024 - Quality Management Systems Explained!

What We Covered 00:54 – Ed, Meranda and Brian welcome a special panel of guests to break down today’s topic: Quality Management Systems (QMS) Explained! 07:53 – The panel expounds on the timing necessary for QMS and what role the quality manual plays 13:06 – The panel explains the Code of Federal Regulations (CFRs) 17:30 – The panel defines Phase Appropriate as it pertains to QMS 23:12 – Identifying which guiding documents to follow 27:29 – The value in having an experience quality professional 31:54 – Why a quality agreement is necessary 35:32 – The panel provides final words of wisdom on Quality Systems Management Tweetable Quotes “Quality System Management provides an infrastructure for a company to ensure the quality of your drug product with patient safety in mind as its primary function.” “It helps determine and define management’s commitment to quality. Because if you don’t have senior management commitment, all could be lost.” “To begin at the beginning, when you set up your QMS, you need to start with the procedures and processes that will reduce risk and help you prepare for your submission in the long run. That would come through managing your documents.” “Guidance documents are just an opinion. And they actually say that in the documents. So, you kinda try to do a combination of everything.” “The biggest thing is that when you have somebody who’s experienced and they’ve been through various things like FDA audits or have worked with a very small company versus a very large company, they can differentiate what you really need right now.” Relevant Links Design Space InPharmatics – LinkedIn Design Space InPharmatics – Twitter Edward Narke on LinkedIn Bettina Kaplan on LinkedIn Susan Fasso on LinkedIn Robbi Freisem on LinkedIn Maria Arakil on LinkedIn

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024 - Quality Management Systems Explained! is an episode from CMC Live - Chemistry, Manufacturing & Controls by DSI.

This episode is 00:38:59 long.

This episode was published on Mar 5, 2021.

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