Miss.Danielle Delucy

Process of following the procedures and processes that are agreed on during a selection audit process. It identifies nonconformances in the manufacturing process, engineering change process, invoicing process, quality process, and also the supplier/shipment pr ...

In sterile compounding, the aseptic technique contributes to the prevention of microbiological contamination.  It provides sterility, safety, and efficacy to the sterile product, especially various injections for patients. Cleaning, Gowning, and proper methods ...

In this webinar attendees will learn the fundamentals for reviewing batch records in a pharmaceuticals, biologics, and medical devices environment. You will hear about the proper training that must be demonstrated before one is considered a suitable reviewer o ...

In order to solve problems, every organization must know how to conduct an effective investigation, identify root causes, and implement workable corrective action in a timely manner. An effective CAPA process requires training internal investigators, who can a ...

Deviation investigations are a very common topic to be reviewed during FDA investigations. Ensuring the firm has robust and complete write-ups of these situations is key to a successful audit. Having inadequate investigations could potentially cause some sever ...

This webinar will help attendees understand the fundamental change control steps and processes. It will focus on change proposals, assessments, execution, and final implementation. The importance of proper planning, critical thinking skills, and coordination o ...

The purpose of the Regulatory inspection is an activity that should demonstrate that your company is operating according to the proper CFR requirements and maintaining a state of compliance. The key to a successful audit is being able to communicate how your q ...

This webinar will give a brief overview of the general procedure for the preparation and documentation of the Annual Product Quality Review and also focuses on the regulations and the regulatory requirements as per US and Europe. Annual Product Quality Review ...

In order to solve problems, every organization must know how to conduct an effective investigation, identify root causes, and implement workable corrective action in a timely manner. An effective CAPA process requires training internal investigators, who can a ...

In many companies, deviation/non-conformance investigations are often criticized for the lack of a robust root cause analysis. Proper root cause can help a company in many ways. Root cause analysis helps identify what, how and why something happened, thus prev ...