ES must be followed.

Many medical devices now incorporate software into the system as a component. In other cases, software as a medical device (SaaMD) are manufactured and marketed. In all cases, the validation of the software is critical to ensuring FDA compliance.

This webinar will focus on the key areas that are most important for protecting the validity of data that is regulated by FDA and is typically housed electronically in computer systems. This includes how to properly validate an FDA-regulated computer system in order to ensure security and data integrity objectives are met. Implementing and following the System Development Life Cycle (SDLC) methodology is the best approach for Computer System Validation (CSV) and maintaining the system in a validated state throughout its life.

The SDLC approach takes all aspects of validation into account throughout the life of the system and protects the data that it houses through its retention period. The data is a key asset for any FDA-regulated company and must be protected. If data becomes invalid, based on improperly validating and maintaining the system that houses it in a validated state, the work related to the data would need to be repeated. This could result in a devastating loss to any company’s bottom line.

We will also address software used as a component of medical devices and software as a medical device (SaaMD).

We will discuss the key areas that are most important during inspection and audit, including security, data integrity, validation, training, and documentation. The webinar will also address roles and responsibilities, timing of phases and deliverables, business process reengineering, organizational change management, change control and audit trails, training and documentation. 

You will learn what is required not only to validate your laboratory system, but maintain it in a validated state until it is retired or otherwise no longer in use.

There is an enormous body of documentation and information available on computer system validation, which can be overwhelming. This course will provide a condensed overview of the practices that deliver the best results by directing the attendees to the most critical and cost-effective of methods, techniques and tools available.

Areas Covered in the Webinar

Who Will Benefit

This webinar is intended for those involved in planning, execution and support of computer system validation activities, working in the FDA-regulated industries, including pharmaceutical, medical device, biologics, tobacco and tobacco-related products (e-liquids, e-cigarettes, pouch tobacco, cigars, etc.). Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, sample labeling, adverse events management and post-marketing surveillance.

Examples of who will benefit from this webinar include:

Manufacturing, Testing, Packaging and Distribution companies in the following industries that are regulated by FDA are required to follow GxPs: