Quali-Tea with Anne

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 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 MacNeil interviews John Fraser to explore the critical intersection of quality assurance, engineering, and regulatory compliance in the medical device industry. Discover insights on how quality is integrated from R&D to commercialization, the challenges of software regulation, and the evolving role of quality engineers in medtech.**Key topics:**- The role of quality in early product development and design controls- Differences between R&D and engineering in medical device development- When to implement design controls: timing and considerations- Unique challenges of software as a medical device (SaMD), including cybersecurity and rapid iteration- How regulatory frameworks like ISO 14971 inform risk assessments- Collaboration gaps between quality, regulatory, and engineering teams- The importance of building quality into organizational culture from the start- Future trends and the growing need for dedicated roles at the intersection of compliance and engineering**Timestamps:**00:00 - Introduction to quality in medtech R&D and the importance of early integration 02:28 - Balancing compliance with innovation in product development 03:18 - Differences between R&D and engineering roles across industries 04:12 - When to start applying design controls in medical device projects 05:23 - Risks and timelines involved in iterative development, especially for IVDs and software 06:53 - Classification of high-risk versus low-risk devices and early controls 08:12 - The value of designing quality processes early and avoiding rework 09:39 - How engineers follow standards without realizing they meet regulatory requirements 11:47 - Challenges specific to software development in medical devices 13:15 - Unique considerations for cybersecurity and data privacy 15:12 - The intersection of quality management, cybersecurity, and regulatory oversight 16:23 - Responsibility sharing between quality systems and cybersecurity frameworks 18:47 - Overlapping risk assessments for safety and security risks 20:33 - How regulatory bodies evaluate security and data privacy in submissions 22:14 - Navigating the organizational landscape: roles, silos, and collaboration gaps 23:43 - Building and integrating a systems engineering approach in medtech 26:00 - Nuanced regulatory requirements for device safety versus usability and risk 28:23 - Practical risk management strategies over over-engineering solutions 28:52 - How harm is defined in ISO 14971 and its application to cybersecurity risks 29:47 - The evolving career landscape: growth areas at the intersection of compliance and engineering **Resources & Links:**- [ISO 14971 Risk Management Standard](https://www.iso.org/standard/72853.html)- [ISO 13485 Medical Devices Quality Management Systems](https://www.iso.org/standard/59752.html)- [ISO 27001 Information Security Management](https://www.iso.org/isoiec-27001-information-security.html)- [Design Controls in Medical Devices (FDA Guidance)](https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/design-controls)- [Cybersecurity in Medical Devices](https://www.fda.gov/medical-devices/cybersecurity-medical-devices)- [EU Accessibility Act](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32021L0525)---*This episode offers valuable insights for professionals navigating compliance, engineering, and quality assurance in the evolving field of medical technology. Whether you're in software, hardware, or integrated devices, understanding how to embed quality from the ground up is key to successful product launches and regulatory approval.*

SummaryThe conversation explores the significance of gratitude in corporate settings, highlighting the disparity between the desire to express gratitude and the actual execution of it. It delves into whether gratitude serves as a form of recognition or as a motivational tool for employees.