Design Control Compliance for FDA & ISO
Design Control Compliance for FDA & ISO
(On-site or Virtual Private Group/Company Training)
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Overview:
FDA investigators are inspecting and pursuing enforcement activities
for non-compliant Design Control violations. FDA has published that 68% of firms inspected had potential design control non-compliance and 55% of Warning Letters cited Design Control violations. As one of the four major subsystems within FDA's QSIT inspection program, expect your Design Control System to be inspected. Warning letters published repeatedly cite Design Control deficiencies. Design Control is also a very important element of ISO 13485 in which non-compliance can result in the risk of losing your CE Marks and therefore the ability to market your devices internationally. This program discusses Design Control, the regulatory requirements (U.S. & International), and methods for implementing and maintaining a successful Design Control process. A poorly implemented Design Control process can add delays and frustration to R&D teams while an efficient Design Control system will allow teams & companies to be remain creative, meet schedules, and stay compliant. Design Control Flowcharts will be provided to
assist with modeling of Design Control procedures and the implementation of
an efficient Design Control program. This course is applicable to R&D and RA/QA personnel who are responsible for their company's Design Control program. It is very beneficial for R&D engineers, QA engineers, RA, Management, Marketing, and Manufacturing personnel who participate in the design control process or may be members of a design team.
What you will learn:
- How to comply with FDA & ISO (including ISO 13485:2016) requirements for Design Control.
- FDA expectations and requests during your Design Control Inspection.
- Design Control process requirements, Guidance, & implementation concepts.
- Integration of Risk Management and Usability in Design & Development processes.
- FDA's required Design History File (DHF), its content & level of detail.
- How to overcome the biggest problems in implementing Design Control.
- How to implement Design Control and Design Reviews that shorten the development cycle rather than waste time and create internal friction.
- How design control compliance will impact your 510k, PMA & IDE submissions.
- Implication of ISO 13485:2016 on your Design Control process.
Benefits of Attending:
- Ability to pass a Design Control Inspection by FDA
- Compliance with FDA GMP/QSR, ISO 13485 requirements
- Preparation for FDA Investigator questions during a Design Control Inspection
- Reduced threat of Design Process related Enforcement Actions
- Shortened product development time, better, and safer products through a well managed Design Control Process
- Minimized Product Liability risks
- More rapid 510(k), PMA, IDE, CE Mark submission approvals
- How Design Control is used in a Special 510(k)
- Prepare for the Design Control requirement for IDE submissions.
Abbreviated Outline:
- A. Introduction to Design Control, Design Control Flowcharts
- B. Latest FDA regulations for Design Control & FDA Guidance Documents
- C. FDA's Design Control Guidance- implications for Implementation & FDA Inspections
- D. ISO 13485 and International requirements for Design Control
- E. FDA & ISO Design Control Elements-regulation, guidance, & real world
- F. Design History File (DHF): what is required and how to construct
- G. When do you start Design Control & who should be the players
- H. How to schedule & implement Design Control elements and reviews
- I. The Design Review Process & Design Review SOP Template
- J. Assessing your process to avoid or eliminate roadblocks during development
- K. Human Factors Guidance Documents, FDA expectations & impact
- L. How to develop and maintain your Design Control Lifecycle & Process
- M. FDA's Inspection of Design Control Subsystems -How to prepare
- N. Avoiding problems during an FDA Design Control inspection
- O. Review & Summary
Instructor(s): To be determined based on schedule and your specific needs. All instructors are very experienced and experts in the field being taught. Biographies will be provided and a discussion with the instructor(s) will be arranged so that a proposal can be provided for training that meets your needs.
Duration: Standard course is approximately 8 hours. Customized courses can vary. On-site courses are typically taught in 1 day. Virtual courses can be taught over multiple days, e.g. 2 days for 4 hours/day, etc.
Request a training proposal for your company.