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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.
This is an On-demand recording from March 2022.
This event is brought to you by:
Regulatory affairs professionals become more keenly aware of industry trends through eCTD issue resolution.
In this virtual program, regulatory operations specialist Joshua Lett will examine several commonly seen eCTD submission challenges and discuss their resolutions. The presentation will explore the future of eCTD submissions and the practical applications of eCTD issue resolution in order to more proactively anticipate shifts in the industry.
The agenda may vary based on changing requirements.
Regulatory Operations Specialist II, Certara
Keri Wittekind is an experienced submission publisher, having supported numerous applications including NDAs, ANDAs, INDs, and maintenance submissions. For many of these, she was the point of contact for the regulatory affairs teams to ensure that all regulatory standards and requirements as well as the submission deadlines were met. Ms. Wittekind has an eye for detail from a previous position as an analytical data reviewer. She takes a proactive approach and prides herself on making personal connections to ensure smooth communication across a variety of teams and coworkers.
Senior Regulatory Operations Specialist, Certara
Carrie Ngangnang is a Senior Regulatory Operations Specialist with several years experience in regulatory operations electronic publishing, serving as project lead on multiple applications types and over 20 years serving in leadership roles, managing people and projects ranging from few to 300+.
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