Claim OwnershipQuali-Tea with Anne
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© Anne MacNeil
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A place to chat about all things Quality related.
36 Episodes
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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.
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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 pros and cons of outsourcing in the quality world.
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.
In this episode, Anne, Kim, and Beth discuss data integrity and its importance in ensuring compliance. They highlight key trends, challenges, and requirements related to data integrity, including observations around quality control systems, access control, storage and backup of data, audit trails, and the process of invalidating data. They emphasize the need for periodic review of access control, justification for chosen frequencies, and the importance of defining and protecting raw data. The conversation also touches on the location of data centers, the need for investigation and justification when invalidating data, and the applicability of data integrity principles to both electronic and paper-based systems.
In this conversation, Anne, Kim, and Troy discuss the top FDA 483 observations of 2023. They cover the top observations for medical devices and pharmaceuticals, including issues with CAPA, complaint handling, supplier quality management, quality control and documentation, personnel training, and equipment and facility deficiencies. They emphasize the importance of effective procedures, training, and alignment between procedures and actual practices to address these observations. They also discuss the need for proactive measures and continuous improvement to prevent recurring issues.
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