cGMP Responsibilities for Own Label Distributors and Brand Owners
This webinar will help you understand how to meet the requirements of an Own Label Distributor and comply with FDA regulations.
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
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)
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.
21 CFR Part 11 (Electronic Records & Signatures) Compliance for Computer Systems Regulated by FDA
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated, or “GxP” computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.
FDA’s 21 CFR Part 11 was enacted in 1997 and implementation success across the pharmaceutical and other regulated industries has been mixed. There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic, or system of record.