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.”
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 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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