Shows
Quali-Tea with AnneNavigating Quality System RegulationsThe conversation focuses on the importance of understanding and navigating Quality System Regulations (QSR) for companies in the industry. It emphasizes the need for gap assessments to identify compliance issues and the significance of aligning ISO structures with staff roles to ensure effective implementation and understanding of regulations.Chapters00:00 Introduction to QMSR and Compliance Insight00:31 Steps for Companies to Prepare for QMSR00:58 Benefits of QMSR Over QSR
2026-01-0715 minQuali-Tea with AnneThe Power of Authentic Storytelling"Understanding the customer journey is key to improving quality."In this conversation, Anne MacNeil interviews James Warren, founder and CEO of Share More Stories, about the importance of authentic storytelling in understanding employee and customer experiences. They discuss how storytelling can bridge the gap between employee engagement and customer satisfaction, the innovative tools used to measure emotional responses, and the role of AI in analyzing feedback. James shares success stories from various industries, highlighting the transformative power of storytelling in enhancing quality and engagement.To learn more check out:https...
2025-11-1026 minQuali-Tea with AnneExploring the World of PsychedelicsIn this conversation, Anne MacNeil and Karina Lahnakoski explore the world of psychedelics, discussing their definitions, clinical applications, and the regulatory landscape surrounding them. They delve into the manufacturing and quality control challenges specific to psychedelics, operational considerations in production, and the differences between botanical and synthetic sources. The discussion also touches on the future of psychedelics in medicine, highlighting the growing interest and potential benefits for mental health treatment.TakeawaysPsychedelics are psychoactive compounds that affect perception.Classical psychedelics include psilocybin, LSD, and...
2025-10-1417 minQuali-Tea with AnneUnlocking Faster Drug Approvals: The Role of the FDAIn this conversation, Anne MacNeil and Nu Trelle discuss the various pathways to accelerate drug approval, focusing on the role of the FDA and the importance of specific designations such as Fast Track, Breakthrough Therapy, and Orphan Drug Designation. They explore how these designations can expedite the drug development process, enhance patient access to innovative therapies, and the strategic considerations sponsors must take into account when navigating the regulatory landscape. The discussion emphasizes the need for safety and efficacy in drug development while ensuring timely access to treatments for patients in need.Chapters
2025-09-1637 minQuali-Tea with AnneIntegrating Human Potential with Six Sigma for Organizational GrowthIn this conversation, Anne MacNeil and Hannah Bauer explore the concept of human potential and its measurement within organizations. They discuss the importance of engagement, leadership, and communication styles in fostering a productive work environment. The conversation also highlights the significance of safety in manufacturing and the need for alignment between processes and human potential to achieve organizational goals.To learn more about Hannah check out: https://heartnomics.com/TakeawaysHuman potential is often overlooked in organizations.Engagement is critical for productivity and retention.
2025-09-0931 minQuali-Tea with AnneEmpowering women in leadershipIn this enlightening conversation, Anne MacNeil and Dianna Fioravanti-Ashikwe discuss the importance of women empowerment in leadership roles, the challenges women face in their careers, and the significance of authenticity and community support. Dianna shares her journey in male-dominated industries, the initiatives she has implemented to promote gender equality, and her insights on resilience and mentorship. The discussion emphasizes the need for women to embrace their unique strengths, build supportive networks, and leave a lasting legacy in their professional lives.
2025-07-2224 minQuali-Tea with AnneQuality assurance in additive manufacturing and 3D printingIn this conversation, Anne MacNeil speaks with Dani Mason from B9 Creations about the intricacies of additive manufacturing, particularly in regulated industries such as aerospace and medical devices. They discuss the importance of quality assurance, regulatory challenges, and the innovative applications of 3D printing technology. Dani emphasizes the need for a robust quality management system and the role of real-time feedback in maintaining production standards. The conversation also touches on the training required for operators and the current trends in additive manufacturing, including bioprinting and personalized medicine.
