Quali-Tea with Anne

In this episode I am joined by the CellCarta regulatory team to discuss the IVDR implementation and impact on clinical trials. The In Vitro Diagnostic Regulation (IVDR) replaced the IVDD and entered into force on 26 May 2017 with 26 May 2022 as date of application.

In this episode we discuss the current challenges of supply chain managment, how to adapt and mitigate risks.

In this episode I am joined by Steven Keizer, Bethan Rider, Kim Melvin and Carol Keizer to talk about what we expect to see come out as the top trends in the world of quality in 2023.

In this episode we talk about KPI’s and quality objectives, how to build metrics that are meaningful and effective to improving the quality system.

In this episode Kim Melvin and Steven Keizer are back, this time to share their wisdom and experience on training in a GMP environment. We discuss the challenges and tips to both build a new program as well as maintain an effective program that keeps employees engaged.

In this episode I am joined by Walter Wardrop in a discussion on change management and transformation. Walter provides insightful comments on how to initiate, bring people along and effectively transform an organization through change.

The dreaded annual quality training…listen to find out how to keep it current, engaging and fun. In this episode we dive into the challenges and provide practical tips for keeping cGMP training and procedures current. The concepts can be applied to any cGXP quality system.

In this Episode we discuss the topic of remote/virtual audits. Virtual audits are now commonplace in regulated industries as the pandemic forced both customers and regulators to audit differently. Today we cover the benefits and challenges of this audit format.

A group of Quality professionals chat about how to build a positive quality culture in any organization.