All FDA Regulated Industry Webinars

• 60 Mins

Inadequate investigation of out-of-specification (OOS) results in the laboratory is a common observation cited in FDA 483s and Warning Letters. It is clear that regulatory investigators throughout the wor...

By Internal Team

• 60 Mins

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...

By Internal Team

• 60 Mins

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...

By Internal Team

• 60 Mins

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...

By Internal Team

• 60 Mins

The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training, and experience to complete their job functions. Onb...

By MICHAEL ESPOSITO

• 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...

By Internal Team

• 60 Mins

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...

By Internal Team

• 60 Mins

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...

By DAN SCUNGIO

• 60 Mins

The new standards will be covered in this session encapsulating everything industry needs to know on launching the SFCR.Understanding SFCR and HistoryLicensingPreventative ControlsImportingExportingPortal...

By Internal Team