2025-07-1521 minQuali-Tea with AnneCurrent trends in Health CanadaIn this episode, Anne MacNeil and Karina Lahnakoski discuss the latest trends and updates from Health Canada, focusing on the impact of government changes, drug shortages, new guidance documents, inspection trends, and the role of AI in the pharmaceutical industry. They also highlight the importance of addressing nitrosamines in drug products and the need for compliance with upcoming regulations.
2025-07-0122 minQuali-Tea with AnneInsights from the BIO International ConventionThe conversation provides an insightful overview of the final day of the Bio International Convention, highlighting key trends, innovations, and reflections from the event. Melissa and Troy discuss the noticeable absence of the FDA, the influx of international participants, and the growing interest in AI and startups. They also emphasize the importance of collaboration and investment in the biotech sector, showcasing the excitement and optimism surrounding new technologies and student involvement in the industry.
2025-06-2409 minQuali-Tea with AnneBIO 2025 Day 3 Update: Networking and Innovations in BiotechThe conversation provides insights from the Bio International Convention, highlighting the busy atmosphere, networking opportunities, and the focus on technological innovations in the mRNA sector. The speakers discuss the challenges faced in delivery systems and quality compliance, emphasizing the importance of building trust and long-term partnerships in the industry. The regional representation and dynamics of the industry are also explored, showcasing the collaborative efforts and government support in advancing healthcare solutions.
2025-06-1918 minQuali-Tea with AnneExploring Bio 2025: Day Two InsightsIn this episode, Anne MacNeil and Melissa recap day two of the Bio 2025 conference in Boston, discussing the significant themes of licensing and AI in biotech, and the importance of GMPs in research and development. They also touch on global engagement and the need for regulatory help for startups looking to enter the U.S. market.
2025-06-1813 minQuali-Tea with AnneBIO 2025 Day 1: Key Insights and Emerging TrendsIn this episode, Anne MacNeil discusses the highlights from day one of Bio 2025 in Boston with Troy and Melissa from Compliance Insight. They explore the significant attendance, the absence of the FDA, emerging trends in the biotech industry, regulatory challenges, and the increasing role of AI in biotech. The conversation also touches on networking opportunities and the engagement strategies employed at the conference.
2025-06-1716 minQuali-Tea with AnneBridging Technology and Quality ManagementIn this conversation, Peter Swimm discusses the integration of AI in quality management systems, emphasizing the importance of compliance and safety. He highlights the challenges faced by organizations in adopting AI technologies, particularly in regulated industries like healthcare. The discussion covers successful applications of AI, the necessity of data hygiene, and the importance of building effective AI tools that enhance quality management processes. Swimm also addresses common pitfalls in AI implementation and the need for continuous evaluation and adaptation of AI systems to meet compliance standards.
2025-05-2628 minQuali-Tea with AnneNavigating Clinical Trials in Latin AmericaIn this episode, Anne and Julio Martinez-Clark discuss the intricacies of conducting clinical trials in Latin America, focusing on medical device innovation. Julio shares his extensive experience in the field, highlighting the unique challenges faced by startups in navigating regulatory environments, patient recruitment, and quality management. The conversation delves into the importance of establishing quality standards and certifications for clinical research sites, as well as the technological advancements that are shaping the future of clinical trials in the region. Ultimately, the discussion emphasizes the need for speed and quality in trial execution to meet the demands of investors and...
2025-05-0428 minQuali-Tea with AnneLessons from Data Integrity for AI ImplementationIn this conversation, Anne and Karina discuss the integration of AI in Quality Assurance (QA) and the lessons learned from data integrity requirements. They explore the regulatory landscape surrounding AI, its applications in drug discovery and clinical trials, and the importance of training and vendor qualification. The conversation highlights the potential risks associated with AI usage and emphasizes the need for proactive measures in organizations to ensure data integrity and compliance.To learn more check out Karina's article on LinkedIn: https://www.linkedin.com/posts/activity-7284932351883632641-fOQ6?utm_source=social_share_send&utm_medium=member_desktop_web...
