Pharmaceutical Webinars

• 60 Mins

In the last year/recent months, there have been a lot of changes in the pharmacovigilance requirements especially impacting the reporting to EudraVigilance, the Signal Detection Management (e.g. inclusion...

By Internal Team

• 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

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

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

The EU Medical Device Regulation (MDR 745/2017) represents a considerable change from the directives it is replacing. Device manufacturers who conduct business in the EU must start their transition now in...

By Internal Team

• 60 Mins

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...

By Internal Team

• 60 Mins

Some regulatory guidelines mention the need of a QMS. But every company should have a library for its biggest asset – the knowledge of the employees. The reason to have a QMS is not to satisfy the regulat...

By Internal Team

• 60 Mins

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...

By Internal Team