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Emerging FDA Trends in Computer System Validation (CSV)

Emerging FDA Trends in Computer System Validation (CSV)

The life science industries, including pharmaceutical, medical device, biotechnology, biological, tobacco and tobacco-related products continue to embrace new technology to improve delivery of quality products in compliance with FDA.
We have seen the recent trend in industry toward using cloud-based services, Software-as-a-Service (SaaS) solutions, and other technical innovations. More recently, we have begun to see newer, emerging technologies including Artificial Intelligence (AI), Machine Learning (ML) algorithms & Large Language Models (LLMs), such as ChatGPT begin to find a presence within these companies.
While life science companies tend to lag behind other markets in using these technologies, they are catching up and we are seeing much greater use of AI in the development, testing, release & management of life science products with quality and compliance. This is most predominant in the medical device industry, where we find both medical devices that include software as a product component & Software-as-a-Medical-Device (SaMD) products that function as a medical device without the need for any hardware.

Claims Substantiation Seminar

Claims Substantiation Seminar

This two-hour training will be a scientific dive into the regulatory requirement of claims substantiation. Several topics including the following will be discussed along with real case examples: which types of evidence are available and where to find them; what are high quality and low quality evidence; when is the evidence irrelevant to the claim being made; and how to write claims that can be substantiated.

Cosmetic Safety Substantiation

Cosmetic Safety Substantiation

MoCRA, effective December 2023, requires safety substantiation. It amends the FD&C Act. MoCRA mandates maintaining safety records, facility registration, product ingredient registration, and reporting serious adverse events. This seminar, with insights from experts, will overview cosmetic safety assessment.