2025-04-2226 minQuali-Tea with AnneMastering Hoshin Kanri for Strategic SuccessIn this conversation, Anne and Mark Reich discuss the principles of Lean Thinking and the significance of Hoshin Kanri in strategic planning. Mark shares his extensive experience with Toyota and how it shaped his insights into effective management practices. The discussion covers practical applications of Hoshin Kanri, the importance of engaging people in the process, and the need for continuous monitoring and improvement to achieve organizational goals. Mark emphasizes the necessity of having a dedicated process owner to sustain the Hoshin Kanri methodology and shares success stories from various industries.Check out more about...
2025-04-0639 minQuali-Tea with AnneNavigating the ANDA Process: A Comprehensive GuideIn this conversation, Anne and Nu Trelle from Compliance Insight Inc. discuss the Abbreviated New Drug Application (ANDA) process, which allows for the approval of generic drugs in the US. They explore the history of ANDAs, the requirements for filing, the significance of bioequivalence studies, and the importance of the Chemistry, Manufacturing, and Controls (CMC) section. The discussion also covers the FDA review process, timelines, and post-approval steps necessary for bringing a generic drug to market.
2025-03-0738 minQuali-Tea with AnneThe power of perspective: Carol's journeyIn this inspiring conversation, Carol Murray shares her incredible journey from a life-altering skydiving accident to becoming a dynamic speaker and fundraiser for medical research. She discusses the challenges she faced during her recovery, the importance of safety and risk management, and the role of medical research in her healing process. Carol emphasizes the significance of perspective in overcoming adversity and finding purpose in life, encouraging others to learn from her experiences.You can find out more about Carol at: https://www.carolmurray.ca/
2025-02-2832 minQuali-Tea with AnneNavigating Patient Access in HealthcareIn this conversation, Anne and Kathryn Munoz discuss the critical topic of patient access in healthcare, particularly in the biopharmaceutical industry. Kathryn shares her extensive experience in launching groundbreaking products and her recent transition to mental health with 4VITAHEALTH. They explore the challenges patients face in accessing medications, the importance of medication adherence, and how technology, including AI and telehealth, is transforming patient care. The discussion also touches on the integration of natural health solutions with traditional medicine and the evolving landscape of medical devices and patient support programs.
2025-01-2029 minQuali-Tea with AnneThe Critical Role of Knowledge TransferIn this podcast episode, the hosts discuss the importance of quality management and knowledge transfer as they enter 2025. They reflect on past experiences with knowledge transfer, the challenges faced, and the evolving landscape of training, especially in the wake of virtual training methods adopted during the COVID-19 pandemic. The conversation highlights the need for effective strategies to ensure knowledge retention, especially in industries like pharma where regulatory compliance is critical. The hosts also explore the role of AI in enhancing training and knowledge management, and the importance of continuous improvement in these processes.
2025-01-0922 minQuali-Tea with Anne2024 Predictions: What Came True?In this episode, the Quali-Tea team reflects on their predictions for 2024, discussing the accuracy of their forecasts regarding on-site audits, risk management, and the impact of AI in the pharmaceutical industry. They explore regulatory trends, investment dynamics, and emerging challenges, while also noting areas where their predictions fell short. The conversation highlights the evolving landscape of quality management and the importance of adapting to new developments in the industry.
2025-01-0119 minQuali-Tea with AnneThe complexity of OTC (over-the-counter) medicationsIn this enlightening conversation, Anne and Nu Trelle discuss the complexities of over-the-counter (OTC) medications, focusing on the regulations, approval processes, and the importance of compliance with OTC monographs. Nu Trelle shares insights from her extensive experience in the pharmaceutical industry, explaining the differences between OTC and prescription drugs, the significance of labeling for consumer safety, and the stringent requirements for bringing OTC products to market. The discussion also touches on the evolving nature of OTC monographs and the challenges faced by manufacturers in ensuring their products meet safety and efficacy standards.
