Samsung Biologics

https://www.pharmtech.com/pt_w/validation

How can Validation be more efficient with documentation practices?

Utilizing risk based approaches with validation to be efficient and compliant.

Improving traditional documentation by use of pre-approved forms and master protocols.

Utilizing risk based approaches to be more efficient with routine revalidation, setting time intervals and activities based on risk.


Senior Director Quality Engineering
Samsung Biologics

Professional leader with over 29 years of Biotech and Pharmaceutical experience with expertise in Quality Assurance, Quality Control, Validation, Aseptic Processing, Technology, Utilities, and Engineering. A hands on leader with multiple qualification activities, managing quality, engineering, maintenance and validation personnel. Has overseen the introduction of new products, provided technical support for product development and continuous operations. Global experience with new and existing pharmaceutical facilities.

Webcasts

Tuesday August 31, 2021 at 11am EDT | 8am PDT | 4pm BST | 5pm CESTEfficiency for validation, changes to traditional practices to be more efficient and effective . 


Efficiency For Validation “Continuous Change and Improvement”

Articles

This application note describes key activities to accelerate biopharmaceutical tech transfer to support faster development and manufacturing programs.

Accelerating Biopharmaceutical Tech Transfer to Address Unmet Medical Needs

N-1 Bioreactor Perfusion Capability


•	How alternating tangential filtration differs from other perfusion methods

•	The benefits of alternating tangential filtration
