Episode 3: Phase Appropriate Quality with Mary Senica

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This episode has been published on July 23rd, 2018

Welcome to the third episode of Automating Quality. Today’s topic is phase appropriate quality — a topic that is especially relevant for anyone in the life sciences industry. Mandy is joined by her co-host, Philippe Gaudreau, CEO of Solabs; and industry veteran, and the Vice President of Quality and Compliance from Eirion Therapeutics, Mary Senica.

In this episode, Mandy and Mary take a deep dive into a lot of critical components of quality and supporting processes. Mary gives her advice to growing companies and explains how to design processes so they’re appropriate for your organization or the product that you’re manufacturing.

There’s a lot of fantastic takeaways this week, such as: key factors to consider when looking to implement an electronic solution, how to determine when a software solution is warranted within a company, what makes a successful training program, and the basic principles to consider as part of a company’s CMC practices.

Key Takeaways:

[:20] About today’s guest, Mary Senica.

[1:09] About Mary’s background and industry experience, and her primary role at Eirion Therapeutics.

[2:36] What are the specifics GMPs and regulatory guidance related to the drug development process?

[4:18] When looking for an electronic answer or solution to a compliance system, what are some key factors to consider?

[10:10] How to determine when a software solution is warranted within a company.

[16:58] Why it is so important to implement a system that allows everyone to function together effectively.

[18:34] What makes a successful training program.

[22:05] What are the expectations for GMP equipment as a company moves through the phases of the product development life cycle?

[26:06] The basic principles that must be considered as part of a company’s CMC practices.

[28:50] What advice Mary would give a growing organization as they mature through the product life cycle (in regard to implementing key electronic solutions.)

[31:48] Wrapping up the episode with Mandy, how to contact Mary and about next week’s episode.

Mentioned in this Episode:

Eirion Therapeutics

GMP

CFR

CMC

FDA.gov

Previous AQ Episode: Optimizing Compliance When Implementing an Automated Training Solution with Jay Turner

AQ Episode 1: Change Management with Rachel Fountain

Mary Senica’s Linkedin

Mandy.Podcast@Solabs.com