Is your manufacturing and lab data reliable?
Are you sure that it will pass muster with regulators?
Virtually every area of your operations depends on the integrity of your data. Validating an FDA-regulated system and maintaining it in a validated state will provide strong assurance that the data created, analyzed, processed, transferred or managed using the system will have integrity, which will be maintained throughout its life cycle. This includes structured data, such as found in database records, and unstructured data, such as documents, spreadsheets, slides, images, audio, video, and other types.
In recent years, FDA inspections and audits have uncovered many data integrity problems, which have been the subject of Form 483 citations and Warning Letters. In fact, the incidence of Warning Letters related to data integrity issues has risen sharply in the past ten years. Most of these are “unforced” errors, most often due to companies doing more work with fewer resources. The constraints on manpower have resulted in errors and mistakes that could easily be avoided.
If you want to lock down your systems to make sure data integrity issues will not creep in, you need to identify the most common, and often most critical gaps that can lead to serious data integrity problems.
The Top Ten Data Integrity Traps webinar will help you to understand where most data integrity problems occur and to create a plan of action enabling you to proactively detect, prevent and mitigate them. You’ll learn about 10 key areas to focus on to minimize, if not avoid, data integrity violations:
In 1983, the FDA provided guidelines for validating regulated computerized systems, and very little has changed since that time, other than technology. The premise for compliance is demonstrating clearly and completely that a computer system does what it purports to do. This means developing a very detailed set of unique and testable functional requirements and creating a set of test scripts that will prove each requirement is met.
While the industry has been validating systems for several decades, recent findings by the FDA during the inspection of computerized and automated operations indicate that data integrity issues have been increasing sharply and continue to do so. FDA issued a guidance document in 2018 to clarify their thinking on data integrity and compliance.
This webinar will describe the approach to validation based on several key factors:
The level and robustness of testing required will take into account all of these factors, as well as the value of the data that will be housed and/or processed using the system. The rationale for type and level of testing is documented in the Validation Plan.
In addition to a strong validation program, a company must have specific policies and procedures in place to support each system through its entire life cycle. Training and Organizational Change Management (OCM) will also be discussed, as key elements for supporting systems and data.
Why should you attend?
Areas Covered in the Session :
Who will benefit:
All FDA-regulated industries:
Anyone who is involved in the development, testing, manufacturing, storage, handling and distribution of products must understand and conform to FDA requirements for data quality and integrity.
Finally, anyone who is developing and maintaining software used in these industries should be aware of the requirements for data integrity for their systems.
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Recorded video session
Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects. During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA's electronic record/electronic signature regulation. Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI's Educational Fund as a project management instructor for non-profit organizations.