All FDA Regulated Industry Webinars

• 60 Mins

If you work in the GMP-regulated industry, you not only need to address human error deviations because they are an inconvenience, but you must also do it because the regulation requires it. The CFR - Code...

By Internal Team

• 60 Mins

Computer system validations play a crucial role in the pharmaceutical, medical device, and many other FDA regulated industries to ensure the integrity, security, and compliance of critical computerized sy...

By Internal Team

• 60 Mins

Corrective and preventive action (CAPA) is required by ISO 9001:2015 and is also common sense; we don't want to have to solve the same problem more than once. The automotive IATF 16949:2016 standard adds...

By WILLIAM LEVINSON

• 60 Mins

We will explore the best practices and strategic approach for evaluating computer systems used in conducting FDA-regulated activities and determining the level of potential risk, should they fail, on data...

By Internal Team

• 60 Mins

Standard Operating Procedures (SOPs) are the backbone of Good Practice (GxP) compliance in the pharmaceutical, biotechnology, and medical device industries. Yet, despite the critical role SOPs play in dai...

By Internal Team

• 60 Mins

Training programs have evolved. Human reliability or human error is usually attributed to training effectiveness or training program weaknesses/strengths. Even though the training is considered the “vacci...

By Internal Team

• 60 Mins

Documents contained in the TMF must be available for inspection by the appropriate regulatory authorities at any time during and after the conduct of a clinical trial, and must be submitted to support the...

By Internal Team

• 60 Mins

This webinar describes:Enhance your knowledge: Compliance auditing is a critical aspect of any organization's governance framework. By attending this webinar, you will gain a comprehensive understanding o...

By JOSE IGNACIO MORA

• 60 Mins

This webinar addresses the Computer Software Assurance guidance related to 21 CFR Part 11, and the European equivalent Annex 11 for local and SaaS/Cloud-hosted applications. It details the evolution of in...

By Internal Team