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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.
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.
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.
Duration
Course Level
Instructional Method
Pre-requisites
Advance Preparation
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.
1.5 Credits
Add to WatchlistThis course is set to be rescheduled shortly. Please fill out the short form below, and we'll let you know as soon as the course becomes available
1. How can I earn Continuing Education credits for live webinars?
A: To earn credits, you must register for the webcast before it begins. Attend the entire live webinar and respond to polling questions if supported.
2. When will I receive my Continuing Education Credit Certificate?
A: You'll receive your certificate within 24 hours after each webinar.
3. What's the basis for credit issuance?
A: Credits are issued on a 50-minute credit hour basis.
4. What if I can't use the polling feature on a web browser?
A: The polling feature is only supported on the Zoom desktop and mobile app. You can provide responses in the chat if needed.
5. Are these live events or recordings?
A: Some events may be recorded, but instructors will be available for questions during/after the webinar.
6. Do myCPE courses meet professional standards?
A: Yes, myCPE meets global Continuing Professional Development (CPD-IES7) standards for various accounting and financial professions. Confirm with your licensing organization if needed.
7. Where can I manage my certificates and credits?
A: You can manage them through your certificate dashboard when logged into your account.
8. Is myCPE accredited for Continuing Professional Education in the United States?
A: Yes, myCPE is accredited by various professional organizations, making it suitable for fulfilling continuing education requirements.
9. Who can take myCPE courses?
A: myCPE courses are suitable for professionals with 100+ designations, including CPAs, CMAs, CFAs, and more.
10. What's the refund and complaint resolution policy?
A: To learn about the refund and complaint resolution policy, click here for details.
CPE
General
CPD
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