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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
In this webinar, experts from Med Safety Board, a subsidiary of the Institute for Safe Medication Practices, will review the significant changes that were incorporated into the finalized FDA guidance: Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors.
Understand and apply FDA guidance on safe medication container labeling to minimize product-use errors and risks.
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Regulatory, quality, operations, and product management professionals within life science organizations.
Rebecca (Becky) Lamis, PharmD, FISMP, is a Medication Safety Analyst at the Institute for Safe
Medication Practices. She also manages the Med Safety Board. Lamis began as a safe medication management fellow. She then assisted in developing and reviewing numerous ISMP medication safety tools, resources, and publications; analyzing medication error
reports and self-assessment data submitted by healthcare facilities; and participating in onsite risk
assessments. In her current role, she has led various packaging and labeling projects. Lamis also has experience utilizing failure mode and effects analysis
as a risk assessment method. During a residency at Wesley Medical Center in Wichita, she gained valuable clinical experience in optimizing medication
therapy and providing care to both adult and pediatric patients. She also conducted research and
received training in grantsmanship and medication safety.
Kristine Needleman has been a pharmacist since 1994 and has taken an active role in
medication safety from the beginning of her career. Needleman’s clinical experience spans retail pharmacy, community clinic settings, inpatient pharmacies, and operating-room pharmacies. She owns K Needleman Consulting, where she assists pharmaceutical companies in developing safe product labels and trademarks. She is interested in creating product packaging and labels with an eye toward error mitigation. Prior to opening her own shop, Needleman spent 17 years with ISMP. She is knowledgeable in
Failure Mode and Effects Analysis and has
been a team leader on several human factors testing projects. She earned an undergraduate degree in chemistry from Albion College and a BS in pharmacy from Ferris State University.
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.
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A certificate of attendance can be downloaded
from the RAPS Learning Portal
following the event.
For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshop: https://www.raps.org/website/virtual-event-helpFor account support, contact the RAPS Support Center: at +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email firstname.lastname@example.org.