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Compared to bigger actions, Recalls, 483s, Warning Letters and consent decrees are only some of the milder parts of punishments that the FDA could impose on a medical device company that fails to meet regulatory requirements. The bigger actions can include seizure, injunction, and civil money penalties. The Park Doctrine allows executives to even be sentenced to prison.
In the legal sense, strict liability means that a prosecutor does not need to prove criminal intent. Any other means, such as media exposure, customer injury and death, and class action lawsuits can mean total disaster for a business. This makes it absolutely imperative for every responsible person in a medical device company, such as executive, general manager, quality leader, and management representative to understand these consequences.
Understand ways of getting it right
A webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will offer insights into how to prevent such actions from the FDA.
Susanne Manz, who is an accomplished leader in the medical device industry emphasizing on quality, compliance, and Six Sigma, will be the speaker at this. To enroll for this webinar, just log on to http://www.compliance4all.com/control/w_product/~product_id=501045
Management responsibility has a new meaning
The role of important personnel in the medical device company, such as Quality leaders, general managers, and executives includes “Management Responsibility”. The scope of the responsibility includes:
o Quality Policy
o Management Review
o Quality Planning
o Quality System Procedures
Important from all standpoints
Why is it absolutely necessary to get Management Responsibility right? It is because the FDA expects a company’s compliance, its business depends on it, and customers demand safe and effective medical devices.
Susanne will set participants on the correct path to establishing an effective and efficient Quality System. All that matters to accomplish this, such as an understanding of the regulations, what medical device company executives need to learn in every management review, key questions and checklists, and what companies need to do, will all be explored at this webinar. Susanne will show how medical device companies can create a culture of quality and lead by example.
She will cover the following areas at this session:
o Basics of the Quality System Regulation (QSR) requirements
o What “Management Responsibility” means to the FDA
o Park Doctrine and FDCA (Food, Drug, and Cosmetic Act) Violations
o The Ten Commandments for creating a culture of quality in your organization
o How to use management review to ensure you have a suitable quality system
o Case studies and examples
o Risk-based decision making
o Creating quality plans and strategies.