Certain types of deviations require reporting to the Health Authority in the country where the product is marketed. We will focus on two major Health Authorities: US and Europe. Review the requirements for reporting deviations for biologics products for FDA (called a Biological Product Deviation) and for EMA (called a Quality Defect Notice). On each of the websites provided, you will find additional hyperlinks for the reporting template and also the process for reporting deviations for each Health Authority. Compare the reporting templates and processes for EMA and FDA and summarize what is similar and what is different between the two. Items to consider include: what information must be reported? What type of deviations must be reported? How soon after discovery must the deviation be reported? etc., etc