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Summary:

On the Floor QA

Where innovation meets sterile manufacturing

On the floor QA is a critical aspect to a sterile drug's quality assurance as it ensures compliance to GMP production and facility requirements. 

This webinar focuses on understanding how QA interfaces with manufacturing and quality control to enhance the production compliance and quality of the product. Our speaker will review both the high level role of the department to a detailed look at their day to day operations then describe practices used at Berkshire Sterile Manufacturing, a fill finish CMO with a reputation for quality.

What does it mean? | What does it look like?

Speaker:

Topics to be covered:

  • What on-the-floor QA entails
  • The building blocks to an effective system
  • Day to day operations
  • How to mitigate friction between groups
  • Ensuring all parties are invested in the highest quality production
  • An organizational structure that can work with all sizes of production
  • What you might need to know if you are outsourcing to a manufacturer 

Kenneth Bosley

BSM Senior Manager, Quality Assurance

ON THE FLOOR QA

Kenneth Bosley

BSM Associate Director, Quality Assurance

What it means | What it looks like

Ken has 16 years of experience working for GMP biotech manufacturing facilities in QA and QC. He is currently the senior manager of QA shop floor at BSM. His group oversees all cGMP production.

11:00AM - 12:00PM EST  | Wednesday, September 16th, 2020

11:00AM - 12:00PM EST

Wednesday, September 16th, 2020