It’s possible to learn from failures resulting in unacceptable risks for combination drug-device-biologic products what design input requirements are essential to the safe and effective operation and use of such products, Susan Neadle, head of combination products at Johnson & Johnson, said at the World Drug Safety Congress Americas.
To View This Article:
Subscribe To The GMP Letter
The GMP Letter Subscription
The GMP Letter (GMP) to stay on top of the FDA's interpretation and enforcement of the quality systems regulation and to learn which changes they must make to stay in compliance. In each monthly issue, you get an update on key regulatory developments, tips on how to prepare for FDA inspections, proven ways to improve design control procedures, ideas to create more effective GMP training programs and more.
With a subscription to The GMP Letter, you’ll get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.
Each issue provides:
New and draft FDA guidances;
Implications of new regulations
Reasons/causes for the most recent warning letters;
Updates on key regulatory developments;
Tips to prepare for FDA inspections;
Proven ways to improve design control procedures; and
Ideas to create more effective GMP training programs.
There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with The GMP Letter, you may cancel your subscription and receive a full refund. No questions asked.
So, why wait? Become a subscriber to The GMP Letter today. It couldn’t be easier.