Tort Law and Strict Liability for FDA Regulated products-What every Regulatory Affairs and Quality Professionals should know

Confusing and confounding principles of law will be clearly presented. Ample references to easy to read and understand supplemental information relating to the topic will be identified. Knowledge is power. Sign up to participate in this important webinar. It may be the most valuable and practical webinar you participate in this year.

What Attendees will Learn:

• The essential aspects of Tort Law, the legal basis for product liability claims and their relationship to regulatory and quality compliance
• Gain a understand the law to enhance your persuasive authority within your company
• The current legal theory that is applicable to biopharmaceutical and medical device manufacturers?
• The most common flaws or weaknesses in manufacturers’ product development programs that increase the risk of liability suits?
• Practical and immediate steps to take to dramatically reduce your risk of product liability exposure
• Long-term strategies to ensure an efficient product development program while also minimizing tort liability risks
• Strategic and tactical steps to make your life easier and more productive with regards to legal and regulatory compliance

The Webinar will generally valuable to any person working in Regulatory Affairs or Quality Systems, however it will be most beneficial to those professionals in decision-making positions with responsibility for day-to-day activities and oversight of product development teams.

This include:

• Regulatory Affairs professionals
• Quality Assurance professionals
• Middle to senior management of Engineering / Product Development
• In-house counsel seeking to better understand the nexus between product development/design controls and tort liability
• Consultants

Instructor Profile:

Robert J Michalik Esq., RAC, is a licensed attorney in Massachusetts and founder of RegulatoryPro.com, a consulting firm providing general and specialized services to the biopharmaceutical and medical device industries. Mr. Michalik has over 20 years experience working in the biopharmaceutical and medical device industries. Starting with a bachelor’s degree in science (biochemistry), Bob has held a wide variety of technical, quality and regulatory positions that literally span the scope of new product development and commercialization activities. In addition to his legal and regulatory practice, Mr. Michalik is also a faculty member at Northeastern University in Boston, MA where he teaches graduate-level coursework in the areas of FDA law and regulation within the Masters Degree in Regulatory Affairs program

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