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Medical Device QMSR (ISO 13485)

Medical Device QMSR (ISO 13485)

This webinar will highlight the major changes to the regulations and give an overview of how the regulations have updated. Also covered are implementation of the new final rule, and what steps to take to best prepare for the start of enforcement by the FDA.

Health Canada

Health Canada

Interested in doing business of health products in Canada? This free webinar provides an overview of the Canadian regulation on natural health products and how EAS can assist companies with the diverse requirements of Health Canada.

Transition from Computer System Validation (CSV) to Computer Software Assurance (CSA)

Transition from Computer System Validation (CSV) to Computer Software Assurance (CSA)

The life science industries, including pharmaceutical, medical device, biotechnology, biological, and tobacco and tobacco-related products continue to embrace new technology to improve delivery of quality products in compliance with FDA. In addition, we’ve seen a trend toward making use of cloud services, Software-as-a-Service (SaaS) solutions, and other technical innovations such as use of Artificial Intelligence (AI), Machine Learning (ML) and Large Language Models (LLMs), such as ChatGPT that have more recently begun to be used more heavily in life science companies.