Quali-Tea with Anne

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, a...

In this conversation, Anne, Kim, and Stephen discuss how to build a simple change management process. They emphasize the importance of keeping the process compliant but easy to follow. They also highlight the need for impact assessments, risk assessments, and well-documented justifications for changes. The conversation touches on the minimum requirements for a change control, including statement,...

In this episode, the panel discusses how to train individuals to behave in a regulatory inspection. They emphasize the importance of thinking before speaking and the consequences of saying the wrong thing. The power of silence and how to handle it during an inspection is also discussed. The panel shares tips on training individuals to handle silence and the importance of selecting the right subjec...

The conversation highlights the transferable skills and mindset that quality professionals can bring to other roles and industries. Quality management systems provide a structured approach to problem-solving and can be applied to any job or industry. The importance of having guidelines, rules, and regulations in place is emphasized, as they provide clarity and peace of mind. The difference between...

In this podcast episode for International Women's Day, the hosts discuss the role of women in the pharmaceutical industry, particularly in leadership positions. They highlight the gender gap at executive and CEO levels and the need for increased representation of women. The conversation explores the positive aspects of having female leaders, such as different perspectives and leadership styles...

In this episode, Anne and San discuss the challenges and benefits of managing remote teams. They explore the dynamics of managing teams with both remote and in-office members, as well as fully remote teams. They share tips for engaging remote team members and maintaining company culture in a remote work environment. They also discuss the trend towards remote work and the preference for hybrid work...

In this episode, Anne, Carol, and Steve Keizer discuss the differences between cell and gene therapy and traditional drug manufacturing. They explore the challenges and unique aspects of cell and gene therapy manufacturing, including the need for aseptic manufacturing, patient-specific treatments, and single-unit manufacturing. They also discuss the differences in regulations and audits for cell a...

In this episode, Troy Fugate joins us to discuss the importance of training programs in the FDA's focus on quality. We highlight the need for understanding the 'why' behind tasks and the importance of competency-based training. The conversation emphasizes the continuous improvement and maintenance of training, as well as the role of coaching and mentoring. The guests also discuss the c...

This week Steven Keizer shares his insight into how digitization, digitalization and digital transformation are changing the way we look at quality.

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 ab...

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.

This week Amanda Wright, the executive director of the Pharmaceutical Sciences Group (PSG) joined us for a discussion on networking and shared some of what the PSG does to support new and experienced professionals in their career growth. The PSG is a Canadian non-profit organization based in Markham Ontario. As a neutral platform serving pharmaceutical professionals since 1971, the PSG is dedicate...

In this quick podcast snippet I provide my top five tips for reducing a deviation backlog.

In this episode I am joined by Steven Keizer, Carol Keizer and Troy Fugate who is the VP of Compliance Insight. Troy brings a wealth of experience in the quality and compliance space and shares some insightful tips on how to write a good procedure that can actually be followed.

In this episode I am joined by Heather Hanson, a two time certified Salesforce administrator to learn what is Salesforce AppExchange, what to look out for from a quality standpoint and how the use of pre built add on applications can benefit an organization. We touch on the importance of understanding the business case as well as configuration and change management.

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.

In this episode I am joined by Steven Keizer for a quick introduction to Cell and Gene Therapy including the challenges of expanding the use of this type of therapy.

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 w...

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.