When the FDA clarified its guidance on process validation for drugmakers, medical device companies were left in the dark. The CDRH did not sign on to a new guidance, leaving in place only the old and confusing guidance that dates back years.
But time hasn’t stood still on the manufacturing floor: New and more complex manufacturing processes emerge every year, greater outsourcing leaves devicemakers relying more on third-party manufacturers, and international standards continue evolving. Devicemakers need to be sure their process validation systems have kept pace with reality.
This timely document takes you step-by-step through the most complex, challenging process validation compliance problems, filling in the gaps left in the available guidance. Among questions it addresses and resolves:
You’ll discover specific solutions to issues and questions that bedevil many devicemakers. The report includes:
Lacking specific new guidance, FDA’s intentions for process validation must be identified through Warning Letters, official statements and official documents. FDAnews has done the hard work for you. Until CDRH issues its long-awaited guidance, Devicemaker’s Guide to Process Validation will keep you in compliance.
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