This design controls training webinar was originally recorded in 2014, and the webinar is now being updated for the 2019 best practices.
Design controls are the #1 cause of FDA 483s. Design controls are 1 of 4 major quality subsystems that FDA will review during a QSIT level II inspection, and design controls are one of the biggest challenges for companies developing a medical device for the first time.
What is covered in Design Controls Training Webinar?
Our instructor, Rob Packard of Medical Device Academy, reviews basic concepts and requirements of each design phase of the design process from design plan approval through commercial launch approval, including:
- Design planning
- Design inputs
- Design outputs
- Design verification
- Design validation
- Design reviews and more.
The Phase Gate Approach-concept and benefits. You will learn how large companies manage product design-related projects (5-6 hard gates) and keep them on schedule.
The lifecycle loop-(Post Market Surveillance, Risk Analysis, and Clinical Evaluation Reports) is illustrated to explain why docs should be updated on a regular basis.
Numerous diagrams are utilized throughout the presentation.One exclusive diagram shows you how to implement risk management throughout the design process.
Updates Regarding Human Factors & Usability Engineering
This webinar was updated on November 2, 2018. However, we recently recorded an updated usability webinar and released a usability procedure (SYS-048). After listening carefully to the webinar, and reading through the usability procedure, I decided to update our combined design/risk management plan to specify formative testing during phase 3 and summative (validation) testing during phase 4 of the design process. You can always modify your own design plans to include this requirement or provide a rationale for why it is not needed for your project. However, my goal was to help explain the value of formative testing and its role relative to summative testing. Minor changes were also made to the design procedure (SYS-008) to match.
These changes are reflected in the current webinar that we updated for 2019 and re-recorded on October 8, 2019. If you are interested in purchasing our usability procedure and template for summative (validation) usability testing, please visit our newest webpage for the usability procedure (SYS-048). Our updated usability webinar, is also available.
Cost is $129 (AND INCLUDES NATIVE SLIDE POWERPOINT PRESENTATION FILES):
This webinar was first created in 2014, but we are updating the material for 2018 best practices. The focus of this webinar is to coach companies that are implementing design controls for the first time. Our goal is to make the process simple and straightforward. We will also be sharing a new template for creating a combined design and risk management plan. We will also explain how to identify the regulatory and testing requirements as design inputs for your project.
Exam and Training Certificate available for $49.00:
This is a 10 question quiz with multiple choice and fill in the blank questions. The completed quiz is to be submitted by email to Rob Packard as an MS Word document. Rob will provide a corrected exam with explanations for incorrect answers and a training effectiveness certificate for grades of 70% or higher.
VIEW OUR PROCEDURES – CLICK HERE OR IMAGE BELOW:
About Your Instructor
Robert Packard is a regulatory consultant with 25+ years experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Robert was a senior manager at several medical device companies—including President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone 802.258.1881 or email. You can also follow him on Google+, LinkedIn or Twitter.