2024-12-1223 minQuali-Tea with AnneAI and Robotics: Transforming Surgical ProceduresIn this conversation, Anne and Roger Smith delve into the world of robotic surgery and artificial intelligence, discussing the current landscape of surgical robots, the integration of AI in medical devices, and the regulatory challenges that accompany these advancements. They explore the implications of AI in surgical procedures, the role of independent robotic systems like the CyberKnife, and the future trends in robotic surgery. Additionally, they highlight the importance of quality professionals in navigating the evolving landscape of healthcare technology and regulatory requirements.
2024-11-2125 minQuali-Tea with AnneNavigating the FDA 510k Submission ProcessIn 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.
2024-11-1517 minQuali-Tea with AnneMastering Tough Talks in QualityIn 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.
2024-10-2522 minQuali-Tea with AnneUnderstanding FDA Oversight on LDTsIn 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.
2024-10-1721 minQuali-Tea with AnneChanges for cosmetics companies with The Modernization of Cosmetics Regulation Act (MoCRA)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...
2024-09-1628 minQuali-Tea with AnneEffective Interview Questions for Quality PositionsIn 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.
2024-09-0922 minQuali-Tea with AnneThe Power of Kindness in Building a Quality CultureMichael 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...
2024-08-0125 minQuali-Tea with AnneBenefits of Being a Qualified AuditorIn 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.
2024-07-2417 minQuali-Tea with AnneThe best way to close out an auditIn this episode, part two in the series on auditing. The hosts discuss the best way to close out an audit.
Schedule time to organize your thoughts and findings before the closeout meeting
Address all observations and findings with the auditee beforehand to avoid surprises
Focus on the positive aspects and helpfulness of the employees
Be professional, polite, and appreciative throughout the closeout process
2024-07-1125 minQuali-Tea with AnneWhere to start when conducting an auditIn 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...
2024-06-2923 minQuali-Tea with AnneQ&A with Anne: Answering all your burning quality questionsIn 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.
2024-06-2127 minQuali-Tea with AnneMastering Work-Life Balance: Tips for Quality ProfessionalsThe 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.
2024-06-1422 minQuali-Tea with Anne#BIO2024 International Convention wrap up with Compliance-InsightThe 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...
2024-06-0823 minQuali-Tea with AnneDay 3 at #BIO2024 International with Compliance-InsightThe 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.
Investor interest in new businesses and trends
Growth of companies in clinical phases
Increased focus on regulatory affairs
Collaboration and partnership opportunities
Recruitment of consultants from the convention
2024-06-0621 minQuali-Tea with AnneDay 2 at #BIO2024 International with Compliance-InsightTroy 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.
2024-06-0527 minQuali-Tea with AnneDay 1 @BIO International with Compliance InsightThis 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.
2024-06-0415 minQuali-Tea with AnneContinuing the conversation into Material QualificationIn 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
Material qualification and supplier qualification are two separate processes that go hand in hand and require careful consideration.
Risk assessment plays a crucial role in determining the steps to take when qualifying a new material or replacing an existing one.
Documentation and change control are essential...
2024-05-3119 minQuali-Tea with AnneThe leaders role in change management and transformationIn 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...
2024-05-2425 minQuali-Tea with AnneImproving quality through supplier oversightIn 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.
2024-05-1625 minQuali-Tea with AnneThe First Step of Process and Culture changeIn 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...
2024-05-0924 minQuali-Tea with AnneUnderstanding Acceptable Quality Level (AQL)"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...
2024-05-0227 minQuali-Tea with AnneTips for Successful Regulatory SubmissionsIn 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.
2024-04-2520 minQuali-Tea with AnneData Integrity: A hot topicIn 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...
2024-04-1822 minQuali-Tea with AnneTop FDA 483's and how to avoid themIn 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.
2024-04-1132 minQuali-Tea with AnneBuilding a Simple Change Management ProcessIn 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.
2024-04-0419 minQuali-Tea with AnnePresenting in a regulatory inspection: what to say and what not to sayIn 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 w...
2024-03-2130 minQuali-Tea with AnneTaking the leap from QualityThe 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...
2024-03-1431 minQuali-Tea with AnneCelebrating women in Pharma and QualityIn 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...
