A strong Quality Management System (QMS) is a critical necessity for any pharmaceutical or biotech firm producing products for market, regardless of company size.  If your QMS is inadequate, a regulatory inspector will not care if your company is a small firm, even if manufacturing is outsourced to another organization.

How can small pharma firms ensure their QMS is strong?  What are the requirements for a robust QMS?  Why should firms be concerned about data integrity?

On March 30, Founder, Managing Director and Principal, xCellarate Technology Consulting Inc., Fenton Fong, presented Redica Systems webinar, “How to Build and Implement a QMS for Small Pharma and Biotech Firms.”

Fenton Fong webinar

What You Will Learn

  • The common challenges small pharma firms face when developing a QMS
  • Recent enforcement trends involving the Quality Unit
  • The impact of the COVID-19 pandemic

Who Will Benefit

This webinar will be valuable to directors and managers at small pharma and biotech firms responsible for manufacturing quality in addition to any stakeholders with interests in this space.

About the Presenter

Fenton Fong

Fenton Fong has over 25 years of corporate and consulting experience in pharma, biotech, and related industries.  He is an ISO9001:2015 certified lead auditor and a member of the Editorial Board of the PDA Journal of Pharmaceutical Science and Technology (JPST). His experience includes QA management, manufacturing facility operations, and CMC for a blockbuster parenteral product NDA.  He has engaged innumerous audits, GMP and QMS remediation projects, both domestic and international.

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Quality Management Systems for Small Pharma and Biotech Firms

Webinar: QMS for Small Pharma and Biotech Firms

Presented on Tuesday, March 30, 2021
by Fenton Fong, Founder, Managing Director, & Principal at xCellarate

Download the slide deck and video of this informative 1-hour webinar on the common challenges small pharma firms face when developing a QMS.

What you will learn:

  • Common challenges small pharma firms face when developing a QMS
  • Recent enforcement trends involving the Quality Unit
  • Impact of the COVID-19 pandemic

Download the Special Report

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In this summary we identify:

GMP data from FY2017 to FY2020 for the Asia-Pacific region

Top 3 GMP primary and secondary citations

Top 3 483 observations

Download the Special Report

An Analysis Of MHRA’s Latest Annual GMP Inspection Deficiencies Report

In this summary we identify:

  • Data from 2019 UK MHRA Inspections
  • Trends from 2015, 2016, 2018, and 2019 inspections
  • Conclusions drawn from an analysis of drug inspection data

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