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Rachelle D Souza

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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 Webinar

Recorded Session

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By: Rachelle D Souza

Recorded Session

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

AI or Artificial Intelligence is thought to revolutionize many industries including healthcare. There are however many risks of AI in the health care sector. These include concerns such as the eth…

Industry: FDA Compliance   Duration: 75 Minutes