2024-03-0814 minQuali-Tea with AnneManaging remote and hybrid teamsIn 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
Managing...
2024-03-0829 minQuali-Tea with AnneHow Cell and Gene Therapy manufacturing differs from traditional drug manufacturingIn 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...
2024-02-2922 minQuali-Tea with AnneLet's focus on trainingIn 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
Understanding...
2024-02-2328 minQuali-Tea with AnneQuality in a digital worldThis week Steven Keizer shares his insight into how digitization, digitalization and digital transformation are changing the way we look at quality.
2024-02-0920 minQuali-Tea with AnneTech transfers and method validation top tips and risksIn 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...
2024-02-0224 minQuali-Tea with AnneQuality Risk Management ICH Q9In 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.
2024-01-2624 minQuali-Tea with AnneQuali-Tea 2024 PredictionsIt's time for our annual predictions for the world of quality in 2024.
2024-01-1918 minQuali-Tea with AnneBack to work!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.
2023-12-2216 minQuali-Tea with AnneNetworkingThis 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/
2023-12-1428 minQuali-Tea with AnneDeviation Backlog: how to address the messIn this quick podcast snippet I provide my top five tips for reducing a deviation backlog.
2023-12-0709 minQuali-Tea with AnneWriting a good procedureIn 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.
2023-11-3033 minQuali-Tea with AnneWhat is Salesforce AppExchange?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.
2023-11-2328 minQuali-Tea with AnneInformation sharing in the quality and regulatory worldIn 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.
2023-11-1620 minQuali-Tea with AnneCell and Gene TherapyIn 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.
2023-11-0917 minQuali-Tea with AnneOutsourcing: The pros and consThe pros and cons of outsourcing in the quality world.
2023-11-0220 minQuali-Tea with AnneGamification in trainingThe 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.
2023-10-2626 minQuali-Tea with AnneConducting a good quality investigation Part 2: CAPAIn 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.
2023-10-1915 minQuali-Tea with AnneChoosing the right eQMS for youAt 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.
2023-08-1426 minQuali-Tea with AnneEveryone is a leader in qualityIn 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.
2023-08-0721 minQuali-Tea with AnneHow to conduct a good quality investigationIn 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.
2023-07-2816 minQuali-Tea with AnneIVDR implementation and the impact on clinical trialsIn 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.
2023-04-2029 minQuali-Tea with AnneQuali-Tea with Anne Supply Chain ManagementIn this episode we discuss the current challenges of supply chain managment, how to adapt and mitigate risks.
2023-02-2823 minQuali-Tea with Anne2023 in Quality, what you can expect and our predictions for the top quality trendsIn 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.
2023-01-2430 minQuali-Tea with AnneBuilding and maintaining Key Performance Indicators that are meaningful to the Quality SystemIn this episode we talk about KPI’s and quality objectives, how to build metrics that are meaningful and effective to improving the quality system.
2022-10-1825 minQuali-Tea with AnneHow to build and maintain an effective training programIn 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.
2022-09-1223 minQuali-Tea with AnneManaging change and transformationIn 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.
2022-06-2621 minQuali-Tea with AnneKeeping the c in cGMPThe 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.
2022-05-0125 minQuali-Tea with AnneQuali-Tea with Anne Podcast Episode#2In 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.
2022-03-2726 min
Quali-Tea with AnneQuali-Tea with Anne Episode #1 Quality Culture ChatA group of Quality professionals chat about how to build a positive quality culture in any organization.
2022-03-0627 min2022-03-0500 min
Craig & Friends167: Darian Darling!The fabulous Darian Darling joins me to talk glaMOUR, her brilliant makeup and styling for the likes of Jake Wesley Rogers, Semi Precious Weapons & the Lady Gaga, working with Trixie Mattel, NYC nightlife & NDAs, Jobriath, being queen of the brunch-time world, hot-tub terrors, Miss Guy, “Crocodile Dundee”, creative directing, “STAR 80”, Jem & The Holograms, Lady Stardust, Anne Carlisle & “Liquid Sky”, the best high-school in America, “Veronica Mars”, Amanda LePore, Loni Anderson and MORE!Support this show and get lots of hott bonus content by going to https://www.patreon.com/CraigAndFriends - see which reward tier works best for you! You’ll get ad-f...
