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60 Mins
This program will address approaches to regulatory affairs project management for clinical trial applications, marketing authorization applications, and ongoing management of regulatory obligations. The i...
Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer...
Experimentation is frequently performed using trial and error approaches which are extremely inefficient and rarely lead to optimal solutions. Furthermore, when it’s desired to understand the effect of mu...
Agreeing to an FDA foreign inspection requires careful preparation on a firm’s part. If you do not manage your inspection wisely, you will set yourself up for disaster. We will cover fundamental issues, s...
Overview of FDA FSMA (Food Safety Modernization Act), a rule which became effective in September 2016 for the food industry. The new regulations have shifted from a reactive FDA focused primarily on GMP’s...
Allergens are now a Class I Recall by the FDA (Food & Drug Administration), considered an adulterant in foods. It is the largest area for recalls in the US and growing at a staggering rate. Anyone wanting...
The webinar will leave you with the information needed to create and maintain good documentation that meets FDA compliance standards. You will learn about what must be done and what must not be done. In a...
California’s Prop 65 enacted to inform its’ residents and workers the hazards associated chemicals and toxins that may cause harm has ballooned to over 900+ items, that industries must be aware of to oper...
The new standards will be covered in this session encapsulating everything industry needs to know on launching the SFCR.Understanding SFCR and HistoryLicensingPreventative ControlsImportingExportingPortal...