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.
“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.”
Design Space InPharmatics – LinkedIn