In this episode I am joined by Kim Melvin, and Carol and Steven Keizer in this insightful talk on technology transfers, transferring and validating a method and all the tips, tricks and risks in between. Between this crew there is a wealth of practical experience in executing technology and method transfers and method validations and we hope this gives you an idea of what to consider if you are about to embark on such a project. We are loving Riverside FM, check it out here and use my affiliate link if you want to try it out: https://www.riverside.fm/?utm_campaign=campaign_5&utm_medium=affiliate&utm_source=rewardful&via=anne-macneil
In this episode we review some of the updates to the ICH Q9 guideline that was released in Jan 2023 and discuss trends we are seeing since release in risk management. For more information visit: https://ich.org/page/quality-guidelines and select Q9 to read the full guideline and access the training materials.
It's time for our annual predictions for the world of quality in 2024.
In this episode I am joined by Kim Melvin, Steven Keizer, and Carol Keizer for a light hearted discussion on returning to work after the holidays or an extended vacation. We provide our best tips for planning, easing back in to the routine and how to tackle that inbox and list of to-do's after some time away from the desk.
In this episode Kim Melvin and Steven Keizer join me for a fun discussion on how we can share regulatory updates, investigation trends and other information pertinent to improving quality systems within and across organizations.
The use of gamification in training is gaining popularity and is a great way to add engagement and retention to your quality management system’s training program.
In this episode we discuss how to create a good CAPA, complete it and ensure it is effective. Investigations are always a challenge and it’s not over after the root cause is established, an effective CAPA will ensure the issue does not reoccur.
At some point we all need to either implement an electronic quality management for the first time or change/upgrade our existing system. In this episode we cover some of the important things to consider when choosing the right eQMS for your organization and best practices for implementing and launching the system.
In this episode I am joined by Jay Chopra from The Making Shift Happen Podcast: https://podcasts.apple.com/us/podcast/making-shift-happen-podcast/id1579559383. We discuss how everyone can be a leader. When you work as a quality professional you know you are often called on to be a leader even when you may not manage people or have direct reports. Visit Jay’s podcast for more great tips on making work more human.
In this episode I am joined by Steven Keizer and Bethan Rider for some quick tips on how to conduct a thorough investigation, best questions to ask and how to get to the root cause.
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 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.
"What is an acceptable level of quality?" In this conversation, Anne and Troy discuss the concept of acceptable quality level (AQL) and the importance of defining and understanding it. They highlight the need to consider the specific product and its intended use when determining the level of quality control. They also discuss the potential pitfalls of having too little or too much quality control, as well as the importance of having a clear vision and rationale for the AQL. The conversation also touches on the role of leadership in defining and supporting quality, as well as the impact of AQL on patients and costs.
In this episode, Anne and Kim discuss regulatory processes and submissions. They provide an overview of the CMC (Chemistry, Manufacturing, and Controls) template used in regulatory submissions. They also discuss the differences between brand new submissions and changes to existing submissions. The process of submitting changes for review and approval is explained, including the different types of changes and the expected timelines. Tips for successful submissions are shared, emphasizing the importance of providing the right level of information without overwhelming the submission. The episode concludes with an invitation for listeners to suggest specific topics or countries for future discussions.