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.

Fenton Fong webinar

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