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How to perform your Process Validation for medical devices? (IQ OQ PQ) 4 года назад


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How to perform your Process Validation for medical devices? (IQ OQ PQ)

► Webpage: https://podcast.easymedicaldevice.com... Process Validation is a science but it needs also some education. In this episode of the Medical Device made Easy Podcast, we will help you understand what is Process Validation. If you are a Medical Device Manufacturer or if you are an engineer that wants to understand Process Validation, then this episode is for you. We will talk with Adnan Ashfaq from Pharmi Med Ltd. He will share with us his experience and provide some valuable tips to be successful within this process. Some of the topics we'll cover are: - FAT SAT IQ OQ PQ - Prospective and retrospective validation - Soft skills to be a good Validation Engineer - What is the most common issue in a validation process? - Validation templates. Don't hesitate to contact Adnan Ashfaq to help you with your Validation Process. ----------------------------------------------------------------------------------------------------------------------------- ► Who is Adnan Ashfaq? Adnan Ashfaq is a Quality, Regulatory & Validation Specialist with almost 20 years of experience in Medical Device, Biotech and Pharmaceutical industries. Adnan founded Pharmi Med in 2011 and has since been supporting Medical device companies around the labyrinth of regulations and assisting them in flying through successful audits. He has been working with start up companies and multinationals in developing new products since 1999. With regulations tightening up, especially in Europe, Pharmi Med is enabling and trying to help simplify the compliance conundrum to ensure manufacturers reach their desired market, and stay in the market. ----------------------------------------------------------------------------------------------------------------------------- ► Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare company and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses... -------------------------------------------------------------------------------------------- ► Links from the Video ■ Adnan Ashfaq Linkedin:   / adnan-ashfaq-44478121   ■ Pharmi Med Ltd: https://www.pharmi-med.com/ ■ Validation Toolkit to download: https://mailchi.mp/easymedicaldevice/... ■ Blog post Process Validation or Verification: https://easymedicaldevice.com/medical... ------------------------------------------------------------------------------------------- ► Social Media to follow ■ Monir El Azzouzi Linkedin:   / melazzouzi   ■ Twitter:   / elazzouzim   ■ Pinterest:   / easymedicaldevice   ■ Instagram:   / easymedicaldevice   ------------------------------------------------------------------------------------------ #medtech #medicaldevice #compliance

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