FDAnews Announces: Combination Products — Industry Challenges, Oct. 4, 2017

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Combination products have been around for years, however challenges regarding compliance continue to abound. FDAnews and NSF International have joined forces to present a hands-on workshop that takes manufacturers from compliance to new sales, with stops along the way for best GMP and quality issues.

Combination Products — Industry Challenges
**Presented by FDAnews and NSF International**
Oct. 4, 2017 ∙ Silver Spring, MD
http://www.fdanews.com/combinationproducts    

How can combination products manufacturers tackle a compliance mine field?

That’s what just about every FDA-regulated health science company wants to know before getting in any deeper. So many questions:

  •     For drugmakers, which device regs apply and when?
  •     For devicemakers, which drug regs and when?
  •     And once the primary mode of action is sorted out, what pitfalls remain as manufacturers bring new combination products to address? How do they address legacy products?

FDAnews and NSF International have joined forces to present a hands-on workshop that takes manufacturers from compliance to new sales, with stops along the way for best GMP and quality issues. Attendees will discover:

  •     Latest thinking from top FDA policymakers
  •     Learn-by-doing case studies featuring real-life tales from Janssen and Gilead
  •     A look into the crystal ball at what lies ahead for combination products
  •     And much more

Over the course of a full day of intense learning and discussion, attendees will gain knowledge and insights to help them:

  •     Interact with FDA OCP, CDRH and CDER representatives as well as industry leaders on combination products
  •     Understand how to develop integrated cGMPs and regulatory strategies for combination products
  •     Discover 10 best business practices and lessons learned from industry leaders
  •     Recognize how and when to implement 21 CFR 820 requirements for design controls, and develop strategies for remediation of legacy pharmaceutical products
  •     Understand nuances such as when container/closure becomes a combination product

And attendees will interact with top FDA officials in a relaxed and casual setting and with fellow participants as they wrestle with four interactive case studies.

Whether a manufacturer is fully committed to combination products or just getting its feet wet this workshop will deliver knowledge and contacts that is worth the time. With experts on hand from the FDA and industry, it’s a perfect learning and networking opportunity.

Who Will Benefit:

  •     Engineering managers
  •     Quality engineers
  •     Analytical chemists
  •     Training and internal audit oversight
  •     Purchasing and supply chain
  •     Procurement agents involved in outsourcing
  •     R&D staff — engineering and analytical labs
  •     Regulatory affairs/compliance

Conference Details:
Combination Products — Industry Challenges
**Presented by FDAnews and NSF International**
Oct. 4, 2017 ∙ Silver Spring, MD
http://www.fdanews.com/combinationproducts    

Tuition:
Early Bird Price (through Sept. 15): $697
Regular Price (after Sept. 15): $897

Easy Ways to Register:
Online:     http://www.fdanews.com/combinationproducts
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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