The FDA has set out requirements for validating all computer systems that handle data regulated by it. These should be in accordance with its guidance on computerized systems, first issued in 1983. The main points of this guidance continue to be consistent today, even with all the changes that technological developments have brought in.
The 1990’s was a decade in which this guidance was revisited for its relevance to the medical device industry. This was because the first issuance was limited to pharmaceuticals. In 1997, in the context of the move of many FDA-regulated organizations to move into a paperless environment, the FDA issued 21 CFR Part 11, which sought to address electronic records and signatures.
A few changes, such as discretionary enforcement measures, have been brought into this guidance from then, to fashion it to the needs of the industry. Yet, this issuance is rather confusing, although it was intended to help the industry avoid creating a huge regulatory compliance cost, which was the main reason for which many companies were reluctant to adapt the technology.
What are the current trends in compliance and FDA enforcement? Technology is a major basis for these trends, although there are other that are based on economics, social media, new diseases, politics, and many other influences.
All these will be discussed in detail at a six-hour learning session from GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory compliance. Carolyn Troiano, a senior compliance professional who has worked in the tobacco, pharmaceutical, medical device and other FDA-regulated industries, will be the expert at this webinar, which is being organized on October 28.
Please visit https://www.globalcompliancepanel.com/virtual-seminar/6-hour-virtual-seminar-on-fda-trends-for-computer-system-validation-(csv)-compliance-and-enforcement-10310LIVE to enroll for this valuable learning.
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Everything that is required to protect the validity of data that is regulated by the FDA and is stored in electronic format in computer systems will be explained at this webinar. The expert will describe the ways by which to properly validate an FDA-regulated computer system so that security is ensured and data integrity objectives are met.
It is accepted that implementation and adaptation of the System Development Life Cycle (SDLC) methodology is the ideal approach for Computer System Validation (CSV) and for maintaining the system in a validated state throughout its life. Carolyn will explain this aspect in detail at this webinar.
She will also discuss the key areas that are most important during inspection and audit, including security, data integrity, validation, training, and documentation.
The following areas will be explained at this webinar:
Session 1 (90 Mins):
- FDA Regulatory Oversight
- Computer System Validation (CSV)
- System Development Life Cycle (SDLC) Methodology
Session 2 (90 Mins):
- GAMP 5 Software Categorization
- System Risk Assessment
Session 3 (90 Mins):
- Requirements
- Design
- Testing
- Requirements Traceability Matrix (RTM)
- Additional Validation Documentation
Session 4 (90 Mins):
- FDA Inspection Trends
- Regulatory Influences
- Response to Change
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About the speaker: During the over 35 years she has served in the tobacco, pharmaceutical, medical device and other FDA-regulated industries, Carolyn Troiano 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.
She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and also collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.
With over four million employed directly or in allied sectors and catering to the world’s largest market and research area, biotech and pharma is a fast growing industry. Its courses are designed to prepare individuals for this giant industry.
These three attributes form the backbone of the test of a medical device company’s successful compliance with the regulatory requirements. For a medical device company to be successful in applying ISO 14971:2012 and IEC 62304:2006; it has to implement a cross-standard and resourceful way of integrating activities covering these requirements documents.
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