What do you need to know about the new FDA guidance on Manufacturing Site Changes?
By Deb Bartel,
Recently, the FDA drafted this guidance document to help the medical device industry make decisions around manufacturing site changes. This guidance is intended to help in managing the time frames for changes in manufacturing sites and the associate changes to processes, methods, procedures, qualifications and validations by helping industry predict when an FDA pre-approval inspection is likely to be required for … Read more
