Combination products remain a compliance challenge for drug and device makers, diagnostics and biotech firms. The cross-industry nature of the combo products raises regulatory issues, manufacturing and marketing challenges.
Don’t be put off by the challenges. Help is at hand.
Come to Washington in October for a standout workshop presented by FDAnews and NSF International. Over a full day of interactive learning-by-doing, you’ll gain understanding of the new regulatory landscape, and insights into marketing and merchandising challenges. Be prepared to:
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 products
Understand nuances such as when container/closure becomes a combination product
And you’ll interact with top FDA officials in a relaxed and casual setting, and with fellow participants as you wrestle with four interactive case studies. There’ll be breaks for lunch and refreshments, and afterward the opportunity to recharge at a cozy lounge or restaurant and take advantage of the additional time to strategize and network.
It’s well worth carving a day out of your busy schedule to attend this standout session in person. Networking opportunities alone justify the trip to Washington.
Combination products present unique regulatory, manufacturing and marketing challenges. Get the knowledge and the tools you need, and network with the movers and shakers who can help you attain your goals. Register now.