Quality Management Systems Explained!

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Quality Management Systems Explained!

Episode Summary

Bettina Kaplan is the Head of Quality Assurance Services, Robbi Freisem and Susan Fasso are Senior Quality Assurance Consultants and Maria Arakil is a Quality Assurance at Design Space InPharmatics. Together, this talented panel of subject matter experts join Ed, Meranda and Brian to discuss all things Quality Management Systems. QMS are highly complex and many organizations struggle to implement them. They discuss a brief history of QMS, the timing required and guiding documents, such as the Code of Federal Regulations. They talk about reasons why quality agreements are necessary and the value in hiring an experience quality professional.

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. Click To Tweet It helps determine and define management’s commitment to quality. Because if you don’t have senior management commitment, all could be lost. Click To Tweet 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. Click To Tweet Guidance documents are just an opinion. And they actually say that in the documents. So, you kinda try to do a combination of everything. Click To Tweet 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… Click To Tweet

Links Mentioned

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