Welcome to the 25th 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!
Today’s episode is all about leveraging a risk-based approach to develop, implement, and maintain your IT programs, extending to GxP controls and critical infrastructure. Guest industry expert, Phil Becker, will be joining Mandy today to discuss this topic and to provide guidance!
Phil has over 30 years of experience in the IT field. He’s an industry thought leader who’s held various strategic leadership roles, including Vice President of IT at Acculogix and Fisher Clinical Services, where he was Chief Architect and Developer of the first truly integrated 21 CFR part 11 compliant electronic batch record in the pharmaceutical supply industry. Phil has also developed the industry’s first web-based reporting software integrated solution. His vast experience in the space includes software application development, architecture, design for manufacturing, and regulatory compliance.
With Phil’s extensive background in the IT space and pharmaceutical arena, he will be providing some incredible guidance on what listeners should consider in terms of IT controls, which risk management tools and approaches you should be taking a look at, and other tactical considerations that will help with the developments and enhancements of your IT program and critical process controls.
[:35] About today’s episode.
[1:50] Mandy welcomes Phil to the podcast!
[2:49] How can a risk-based approach be leveraged to develop and implement an IT control strategy to support GxP business systems?
[7:52] What are some risk management tools and approaches that are effective to assess the types of critical controls and the level of robustness that’s appropriate for business systems?
[17:47] In regards to business continuity, what are some of the key inputs that should be considered for implementing and maintaining the business continuity program? And how can the effectiveness of these programs typically be assessed?
[28:14] Mandy thanks Phil for joining her this episode!
[30:30] Mandy thanks you all for tuning in for this week’s episode. If you want to get in touch with her, you can contact her at Mandy.Podcast@Solabs.com.
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