From Paper to Paperless-Tackling the 21CFR11 Challenge 6/6/2019

Today, both the MHRA and FDA are highly focused on data integrity and discourage methods which manually record data. Modern data management systems provide secure data transfer, automated reporting without data integrity fears, and electronics batch release approval processes.

 

Complying with the new requirements present more challenging requirements. Bringing manufacturing processes and controls to a new level can appear simple in theory but provides many challenges in application.

 

Using the example of a standard Data Management implementation, this presentation provides a variety of insights including:

             Mitigating the risks of unplanned for steps.

             Fulfilling Data Integrity requirements.

             Leveraging the project to enhance process efficiency and Quality System Management compliance to recent regulations.

 

 

Date: June 6, 2019

 

Choose a link to register:

10:00am Central European Time

11:00am Eastern Time

 

Speaker

Daniele Pandolfi

Global Product Line Manager, Aerosol, Particle Measuring Systems

Daniele Pandolfi is the Global Product Line Manager, Aerosol in Particle Measuring Systems’ Life Science Division. He has over eleven years’ experience in particle counter instrumentation and cleanroom contamination control, focusing on strong customer relationships. He has helped many cleanroom users solve their cGMP issues. Mr. Pandolfi has been responsible for the EMEA Service Department, and a member of the Global Life Science organization in 2015.

Speaker

Maurizio Della Pietra

Global Data Management Specialist and Process Advisor, Particle Measuring Systems

Maurizio Della Pietra is the Global Data Management Specialist and Process Advisor for Particle Measuring Systems. In this role, he collaborates and consults with pharmaceutical companies and with developers of pharmaceutical equipment and isolation technologies for improving the sterility assurance on science-based strategies. His expertise includes QA processes, validation of equipment, utilities, facilities, computer systems, aseptic production processes, and statistical analysis of aseptic production processes. He has earned a Master's Degree in Physics.