Quali-Tea with Anne

In this conversation, Anne and Daniel Charles from Compliance Insight discuss the three types of FDA 510k submissions: traditional, special, and abbreviated. They explore the requirements, benefits, and trends associated with each submission type, emphasizing the importance of understanding the 510k process for medical device manufacturers. Daniel shares insights on the review process, common issues faced during submissions, and tips for ensuring a successful review.

In this conversation, Anne and Michael Neece discuss the intricacies of handling difficult conversations, particularly in leadership and quality management contexts. They emphasize the importance of approaching these conversations with kindness, creating a safe environment, and being mindful of timing. Various feedback mechanisms are explored, including the sandwich principle and alternative methods that encourage self-reflection. The discussion also highlights the significance of self-forgiveness and maintaining a focus on the ultimate goal of quality assurance in patient care.

In this conversation, Anne and Dia Hill discuss the FDA's final rule on laboratory developed tests (LDTs), focusing on the implications for the industry, the shift in regulation, and the challenges laboratories face in compliance. They explore the phased implementation timeline, the need for training and resources, and the importance of regulatory assessments and classification of tests. The conversation highlights the global implications of these regulations and the necessity for laboratories to adapt to new quality systems and oversight requirements.

In this conversation, Anne and Melissa discuss the modernization of cosmetic regulation, specifically the Modernization of Cosmetics Regulation Act (MoCRA) of 2022. They cover the scope of the act, which includes all personal care items, and the increased responsibility it places on cosmetic companies. They also discuss the history of cosmetic regulation, the motivation behind the modernization, and the specific sections of the act that have already been implemented. Melissa highlights the challenges faced by companies, such as registration, adverse event reporting, safety substantiation, and mandatory recall. They also touch on the upcoming release of the good manufacturing practice (GMP) guidelines and the need for companies to prepare for inspections. Overall, the conversation provides an overview of the key changes and requirements brought about by the modernization of cosmetic regulation.

In this conversation, Anne, Bethan, Kim, and Carol discuss the qualities and interview questions to consider when hiring for positions in quality. They highlight the importance of communication skills, interpersonal awareness, technical writing skills, and experience in quality. They also emphasize the need for collaboration, a risk-based mindset, and the ability to make decisive decisions. The conversation explores different interview styles, including situational questions, presentations, and written assessments. They also discuss the significance of follow-up emails and attention to detail in the interview process.

Michael Neese, president of Our Future is Kind, discusses the importance of kindness in building a good quality culture. He emphasizes the role of emotional stakes in driving people's behavior and the need for leaders to be tuned into the invisible forces underlying interactions. Neese explains that kindness is not just a warm and fuzzy concept, but a critical part of business that can boost productivity, innovation, and psychological safety within teams. He suggests practical tips for leaders, such as asking for feedback and creating a culture of collaboration, as well as tips for individuals to bring kindness into their organizations.

In this conversation, the hosts discuss the qualifications and process of becoming an auditor. They share their own experiences and highlight the importance of practical training, mentorship, and formal certifications. They also discuss the documentation of auditor qualifications and the need for ongoing education and staying current with regulations. The conversation concludes with the benefits of being a qualified auditor and the opportunities for learning and growth in this role.

In this episode, part two in the series on auditing. The hosts discuss the best way to close out an audit.

In this conversation, Anne, Kim, and Steven discuss where to start when conducting an audit. They suggest asking for a list of deviations, change controls, and out-of-specifications (OOS) results before going on the tour. They also recommend requesting these lists in an Excel format for easier searching. Other starting points include reviewing batch records, the site validation master plan, the quality manual or site master plan, and the standard operating procedure (SOP) list. They also emphasize the importance of looking at annual product reviews, overdue calibrations and preventive maintenance, and data integrity in computer systems. Additionally, they discuss the value of walking through batch records and processes, checking management reviews and trending, and paying attention to pest control and warehouse areas.

In this Q&A session, Anne answers questions about getting people on board with the value of quality incidents, handling a refusal to document changes, and managing audits efficiently. She suggests visually demonstrating the value of investigations and quantifying the cost of quality incidents to gain support. For documenting changes, she recommends simplifying the process, having change champions, and ensuring timely documentation. To manage audits effectively, Anne advises implementing an audit readiness program, preparing pre-prepared reports, and having subject matter experts ready.

The conversation explores work-life balance for quality professionals and provides tips for managing it. The speakers discuss the importance of scheduling breaks, setting boundaries, and prioritizing tasks. They also emphasize the need for flexibility in quality roles due to unexpected events and global work. The conversation touches on the challenges of technology and the availability of work at all times. The speakers suggest having a support system and recognizing burnout. They also highlight the importance of taking vacations and fully disconnecting from work.

The BIO International Convention covered a wide range of topics and trends in the biotech industry. Some of the key themes discussed include the growth of companies in the development and early phases of drug development, the importance of data integrity and documentation for regulatory compliance, the use of virtual reality and AI in training and drug development, and the advancements in diagnostic testing and disease treatment. The conversation also touched on the challenges of validating AI and the need for caution in relying blindly on AI decisions. Overall, the convention showcased the evolving nature of the industry and the exciting possibilities for the future.