2022-01-121h 50
Two Old Farts Talk Sci-FiThe Exorcist pt. 2
This is the second episode of our two-part Exorcist episode.
We will continue our look at The Exorcist (the book by William Peter Blatty and the film by William Friedkin).
We will do our Dream Cast and Schrödinger's Cast for the 1973 film. We will look at six key characters in the movie, and pick the actor/actress that would have best fit that role, and also an outside-the-box cast:
Regan MacNeil | Linda Blair
Chris MacNeil | Ellen Burstyn
Father Damien Karras | Jason Miller
Father Lankester Merrin | Max von Sydow
Lt. William Kinderman | Lee J. Cobb
Burke Dennings | Jack Macgowran
Troy H...
2021-11-011h 11
Two Old Farts Talk Sci-FiThe Exorcist pt. 1
The Exorcist is a book by William Peter Blatty, a film by William Friedkin, and there were sequels. The novel (1971) and movie (1973) tell the story of demonic possession. An actress's daughter is the victim, and after exhausting all medical and psychological possibilities, they are left with a Catholic ritual to "exorcise" the demon from the child.
The book received a lot of praise, and the movie was a hit. Not since Psycho and Rosemary's Baby has a film gripped the public's imagination.
Here are six key characters in the novel and movie, and the actor/actress that played the role...
2021-10-1652 min
Going North PodcastEp. 375 – “Aces High, Jokers Wild” with O. E. Tearmann (@ETearmann)“Typos are like mushrooms. They grow overnight.” – Olivia Wylie Today’s featured bestselling writing duo is Olivia Wylie and E.S. Argentum aka O.E. Tearmann. O.E. and I had a fun chat about their book series, “Aces High, Jokers Wild”, their writing process, and tons more!! Key Thing’s You’ll Learn: The meaning behind their pen name. How they learn from each other during their writing process. What their writing “why” is. What influence do they hope their work will have? O. E. Tear...
2021-07-1051 min
Glass in Session® WinecastWines of Anjou, the Musketeers ... and a Salad to Go? | S7E2Wines from Anjou, a region in the Middle Loire Valley in France, were the absolute favorite of D'Artagnan the Gascon, the so-called 4th musketeer. Throughout Alexandre Dumas's saga beginning with "The Three Musketeers" and ending with "The Man in the Iron Mask" the white wines are vaunted and revered, particularly by D'Artagnan. This episode explores the wines of Anjou, and the wines the 17th century musketeers actually might have been drinking. Then we take a small side trip to discover why, potentially, Alexandre Dumas was specific in naming the regional wines in his works.
2021-05-2819 min
Mental Health Explained: A Dr. Alex MacNeil PodcastSelf-Compassion, Featuring Dr. Anne Gehrenbeck-Shim, PhDSelf-Compassion, Today's Guest: Dr. Anne Gehrenbeck-Shim, PhD.
Disclaimer:The information contained and documents referenced in this Podcast are for entertainment, educational and informational purposes only, and are not intended as, and shall not be understood or construed as professional medical or health treatment, diagnosis, or advice. Regardless of anything to the contrary, no information contained in, nor document referred to in this Podcast should be understood as a recommendation that you should not consult with a medical or health professional to address your particular situation. We strongly encourage that our listeners consult with medical providers or qualified mental health providers...
2021-04-1948 min
Khôra Podcast1.6: A Maze of StardustWith the Argo back up and running, the crew sets out into the debris field around Knossos with Ariadne- but the engineer may not be all she seems. --Content warnings can be found at the end of the show notes. The transcript can be found at https://khorapodcast.github.io/khorapod_transcripts/--Khôra Podcast is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License. This episode was produced by A.L Emmet and directed by Sats Di Stefano, Celeste Lang, and Ibrahim Steel. It starred Kit MacNeil as...
