Life Sciences Webinars

• 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...

By Internal Team

• 60 Mins

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...

By Internal Team

• 60 Mins

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...

By Internal Team

• 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

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