Devicemakers Guide to Quality System Change Management

Danielle DeLucy
Jul 9, 2020 - 01:00 PM EST
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If you’re involved in any aspect of quality management systems (QMS) for your medical device, you need a strong change management process in place to avoid change interaction, where one change type triggers another change type.

Since QMS runs throughout your organization, it’s difficult to make a change in one area without impacting another.

Devicemaker’s Guide to Quality System Change Management breaks down QMS into separate areas where change may occur — device design, manufacturing processes, documentation and regulatory requirements. It explains the relevant requirements in the FDA’s quality management system regulations, the upcoming EU-MDR and the international standard ISO 13485. And it includes a template you can use to make sure each change element is properly addressed.


The webinar lays out a six-step plan for implementing change in the most cohesive way:

*Understand the difference between incremental change and step-shift change

*Identify change triggers

*Assess the business implications

*Ensure traceability through the steps of the change process

*Apply the process to specific change types

*Understand the interactions in the change types


Ensure a consistent approach to your change management process and avoid problems associated with ad hoc methods.


Who Will Benefit

Managers and supervisors of the following functions would benefit:

*Design Engineering

*Regulatory Affairs

*Quality Management

*Risk Management

Webinar Events
Attend Live Webinar
Jul 9, 2020 - 01:00 PM EST

Duration: 90 Minutes

Single Attendee

Group of 3 to 5 +1 Thumb Drive or 5 online Recorded version

Group of 6 to 10 +1 Thumb Drive or 10 online Recorded version

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Danielle DeLucy, Pharmaceuticals, Biotechnology

Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.

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