024 - Quality Management Systems Explained!

CMC Live - Chemistry, Manufacturing & Controls

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