A Barnett Interactive Web Seminar offers you a seamless, secure, multimedia learning experience. These live, instructor-led sessions are designed to be highly interactive, and can be attended by individual attendees or groups at one low cost. No travel, no travel expenses, and no time away from the office!
Warning Letters: Applying Lessons Learned from Misbranding and Adulteration Noncompliance Findings
Upcoming Courses
In this web seminar, we will focus on common themes such as misbranding and adulteration found in warning letters issued by the FDA to pharmaceutical, medical device, and biotechnology companies. Specifically we will review the concepts of misbranding and adulteration in detail, and provide examples of where compliance issues commonly arise in these areas. We will discuss best practices for responding to warning letters, as well as strategies that can be implemented to help avoid them. Whether you are new to the warning letter experience or you are working on issues in response to one, you will find this web seminar useful.
- Describe examples of misbranding that have been cited by the FDA
- Describe examples of adulteration that have been cited by the FDA
- Describe best practice approaches to warning letter response
- Implement strategies to help avoid future actions by the FDA
- Regulatory Affairs Professionals
- Quality Assurance Personnel
- Research and Development Personnel
- Engineering Professionals
- Manufacturing Personnel
- Clinical Development Personnel
Joy Frestedt, Ph.D., C.P.I., R.A.C., F.R.A.P.S.
Click here for complete trainer biographies
$695
Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.
For individual participants, this web seminar qualifies for a reduced individual participant fee of $349. To register, call +1 781.972.5400 or toll-free in the U.S. 800.856.2556.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-14-081-L01-P. Released: 10/14.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.
