FDA Compliance and Enforcement Trends focused on Data Integrity - Webinar (Recorded)

Why Should You Attend:

Effective and compliant computer system validation is critical to any FDA-regulated organization. FDA has set forth very specific requirements for meeting compliance, and a very prescriptive set of enforcement actions to protect patient and/or consumer safety. This course will enable you to best anticipate and prepare for FDA scrutiny, understand your role during inspections and audits, and gain insight to the level of enforcement associated with various findings, consent decrees and warning letters. Examples from industry will be used as case studies to illustrate these.

It is vital for regulated companies to maintain a pulse on the regulatory environment in order to fortify system validation efforts, as necessary, to meet FDA expectations. It is the best practice to have a robust computer system validation, continue executing against it consistently, and documenting it thoroughly. By maintaining a strong and consistent computer system validation program, companies can further build trust with FDA and the consumers who rely on such oversight for protection.

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.

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.

Since 1983, with the issuance of the guidance document from FDA on validation of computerized systems, this topic has applied to pharmaceutical products and the computer systems used to generate, collect, analyze, process and report data. Subsequently, the FDA applied the same guidance to computer systems used in the biologics and medical device industries.

More recently, the FDA has brought tobacco products under their regulatory jurisdiction, and has applied guidelines for validation of computer systems used in the manufacture, testing or tracking of tobacco-related products. This includes cigarettes, cigars, e-cigarettes and other forms of smokeless tobacco, such as “pouch” products.

There are specific requirements for the execution and documentation of the computer system validation process, particularly the requirements and testing components. It is crucial that you build a solid program that can be defended during an FDA audit or inspection. There are also policies needed to support these efforts.

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.

This session will provide some insight into current trends in compliance and enforcement. Some are based on technology changes, and these will continue to have an impact as new innovations come into use in the industry.