Establishing a Culture of Quality
The purpose of this whitepaper is to show the effectiveness of a well-structured management review process and prove that, by management reviewing quality indicators, they can instill into the company ...
Guide To IQ, OQ, and PQ In FDA-Regulated Industries
In FDA-regulated industries, there are a variety of standardized qualifications that a product must meet post-manufacture. In the Life Sciences industry, that means medical devices go through a series of ...
How The Life Science Industry Can Remain FDA Compliant in 2022
The coronavirus pandemic was a deeply disruptive, global event that sent ripples through just about every industry and occupation. While the Life Science industry has played a central role in ...
Quality and the Pharma-CMO Relationship
Just how connected are quality and the pharma-CMO relationship? As the FDA begins to rein in the regulatory free-for-all that was the COVID-19 emergency use authorization (EUA) process, it has ...
Why You Need a Strategy for QMS Oversight in the post-COVID Era
The temporary halt of routine onsite FDA inspections in early 2020 forced some drug and device manufacturers into product development limbo, and others had to rethink their strategy for QMS ...
Remote GxP Inspections
Remote FDA Inspection Audit Maintaining GMP and GCP Inspection Readiness in a Remote-Audit World Medical device, pharmaceutical and life science companies are feeling the impact as the coronavirus pandemic forces ...
Writing Effective QMS SOP’s
The quality management system (QMS) is the foundation of success for any organization that manufactures regulated products. The quality system reaches departments across the entire product lifecycle, from design and ...
FDA Compliance and Quality Trends for 2020
The fields of regulatory science and quality management are constantly changing as industry needs shift and new regulations are enacted to ensure product safety. As new technologies and therapeutic options ...
What’s So Great About the Life Science Industry? Everything!
At Premier FDA Solutions, our business is to help ensure the quality of life-saving and life-enhancing products our clients have developed and/or manufactured, and its availability to patients in need ...
