COURSE DESCRIPTION

OVERVIEW

In 2011 the Center for Devices and Radiological Health (CDRH) initiated the Case for Quality, a new program that identified barriers in the current validation of software in medical devices guidance (released in 2002). Now, CDRH — in cooperation with the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) — is preparing to release new guidance, Computer Software Assurance (CSA) for Manufacturing, Operations and Quality Systems Software, recently delayed until February 2021.

As pharmaceutical companies perfected their business processes and became more efficient in validating computer systems, the piles of documentation continued to grow without significant quality benefits. The focus was on speed, documentation accuracy and completeness, inspections, audits, and complying with the regulation.

Transitioning to the new guidance will require unlearning “the old,” and relearning how to apply CSA. The emphasis is on critical thinking, risk management, patient and product safety, data integrity, and quality assurance. Even though this guidance is being developed for the medical device industry, the FDA has indicated it should be considered when deploying non-product, manufacturing, operations, and quality system software solutions, such as quality management systems (QMS), enterprise resource planning (ERP) systems, laboratory information management systems (LIMS), learning management systems (LMS), and electronic document management systems (eDMS).  As such, the guidance will be applicable to research and development (R&D), clinical, laboratory, and other groups within pharmaceutical, biopharmaceutical, and medical device companies that are currently meeting the regulations for electronic records and electronic signatures (ERES) and computer system validation (CSV).

This two-part webinar will give you a foundation for understanding the guidance, if (and how) it is right for you, and steps to practically assess benefits and apply the guidance. Session one will provide definitions on critical thinking, risk management, patient and product safety, data integrity, and quality assurance. Session two focuses on how to transition from CSV to CSA leveraging CSV methodology, business processes, and risk management.

LEARNING OBJECTIVES (SESSION ONE)

At the completion of this session, you will be able to:

• Explain the differences between Computer System Validation (CSV) and Computer Software Assurance (CSA) and short- and long-term benefits of moving to CSA
• Define and discuss key terms and concepts being introduced with CSA to include critical thinking and risk management
• Define and discuss patient and product safety, data integrity, and quality assurance
• Build foundational knowledge required to transition from CSV to CSA

LEARNING OBJECTIVES (SESSION TWO)

At the completion of this session, you will be able to:

• Recap learnings from Webinar Part 1 – the differences between Computer System Validation (CSV) and Computer Software Assurance (CSA); and short- and long-term benefits; terms and definitions; and patient and product safety, data integrity, and quality assurance
• Provide an approach to plan for CSA transition to include people, process, technology and product.
• Develop quality metrics (qualitative and quantitative) on organizational performance: people, process, project and technology
• Create a Transition Plan – with a phased road map for a successful transition to CSA