The Day 3 Daily Update covers a range of topics from the Bio International Convention, including speaker talks, trends, regulatory insights, social events, and booth experiences. Melissa shares insights on the activities, trends, and interactions at the convention, providing valuable information on the industry's current landscape.

Troy Fugate discusses the Bio International Convention, focusing on compliance, quality, and industry trends. He emphasizes the importance of planning, procedures, and leadership in compliance, as well as the value of quality and regulatory teams for startups and biotech companies. Troy also highlights the presence of various countries and the interest of investors in the industry.

This week we have a special series of Daily Updates with the Compliance Insight consulting team live at the BIO International Convention in San Diego. In this daily update with Melissa Schneider, she provides insights into the Bio International Convention, highlighting the focus on the biologics space, the presence of contract manufacturing organizations, and the efforts of states and countries to attract biologic companies. Melissa also discusses the trends, needs, and insights into biologics.

In this conversation, Anne and Kim discuss the process of material qualification, covering topics such as the steps to take, considerations for new materials, challenges, and documentation requirements. They also touch on the importance of risk assessment and the impact of supplier qualification on material certification.

Takeaways

In this conversation, Anne MacNeil and Walter Wardrop discuss the leadership role in transformation and the importance of adequate resources. They highlight the key areas that leaders should focus on during a large transformation, such as understanding the change and its importance to the business. They emphasize the need for leaders to be inspirational and passionate about the change to build buy-in from the team. They also discuss the role of a sponsor in clearing the road and having the team's back. The conversation touches on the importance of resource allocation and engaging team members by helping them understand their value and contribution to the project. They also mention the need for fresh ideas and thinking outside the box to find innovative solutions. Overall, the conversation provides insights into effective leadership and resource management during transformation projects.

Takeaways

In this conversation, Anne and Kim discuss the different areas of supplier oversight, including supplier qualification, risk management, and continuous evaluation. They emphasize the importance of involving quality from the beginning in the vendor selection process and highlight the role of risk assessment in determining the level of qualification needed. They also discuss the next steps after selecting a vendor, such as performing an on-site audit and establishing a quality agreement. Continuous monitoring and documentation of supplier qualifications are also emphasized.

In this first conversation of a two part series, Anne MacNeil and Walter Wardrop discuss the difference between process change and culture change. They emphasize the importance of defining the problem and understanding the root cause before implementing any changes. They also highlight the need to consider the people element and engage stakeholders early on to ensure buy-in and ownership of the change. Walter shares insights on the influence model and the importance of role modeling, fostering understanding and conviction, reinforcing change through formal mechanisms, and developing talent and skills. They also discuss practical tools and tips for facilitating change, including selecting the right approach, defining the desired outcome, and timing the workshops effectively.

"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.

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.

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, justification, approval, and implementation. They discuss the role of a change control committee and the importance of having an owner for each change. The conversation concludes with a discussion on the documentation and implementation of change controls.

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 subject matter experts (SMEs) for the inspection. They also discuss the value of mock inspections and the effectiveness of inspection readiness training. The panel concludes by highlighting the importance of being truthful and avoiding arguments with inspectors, as well as the significance of referring to procedures during an inspection.

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 regulated and non-regulated industries is discussed, with an emphasis on the core focus of public health and safety in regulated environments. The value of basic procedures, such as addressing customer complaints within a specific timeframe, is recognized. The conversation explored the challenges and benefits of transitioning from a quality role to a non-quality role. It highlighted the importance of defining quality and having a quality policy in place. The discussion also touched on the need for creativity and innovation in non-quality roles and the potential conflict between a risk-averse mindset and a more creative approach. The importance of understanding the customer and continuously learning and growing was emphasized. Overall, the conversation encouraged individuals to take the leap and explore different roles within their industry.

Takeaways

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. The hosts emphasize the importance of women in leadership roles for driving change and advocating for patients. They also discuss the challenges faced by women in the industry, including the impact of child-rearing and caregiving responsibilities. The conversation concludes with a positive outlook for the future and the importance of mentors and role models in supporting women's career development.

Takeaways

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 options. The conversation highlights the importance of communication, trust, and security measures in remote work. Overall, the episode emphasizes the need for flexibility and adaptability in managing remote teams.

Takeaways

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 and gene therapy products. The conversation covers topics such as stability studies, retained samples, and the challenges of distribution and transportation. The episode concludes with a discussion on the market size and impact of cell and gene therapy, as well as the skills and education required for individuals interested in this field.

Takeaways

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 challenges of changing established processes and the need for specialized expertise in training. We suggest incorporating best learning practices and considering different learning styles. The episode concludes with tips for building effective training programs.

Takeaways

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 about to embark on such a project.

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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 dedicated to the advancement of the pharmaceutical industry through the training and development of its members. To learn more check out: https://psg.ca/

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.

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