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Rachelle D Souza

Rachelle D’Souza began her career in regulatory compliance in 2007. She has provided Regulatory Affairs, Quality Assurance, Clinical, Pharmacovigilance and Medical Information support to the Pharmaceutical, Biologic, Generic, Natural Health Product, Dietary Supplement, Medical Device, Cosmetic, Pesticide and Food industries.

Rachelle has developed regulatory strategies, independently prepared regulatory submissions and secured product and site approvals from global regulatory agencies. She has also designed, implemented, and maintained global quality, pharmacovigilance and medical information systems. Rachelle’s regulatory articles and webinars on the latest global

regulatory developments have been published in print and online by regulatory professional associations, webinar hosting platforms and industry magazines.


Live Webinars

Chronicles

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By: Rachelle D Souza

Recorded Session

FDA Recommendations for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions

AI is expected to change healthcare, but it brings risks around ethical data use, biased algorithms, patient safety and cybersecurity. FDA has started overseeing AI/ML-enabled device software func…

Industry: FDA Compliance   Duration: 75 Minutes