Quality Management Systems for Small Pharma Firms

Are you responsible for the quality management system (QMS) at a small pharma firm?

xCellarate Managing Director and Principal Consultant, Fenton Fong presented the Redica Systems webinar, “How to Build and Implement a QMS for Small Pharma and Biotech Firms,” on March 30.

He provided high-level insights for small pharma companies based on his GMP experience in the industry. 

The webinar was summarized in four parts:

1. How Can a Small Pharma Firm Begin Building a Robust QMS?
   Fong reviewed the GMP requirements for building a strong QMS.
2. Taking a Risk-Based Approach to QMS
   A look at the ICH quality guidelines and why they are important for a QMS.
3. What GMP Documents Does My QMS Need?
   Fong explained which GMP documents should be included in a QMS.
4. Can a Robust QMS Lead to Reduction of 483 Observations?
   An analysis of regulatory enforcement trends in 2020 and how a QMS can address common inspection observations. 

If you missed the webinar, you can download the recording and slide presentation here.