Specificities of GCP Quality Systems

(Original airing date: 26 Nov 2019.  Duration: approximately 15 minutes)

The focus of this episode is the specificities of GCP quality systems. Mandy and Philippe are joined by special guest, Nathalie Bourgouin, VP of Compliance at Skillpad. Skillpad is a sister company of Solabs and Philippe has had the pleasure of collaborating with Nathalie over the years. With more than 25 years of experience in pharmaceuticals and biotech in North America and Europe, Nathalie is a leader in compliance, quality, and project management, with a solid background in risk-based quality assurance processes, training, and auditing. She has planned and audited many GMP and GCP vendors, as well as numerous clinical sites in local and global studies.

The conversation with Nathalie today will surely help companies improve their quality levels. Some key topics discussed today include: the difference between GMP and GCP quality systems, how Nathalie has seen the global regulatory landscape change, the key variables to consider with GCP event management, and specific tools that can be utilized to help streamline the process.

To learn more, you can reach Nathalie and the Skillpad Compliance Team at: compliance@skillpad.com