Combination Products: Clinical Benefits, Regulatory Issues & Manufacturing Challenges

Unfortunately, we have had to postpone this course.  We are working with the instructor to schedule a new date.  If you would like to be informed of the new date – and receive a coupon code for 20% off – please email info@lifesciencetraininginstitute.com.  We apologize for the inconvenience.

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Date: April 11, 2016
Time: RECORDED SESSION
Duration: 90 Minutes - Online, each day
Price: $549 - Includes job-aids and reference materials!
A comprehensive two-part training series
Dates: April 11 (Part I) and April 29 (Part II), 2016
 
Course Description:

Combination products offer an attractive solution to some complex therapeutic problems.  Additionally, they offer the promise of a sustainable business model as an estimated 30% of all new healthcare products under development today are combination products.  However, the challenges of navigating the regulatory approval process and manufacturing these often complex products can present a barrier to market that is often difficult to overcome.  Furthermore, confusion surrounding regulatory governance of novel combination products leaves many prospective manufacturers asking the question “where do I start?”

This course will provide you with the foundational understanding to effectively navigate the regulatory process while safely and efficiently manufacturing high-quality combination products.  Additionally, you will gain an understanding of the roles of regulatory bodies in the US, plus receive a glimpse into the future of combination products and opportunities on the horizon. 

By attending this two-part, interactive online course, you will learn the following:

Part I (April 11, 2016):

  • Reviewing combination product determination including a brief understanding of requests for designation (RFD)
  • How combination products are currently regulated – Tips and tricks to use current pathways to your advantage.
  • The top regulatory pitfalls to avoid, and tips to get your products on the right track to approval and the manufacturing stage.

Part II (April 29, 2016):

  • What are the manufacturing challenges of combination products, i.e., sterility, stability, shelf-life, packaging, etc.?
  • Combo product quality management systems

Geared for both experienced medical device professionals as well as those new to the industry, this course is designed for those who need a better understanding of the current regulatory requirements surrounding combination products.  This unique seminar demonstrates important regulatory requirements and concepts using case study discussions of real products from a variety of clinical specialities.  Scientists, engineers and technicians working on device design and development, product and product development managers, business development managers, marketing managers, QA/QC personnel, regulatory affairs professionals, investment and acquisition specialists, and field service engineers will all benefit from this webinar.

David Amor, MSBE, CQA is a medtech/biotech consultant and mobile health entrepreneur who founded Medgineering, a company focused on remote compliance, regulatory & quality systems consulting for larger companies and start-ups alike. A graduate of the prestigious Innovation Fellows program at the University of Minnesota’s Medical Device Center, David was named a Top 40 Under 40 Medical Device Innovator in 2012 and a 35 Under 35 Entrepreneur in 2015 by MN Biz Magazine. Recently, David co-founded and helped launch Remind Technologies, a Texas based mobile health company developing smartphone based remote medication management system (www.remind-technologies.com).  He also is co-inventor on several issued utility patents and co-pioneered a disruptive e-consulting platform for the medtech and pharma industries called QuickConsult (www.myquickconsult.com). Lastly, David also serves as an adjunct professor at St. Cloud State University in Maple Grove, MN where he teaches courses on risk management and design control. The current focal points of his consulting practice are specializing in risk management, design controls, combination products and mHealth.