How to handle Human Errors in Pharmaceutical Manufacturing

About the webinar
Failure to meet requirements or specifications in Pharmaceutical Manufacturing needs to be addressed by senior management in a compliant manner. An analysis of recent FDA citations reveals that many of the failures are attributed to “human error.” This educational Session will address :
What is Human error ?
How to perform a failure investigation ?
What Methodology should be followed to determine a root cause?
What documentation is required to support a root cause?
What are the risks and their impact on the organization?
Can only training be an acceptable CAPA ?
What should be the role of Senior management ?
Importance of trending
Impact of Quality culture
Importance of Reward and recognition
About the Presenter
Dr. M.Damodharan M, Sr. Vice President - Global Quality & Regulatory Affairs - Sai Life Sciences Ltd, has more than 26 years of varied experience in Pharmaceutical Industry in companies like GSK and Ranbaxy. He has implemented self-sustained Quality Management Systems and all time inspection readiness strategies, performed 100 + audits across the globe, successfully handled various regulatory agencies audits including USFDA, implemented integrated electronic systems.
He was a contributing author of the ISPE Good Practice Guide: Technology Transfer ( Small molecule case study # 3: Development to commercial at CDMO)