Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar
Join us for a webinar on June 25 for a discussion of the webinar
In 1983, 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 industry has been validating systems for several decades, recent findings by FDA during 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:
- Business criticality
- GAMP 5 category (e.g., COTS, configurable code, custom code)
- Risk Assessment (if the system should fail)
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.
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:
- Quality Culture
- Batch Records
- Manufacturing Floor
- Raw vs. Recorded Data
- Lab Equipment
- Analytical Documentation
- Document Control
- Lab Control Procedures
- Materials Management
Why Should You Attend
- Understand the guidelines clarifying FDA’s position on data integrity, including how they should be interpreted and applied, and how FDA is currently enforcing them
- Understand in detail the application of FDA’s guidelines for Computer System Validation (CSV), based on the System Development Life Cycle (SDLC) methodology
- Learn how to apply GAMP 5 system categorization and system risk assessment concepts to validation of computer systems regulated by FDA
- Learn the best practices for maintaining a computer system in a validated state throughout its entire life cycle, including all data (structured and unstructured) housed and/or managed using the system
- Learn about current trends in FDA compliance and enforcement as they relate to data integrity issues and citations
- Learn about industry best practices that will lead to inspection readiness
- Learn about the roles of data/system owners vs. data/system stewards, and the training, documentation and policies/procedures that will support their efforts
This webinar will cover the following key areas:
- Define the meaning of data integrity and focusing on the criteria necessary for FDA compliance
- Provide an overview of recent FDA compliance and enforcement trends that focus on data integrity issues identified during audit and inspection
- Learn about the top ten areas where companies have failed to achieve data integrity compliance and why
- Learn how to establish a data governance framework and program for data that is collected, analyzed, stored or reported using a computer system subject to FDA regulations
- Learn how to ensure that data governed by FDA adheres to the principles of Computer System Validation (CSV), System Development Life Cycle (SDLC) Methodology, and Electronic Records and Signatures (21 CFR Part 11), as applicable
- Find out how your company can leverage industry best practices in developing an overall data governance framework and program
- Understand how to ensure your data integrity is met and maintained through its life cycle
Can't Make this LIVE Webinar?
Simply select the Recorded option when registering and we will send you the link to view the recorded version.
Who will Benefit
Anyone who is involved in the development, testing, manufacturing, storage, handling and distribution of product must understand and conform to FDA requirements for data quality and integrity.
Finally, anyone who is acting as a consultant or contractor to a company in an FDA-regulated industry should attend to ensure they are able to bring the most current knowledge and expertise to their assignment.
Industries who can attend
This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.
Faculty Carolyn Troiano
Carolyn Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs