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60 Mins
This webinar is designed to help pharma companies through the various key aspects of the Chemistry Manufacturing and Controls (CMC) information expected by FDA in an IND (Investigational New Drug) Applica...
This webinar will highlight difficulties in obtaining relevant and useful dissolution results based on current practices. This will be followed by the description of principles of drug dissolution testing...
Do you know why OSHA would come to your lab? Do you know how to respond to an OSHA complaint or allegation? Join Dan the Lab safety Man as he discusses the steps to prepare your lab for an OSHA visit and...
This course is essential for Medical Device companies interested in submitting software enabled medical Devices or Software as a Medical Device to the FDA for 510K approval. One of the biggest risks most...
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 hazardous waste rules including the generator standards have been in existence since 1980. In 2016, EPA recently revised the standards with the intent of simplifying the generator rules. This training...
The various regulatory agencies have expectations that pharmaceutical manufacturers will demonstrate control over their manufacturing processes, validations, and documentation. Quality auditing is the pro...
The new standards will be covered in this session encapsulating everything industry needs to know on launching the SFCR.Understanding SFCR and HistoryLicensingPreventative ControlsImportingExportingPortal...