Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA 1.5 Credits 1.5 Credits
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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 structure 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 citations, 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.Â
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 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.
| License details | Credits | Status |
|---|---|---|
| Information Technology for Certified Public Accountants (CPA-US) | 1.5 CPE | Approved |
| Certified Information Technology Professionals (CITP) | 1.5 CPD | Eligible |
| Certified Information Systems Auditor (CISA) | 1.5 CPE | Eligible |
| Certified Wealth Strategist (CWS) | 1.5 CE | Eligible |
| Certified Fiduciary and Investment Risk Specialist (CFIRS) | 1.5 CE | Eligible |
| License details | Credits | Status |
|---|---|---|
| Information Technology for Certified Public Accountants (CPA-US) | 1.5 CPE | Approved |
| Certified Information Technology Professionals (CITP) | 1.5 CPD | Eligible |
| Certified Information Systems Auditor (CISA) | 1.5 CPE | Eligible |
| Certified Wealth Strategist (CWS) | 1.5 CE | Eligible |
| Certified Fiduciary and Investment Risk Specialist (CFIRS) | 1.5 CE | Eligible |
Credits
1.5
Course Level
Basic
Instructional Method
QAS Self Study
Group Internet Based
Pre-requisites
None
Advance Preparation
None
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.
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.
What is Self Study (QAS)?
Self Study QAS (Quality Assurance Service) is a NASBA and other regulatory bodies approved program designed for Professionals to complete their Continuing Professional Education credits through self-paced, interactive courses that meet the highest standards of quality and compliance. We are approved by NASBA, IRS, CFP Board, HRCI, SHRM, Payroll Org, FP Canada, and 25+ other regulatory bodies.
How do I earn CPE credits through self-study?
To earn CPE credits, you must complete the self-study course, pass the required assessments, and submit the necessary documentation. Credits are awarded based on the completion of course hours and successfully passing the assessments.
Are the self-study courses approved by NASBA and other regulatory bodies?
Yes, all our self-study courses are approved by NASBA, IRS, CFP Board, HRCI, SHRM, Payroll Org, FP Canada, and 25+ other regulatory bodies, ensuring they meet the rigorous standards for quality and educational content set by these organizations.
What are the requirements to maintain compliance with self-study courses?
To maintain compliance, you must follow the guidelines set by NASBA and other regulatory bodies, which include completing the course within the specified timeframe, passing the assessments, and keeping accurate records of your learning activities.
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After successfully completing a self-study course and passing the assessments, you can access and download your course completion certificates from your account dashboard on our platform. These certificates are recognized by NASBA, IRS, CFP Board, HRCI, SHRM, Payroll Org, FP Canada, and 25+ other regulatory bodies for compliance and reporting purposes.
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We issue instant credit certificates, ensuring they are valid for presentation to governing bodies. Typically, we report IRS, CTEC, CFP, IDFP, IWI, VBOA Ethics credits within 7 days – the fastest in the industry.
What is a Live Webinar Group Internet-Based Credit?
A Live Webinar Group Internet-Based Credit is an interactive, real-time online seminar where professionals can earn Continuing Education credits by participating in live sessions led by experts in various fields. These sessions meet the standards set by NASBA, IRS, CFP Board, HRCI, SHRM, Payroll Org, FP Canada, and 25+ other regulatory bodies.
How do I earn credits through live webinars?
To earn credits, you must attend the entire live webinar, actively participate in any polls or questions, and complete any required evaluations or assessments. Credits are awarded based on your attendance and participation in the live session.
Are the live webinars approved by NASBA and other regulatory bodies?
Yes, all our live webinars are approved by NASBA, IRS, CFP Board, HRCI, SHRM, Payroll Org, FP Canada, and 25+ other regulatory bodies, ensuring they meet the high standards for quality, interactivity, and educational content set by these organizations.
What are the requirements to maintain compliance with live webinar courses?
To maintain compliance, you must adhere to the guidelines set by NASBA and other regulatory bodies, which include attending the full duration of the webinar, participating in interactive elements, and completing any post-webinar evaluations or assessments.
How can I access my webinar completion certificates?
After successfully attending a live webinar and fulfilling all participation requirements, you can access and download your completion certificates from your account dashboard on our platform. These certificates are recognized by NASBA, IRS, CFP Board, HRCI, SHRM, Payroll Org, FP Canada, and 25+ other regulatory bodies for compliance and reporting purposes.
How are credits reported to governing bodies?
We issue instant credit certificates, ensuring they are valid for presentation to governing bodies. Typically, we report IRS, CTEC, CFP, IDFP, IWI, VBOA Ethics credits within 7 days – the fastest in the industry.
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We issue instant credit certificates, ensuring they are valid for presentation to governing bodies. Typically, we report IRS, CTEC, CFP, IDFP, IWI, VBOA Ethics credits within 7 days - fastest in the industry.
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