Design Control Requirements - Integrating the Quality System Regulation

Upcoming Hybrid Courses

Upcoming Virtual Courses

Quality Systems

Design Control Requirements - Integrating the Quality System Regulation

May 1 to May 3, 2024

Quality Systems

Design Control Requirements - Integrating the Quality System Regulation

Jul 16 to Jul 18, 2024

Quality Systems

Design Control Requirements - Integrating the Quality System Regulation

Sep 10 to Sep 12, 2024

Overview

This intensive 3 – day course provides complete coverage of design control requirements for FDA Quality System Regulation, ANSI/AAMI/ISO 13485:2016, and the Medical Device Single Audit Program (MDSAP). With the participation of FDA representatives during the entire course, attendees have the unique opportunity to participate in a shared learning experience.

Objectives

Upon completing this course, participants will be equipped with the information to able to evaluate the degree of compliance of a design control system, including identification of noncompliance issues, and be prepared to implement the improvements needed to meet requirements.
This highly interactive course engages the learner with in-depth discussion of industry best practices to learn how industry leaders address design control challenges. Exercises are designed to build a solid understanding for developing and applying design control requirements. Attendees will participate in structured discussions with their peers to develop solutions to solve current issues.
Examples of design control tools, templates, and practices, in use by medical device companies, stimulate discussion and provide a practical resource for future reference. Case studies and situation analyses are used throughout the program to help participants analyze potential areas of noncompliance, identify improvements, and evaluate the various methods of managing a design control program.
Course content is the culmination of years of consensus development on the part of a respected group of quality system experts from leading device manufacturing companies, FDA, and industry consultants.

Who Should Attend?

Instruction is targeted to professionals involved in meeting design control requirements such as those in regulatory affairs, quality assurance, design engineering, manufacturing, operations, and members of research and development or new product development teams.

Materials

Fee includes a printed copy of the textbook, The Quality System Compendium, and electronic versions of the PowerPoint presentations and case studies, pertinent FDA documents, additional references, and access to the online exam.

Virtual Training Information

Our virtual training environment allows you to have direct interaction with your instructors and your fellow attendees. AAMI uses Zoom for virtual classes. You can test your connectivity and ability to use Zoom at zoom.us/test.
For virtual training courses, we request that you register at least one week in advance of the course start date to allow sufficient time for shipping of training materials and devices (Please allow two weeks for non-U.S. addresses). If you register within these time frames, AAMI cannot guarantee you will receive material prior to the start of the course but you will have access to digital versions of the materials. If you have any questions, please email education@aami.org.

Speakers

Samir Paliwal

Director for Quality, PerkinElmer

Samir Paliwal is Sr. Director for Quality at PerkinElmer, an Environmental, Food and Human Health company. Prior to joining PerkinElmer, he worked at Allergan, CR Bard and Covidien (now Medtronic) holding various positions in Quality and Operations. He has over 20 years of experience in the industry and has held positions primarily in Quality Assurance, and also in Product Development, Operations and Regulatory Affairs. His work experience includes development and management of quality systems, new product development and launch, post market surveillance, risk management, supplier management, and due diligence assessments to support acquisitions.

Philippe Joly

Founder, e@syGMP

Philippe Joly is the founder of e@syGMP, a training and consulting firm.  He works mainly with European-based client firms to establish cGMP/QSR-compliant quality systems or to improve the efficiency of the existing ones. He has 10 years of experience in developing and delivering training on cGMP/QSR. Prior to this job, Philippe Joly has been involved in sales, marketing and product development for two international companies involved in the biopharmaceutical and medical device market.