Frequently Asked Questions

Why is design controls training important?

The design controls section of 21 CFR 820.30 can be one of the most challenging regulations to understand and implement due to the inherent complexity of medical device product development and due to regulation ambiguity. An incorrect understanding of design controls regulation may lead to inadequate medical device development activities and documentation. Inadequate development activities and documentation may potentially lead to FDA observations which may impact a business's bottom line.  Design controls training is highly recommended for medical device professionals that are new to design controls or would like to increase their design control knowledge to enable them to more effectively implement design control concepts.

What will I learn during the design controls training course?

Depending on the design control training course chosen (Basic or Advanced), see course descriptions listed above and follow links to course agendas.

Will I be able to effectively implement a design controls process after I complete the design controls training?

After completing the basic  design control training course, attendees will sufficiently understand design control concepts and principles which will enable attendees to effectively function in an established design control process

How much of the design controls training course is hands-on versus lecture? 

The key objective of Procenius's design controls training is to promote effective and efficient learning. During the design controls training, examples and hands on case studies are used as often as possible to solidify the key concepts and principles. See the descriptions above and associated agendas for more specifics of each course.

Will the design controls training course help me understand the difference between design validation and design verification? 

The basic design controls training course provides an overview of the major differences between design validation and design verification. The advanced design controls training course performs a deep dive into the differences between design validation and design verification.

How much will the design controls training course cover software development and validation? 

The basic design controls training course will moderately cover software validation but neither course will provide an in-depth software validation review.

What is the typical class size for the design controls training course? 

Depending on the location and season, design control training classes sizes range from 5 to 20 attendees

Is the design controls training courses able to be customized for onsite instruction?

Yes, our design control training course directors will contact our clients prior to the class and can customize the examples and instruction to be applicable to a particular industry or product.