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

Instructor: Bob Michalik, JD, RAC Michalik
Product ID: 700216
Training Level: Intermediate to Advanced
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Apr-2007

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

Essential elements of tort law, product liability and defensive strategies to protect your company


In this Training, essential elements of tort law, product liability and defensive strategies to protect your company will be outlined in detail.

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
Who Will Benefit

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, 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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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

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Product Reviews Write review

Excellent content and overview of Tort law.
- Anonymous

I really liked this seminar. The presenter was very good and kept the subject interesting. I would recommend him.
- Anonymous

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