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The Specificities of GCP Quality Systems with Natalie Bourgouin

- 1 October 2018

Welcome to the eighth episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! She’s joined by her co-host, the CEO and founder of Solabs, Philippe Gaudreau.

The focus of this week’s show is the specificities of GCP quality systems. Mandy and Philippe are joined by special guest, Natalie Bourgouin, VP of Compliance at Skillpad. Skillpad is a sister company of Solabs and Philippe has had the pleasure of collaborating with Natalie over the years. With more than 25 years of experience in pharmaceuticals and biotech in North America and Europe, Natalie 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 Natalie today will surely help companies improve their quality levels. Some key topics discussed today include: the difference between GMP and GCP quality systems, how Natalie 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.


Key Takeaways:

[:34] About today’s topic and guest.

[1:45] Natalie introduces herself and talks about her background in quality and compliance.

[3:30] How are the GMP and GCP quality systems different? And what are the idiosyncrasies of a GCP system?

[5:17] How has Natalie seen the global regulatory landscape change? And is this driving a new approach for managing clinical event occurrence?

[7:20] What Natalie sees as a few key variables to consider (as related to GCP event management).

[9:34] Natalie explains the type of approach that can be implemented to enhance the traceability and robustness related to clinical events that occur in the field.

[13:04] Are there any specific tools that can be utilized to help streamline the process?

[15:53] How does Natalie see this approach, relating to the new ICH E6 guidance, in regard to data integrity?

[21:18] How to get in touch with Natalie or Mandy.

[21:54] About next week’s episode.


Mentioned in this Episode:

GCP and GMP basics

ICH E6 (R2)