Validation of Non-Product Software

When used as intended, process validation can provide increased process reliability, confidence, improved yields, and reduced operating expenses significantly.

• Compliance to 21 CFR Part 820.70(i) Automated Process is required for Medical Device Manufacturers
• FDA inspectors are now being trained to evaluate software validation practices.
• Increasing use of automated manufacturing and quality systems means increased exposure.
• Most recalls can be traced back to computerized equipment, exposing the validation process to scrutiny.
• Corporate uncertainty leads to inaction and ‘wheel spinning’.
• A third of recent warning letters included citations with respect to improper or ineffective validation.

Why You Should Attend:

If a Medical device manufacturer is using software to automate a process that is required by FDA, it is essential to show that the software accurately, reliably, and consistently meets the requirements for its intended use.

Does that mean you need to do it simply because FDA says so? At the simplest level, yes. But why is FDA so interested in how software works? FDA isn’t as interested in the software itself as it is in the processes that the software is automating. FDA wants to be sure those processes are accurate, reliable, and consistent.

This course will teach how to comply with 21 CFR Part 820.70(i) and effectively implement a software validation program for medical devices, meeting the FDA requirements and produce a safe product. We will explain the role of Risk Management in Non-Product Validation. How software requirements are used in validation will be described.

Areas Covered in the Session :

• Software used as part of the manufacturing process (including software embedded in machine tools, statistical process control software, programmable logic controllers [PLCs], and software in automated inspection or test systems).
• Software used in process validation (such as statistical calculation software, spreadsheets, etc.).
• Software used in design and development processes (such as CAD software, CAM software, software development tools, software test tools, compilers, editors, code generators, etc.).
• Software used to automate part of the quality process (such as complaint-handling systems, lot-tracking systems, training-database systems, etc.).
• Software used to create, transmit, modify, or store electronic records that are required by regulation.
• Software used to implement electronic signatures for documents required by regulation.

Who Should Attend:

• Quality Assurance Departments
• Quality Control Departments
• Research and Development Departments
• Regulatory Affairs Departments
• Manufacturing Departments
• Engineering Departments
• Operations Departments
• Production Departments
• Validation Departments
• Documentation Departments
• Device Development Teams
• Personnel involved in Verification and Validation Planning, Execution and Documentation for Devices

Course Director: THOMAS BENTO

Thomas Bento is a student of Quality and Regulatory Compliance and has been supporting the design, development and compliance of Medical Device Manufacturing for 17 years. He started his career training in Software engineering and shortly moved into Commercial Software Quality. After many years of working for companies like Mitek Systems and Hewlett Packard, the decision was made to work in the regulated space of Medical Device Manufacturing, working at Edwards, Pulmonetic Systems, Regulatory consulting and SVP at Nihon Kohden America. Now he is Consulting for Philips Medical Systems. Through his experience he has found that the common thread that runs through the fabric of most Medical Device Manufactures is that more is better in order to meet regulatory expectations. He finds that this is the exact opposite and that manufacturers are better off by cultivating a simplified defensible approach to regulatory compliance founded on understanding and addressing Risk Management Appropriately.