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:
- How Can a Small Pharma Firm Begin Building a Robust QMS?
Fong reviewed the GMP requirements for building a strong QMS.
- Taking a Risk-Based Approach to QMS
A look at the ICH quality guidelines and why they are important for a QMS.
- What GMP Documents Does My QMS Need?
Fong explained which GMP documents should be included in a QMS.
- 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.
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