An intensive two day course presented in conjunction with Software Quality Consulting, Inc.

Developing software in compliance with FDA regulations and international standards is no easy task. This two-day intensive course provides your organization with practical guidance and suggestions for developing software that complies with applicable FDA regulations, guidance documents and international standards. The focus of this course is interpreting Design Controls for software. Each section of the Design Controls regulation (820.30) is discussed from the perspective of software. Discussions on critical topics such as Requirements, Design Reviews, Software Verification & Validation and Risk Management are included. In addition, requirements for validating software development tools and software used in Manufacturing and Quality Systems are also discussed. Interactive group exercises are included to facilitate discussion and learning.

Course hours are 8:30am – 4:30pm on August 5th and 6th.  Fee includes all course materials and meals.

Who Should Attend

Software engineers, project managers, quality managers, software quality professionals, and anyone who needs to develop cost-effective processes and procedures that will enable their organizations to deliver high quality devices that comply with FDA regulations, guidance documents and international standards.