Search Trainings

90 results of "Life Sciences x" and "Biotech & Biologics x"
Live Webinar

How to get a 510(k) for a Machine Learning Product

We will explain what a 510(k) is and explain the other FDA regulatory pathways. We will discuss how software can be considered a device by the FDA.  The procedure to obtain a 510(k) will be explained.  The contents of the submission to the FDA will be explain ...

Live Webinar

Medical Device Software Validation Meeting FDA Regulations

This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are us ...

Live Webinar

Current GXP expectations on Water system validation compliance

The most crucial factor to achieve Business Growth in Pharma manufacturing nowadays, is Compliance with GMP norms, so as to increase the technical and financial strength of Manufacturing units. Currently, the aspect focused on by most Auditors, both internal, ...

Live Webinar

Biomarkers in Drug Discovery and Development

Biomarkers are a key medical product development tool capable of facilitating the development of medical products and spurring innovation. When used in the right context, biomarkers have the potential to help expedite patient access to safe and effective treat ...

Live Webinar

Investigating OOS results

This webinar will review the regulatory requirements for investigating an OOS Investigation.   The responsibilities of the analyst, the supervisor, and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the step ...

Live Webinar

Human Error Solutions: How We Reduced 60% Of Human Errors In Less Than A Year, A Case Study

Pharmaceutical manufacturing sites continuously compete, even within the same company to maintain production volumes and avoid closures. To attain the status of high-performing organization manufacturing sites are implementing strategies and practices like ope ...

Live Webinar

The Importance of Packaging and Labeling in Pharmaceutical Product Development

Occupying a critical position in the success or failure of any pharmaceutical product launch or revision, Packaging and Labeling form a bridge between the conception of a product and its realization and distribution. Their activities are also crucial for compl ...

Live Webinar

Extractables & Leacheables in Drug Development

An effective extractable and leachable evaluation is essential for the overall success of any pharmaceutical drug development program for both small molecules and biological agents. In this webinar expert speaker, Stefano Persiani will focus on the basics of a ...

Live Webinar

Training Effectiveness: How to develop instruments to measure learning and reduce errors

Training programs have evolved through time. Human reliability or human error is usually attributed to training effectiveness or training program weaknesses/strengths. Even though Training is considered the “vaccine for mistakes,” Training is as good as its ef ...

Recorded Webinar

An Advanced Course on Lean Documents, Lean Configuration, and Document Control

In this Lean Documents, Lean Configuration, and Document Control training learn the different types of lean documents and the usage of lean document principles; types of controlled documents; examples of lean and non-lean controlled documents. Pros and cons of ...