Published: April, 2022
Has your firm been issued one or more Form 483s by FDA?
Are you concerned about writing a successful response?
This CPE webinar will provide you with the best practices for writing a solid response that will be well-received by FDA and limit the company’s exposure to further regulatory action, such as a Warning Letter.
FDA has substantial authority to oversee regulated companies and their operations. The primary purpose of the FDA is to assure safe and effective products that will protect public health. Violations can have seriously adverse effects on products, and ultimately, on patients and consumers.
The root of every company’s efforts to defend their practices and products is through data and documentation, meaning both structured data (database) and unstructured data (documents, spreadsheets, presentations, audio, video, etc.). Computer systems used to house, collect, modify, analyze, report, transfer, or otherwise manage both structured and unstructured data must be validated in accordance with FDA requirements to assure data integrity. By not doing so, a company leaves itself exposed to FDA scrutiny and the possibility of a Form 483 citation, or even more severe consequences.
Since 1953, FDA has been provided with the authority to conduct formal inspections of regulated companies, both announced and unannounced. During the inspection, an FDA auditor may have observed specific practices and/or review specific data/documentation that is out of compliance with regulations.
In this CPE webinar, we will provide the most frequently cited issues to enable your company to get ahead of the curve and avoid a similar fate.
Based on the observed findings, the auditor may provide a Form 483 citation, indicating the company has 15 days to respond if the response is to be considered when determining whether further action is needed.
If the response is not adequate, this may lead to further enforcement action, which can be very costly and time-consuming. We will guide avoiding such a situation, or at least minimizing it. Writing an effective response that will minimize the possibility of further action by the FDA is a challenging task, and should be done very carefully.
In this CPE information technology webinar, we’ll focus on the specific best practices required to assure an adequate response. We will also review examples of good and bad responses to gain more insight and direction for creating one.
Finally, we will provide an overview and the key components of a good CAPA program. The CAPA is at the heart of a company’s response to FDA’s findings and must be done appropriately.
MY-CPE LLC, 1600 Highway 6 south, suite 250, sugar land, TX, 77478
MY-CPE LLC (Sponsor Id#: 143597) is registered with the National Association of State Boards of Accountancy (NASBA) as a sponsor of continuing professional education on the National Registry of CPE Sponsors. State boards of accountancy have final authority on the acceptance of individual courses for CPE credit. Complaints regarding registered sponsors may be submitted to the National Registry of CPE Sponsors through its website: www.NASBARegistry.org.
Account Executive, BrainStorm Central Consulting LLC
Carolyn Troiano has more than 35 years of experience in computer system validation and compliance in the pharmaceutical, medical device, 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.
BrainStorm Central Consulting is the leader and premier catalyst for moving companies to a new level by outstripping conventional wisdom and thought, and creating a strategy that goes beyond the realm of “better, faster, cheaper”.
"Our experience will lead you to us, your experience will keep you coming back..."
FDA Compliance Training Topics Offered:
• Developing a Strategic Approach to FDA Compliance for Computer Systems
• FDA’s Deeming Regulations for e-Cigarettes, Cigars, and other Tobacco-related Products
• Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance
• Medical Device Industry Trends for Computer Systems Regulated by FDA
• Tobacco and Related Industry Trends for Computer Systems Regulated by FDA
• FDA Deeming Rule for Tobacco Related Products and Recent Actions: eCigarettes, eLiquids, Cigars
• FDA Compliance and Mobile Applications
• Good Documentation Practices to Support FDA Computer System Validation
• In-Depth Computer System Testing of Computer Systems Regulated by FDA
• Disaster Recovery and Business Continuity Planning for Computer Systems Regulated by FDA
• Data Integrity and Governance for Computer Systems Regulated by FDA
• Trends in FDA Compliance and Enforcement for Regulated Systems
• Best Practices in Preparation for an FDA Computer System Audit
• Functional System Requirements for Computer Systems Regulated by FDA
• Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA
• 21 CFR Part 11 (e-Records/Signatures) Compliance for Computer Systems Regulated by FDA
• C-TPAT Compliance for FDA-Regulated Industries
• Medical Device Cybersecurity and FDA Compliance
• 21st Century Cures Act and Medical Device Software Compliance
• Medical Device Software 62304 Compliance
• Creating, Reviewing & Managing Audit Trails: Compliance for FDA-Regulated Computer Systems
• Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA