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Kandungan disediakan oleh SOLABS, Mandy Gervasio, and Philippe Gaudreau. Semua kandungan podcast termasuk episod, grafik dan perihalan podcast dimuat naik dan disediakan terus oleh SOLABS, Mandy Gervasio, and Philippe Gaudreau atau rakan kongsi platform podcast mereka. Jika anda percaya seseorang menggunakan karya berhak cipta anda tanpa kebenaran anda, anda boleh mengikuti proses yang digariskan di sini https://ms.player.fm/legal.
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Episode 54: Risk Management Tools and Techniques with Michael Tyo

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Manage episode 399578259 series 2364916
Kandungan disediakan oleh SOLABS, Mandy Gervasio, and Philippe Gaudreau. Semua kandungan podcast termasuk episod, grafik dan perihalan podcast dimuat naik dan disediakan terus oleh SOLABS, Mandy Gervasio, and Philippe Gaudreau atau rakan kongsi platform podcast mereka. Jika anda percaya seseorang menggunakan karya berhak cipta anda tanpa kebenaran anda, anda boleh mengikuti proses yang digariskan di sini https://ms.player.fm/legal.

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. In this episode, guest Michael Tyo joins Philippe Gaudreau in a discussion on risk management tools. They discuss the importance of a risk plan and a risk assessment SOP, plus the FDA’s expectations regarding the use of risk assessment tools.

Key Takeaways:

01:11 Introducing Michael and his Background

02:31 Does the FDA have a clear expectation for the use of risk assessment tools?

06:13 The importance of a risk plan

09:20 Why companies must all have an SOP for risk assessment

Contact us at solabs-podcast@solabs.com

  continue reading

59 episod

Artwork
iconKongsi
 
Manage episode 399578259 series 2364916
Kandungan disediakan oleh SOLABS, Mandy Gervasio, and Philippe Gaudreau. Semua kandungan podcast termasuk episod, grafik dan perihalan podcast dimuat naik dan disediakan terus oleh SOLABS, Mandy Gervasio, and Philippe Gaudreau atau rakan kongsi platform podcast mereka. Jika anda percaya seseorang menggunakan karya berhak cipta anda tanpa kebenaran anda, anda boleh mengikuti proses yang digariskan di sini https://ms.player.fm/legal.

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. In this episode, guest Michael Tyo joins Philippe Gaudreau in a discussion on risk management tools. They discuss the importance of a risk plan and a risk assessment SOP, plus the FDA’s expectations regarding the use of risk assessment tools.

Key Takeaways:

01:11 Introducing Michael and his Background

02:31 Does the FDA have a clear expectation for the use of risk assessment tools?

06:13 The importance of a risk plan

09:20 Why companies must all have an SOP for risk assessment

Contact us at solabs-podcast@solabs.com

  continue reading

59 episod

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