2021-03-2240 min
Miss ThingOh What A She-eling!Miss Thing is celebrating Pride and Canada Day in the only way we know how- talking about our favourite Canadian gay icons. We're bringing you another socially distant Skype episode of Miss Thing and this time we are diving into a different compilation series- Oh What A Feeling: A Vital Collection of Canadian Music. Oh What A Feeling is a Juno Awards compilation chronicling the very best of Canadian music from the 60s to the 00s. We're picking out our favourite tracks by ladies and giving you all the hot takes you never asked for. We're talking everything from...
2020-06-3000 min
Irish & Celtic Music PodcastMaid on the ShoreCome to the join the maid on the shore with the Irish & Celtic Music Podcast. Flook, Stonecircle, Molly Bauckham, Julia Lane, Beyond the Pale, Kellswater Bridge, Anne Roos, Ceili Moss, Celia Ramsay & Shay Black, Hibernia, Erin's Guild, Jil Chambless, Ed Miller and Scooter Muse, Paisley Close, Runa, Ryan MacNeil, The Fire Inside I hope you enjoyed this week's show. If you did, please share the show with ONE friend. The Irish & Celtic Music Podcast is here to build our community and help the incredible artists who so generously share their music with you...
2020-06-181h 13
Daily News Update from CHLY 101.7FMMorning News Update for April 22, 2020Hundreds of people had questions for Island Health officials at a virtual town hall meeting last night. 300 queries were asked ahead of time, and a dozen more during the livestream broadcast. The questions ranged from when cancelled surgeries will resume to whether COVID-19 sticks to hair or money. The CEO of Island Health, Kathy MacNeil said she expects non emergency surgeries will be rescheduled starting in mid-May. The Island's Chief Medical Officer fielded questions about testing, when social isolation rules could be relaxed and why some remote and island areas aren't being locked down. Dr. Richard Stanwick said officials...
2020-04-2200 min
Historial RoastFictional Roast: Horror Movie Mayhem October 17th, 2017On October 17th, 2017 Chucky (Child's Play), Jason Voorhees (Friday The 13th), Carrie White (Carrie), Regan MacNeil (The Exorcist), Pennywise (It), and Freddy Krueger (Nightmare on Elm Street) were roasted by Alex Hooper, Michael D'Bey, Brandie Posey, Heather Anne Campbell, Matt McCarthy, and Hampton Yount.
Hosted by Eddie Furth and Ryan Pigg.
Produced by Eddie Furth, Ryan Pigg, and Samee Junio
2018-11-241h 28
Grab the Top Full Trial Audiobooks in Mystery, Thriller & Horror, Police & DetectiveLament for Bonnie by Anne EmeryPlease visit https://thebookvoice.com/podcasts/1/audiobook/321642 to listen full audiobooks. Title: Lament for Bonnie Series: #9 of Collins-Burke Mysteries Author: Anne Emery Narrator: Morgan Hallett, Tandy Cronyn, Erin Moon Format: Unabridged Audiobook Length: 12 hours 7 minutes Release date: October 28, 2016 Genres: Police & Detective Publisher's Summary: The ninth mystery in a series that 'gets better with every book' (Globe and Mail) Twelve-year-old Bonnie MacDonald - the beloved stepdancing, fiddling youngest member of Cape Breton's famed Clan Donnie band - vanishes after a family party. There was no stranger spotted lurking around, but no one thinks for one minute that Bonnie ran away. Maura M...
2016-10-2805 min
Ghost ChroniclesGhosts of the USS Constituion with Ellen MacNeilAnne and Ron are joined by Ellen MacNeil of the Ghosts of New England to discuss her investigation of Old Ironsides, the USS Constitution. What did she find? Tune in and find out!
2013-09-1856 min
MCASD: Rising Tide - Film and Video Works From the MCA Collection, SydneyExhibition OverviewFocusing on selections of Australian video art from the Museum of Contemporary Art, Sydney’s permanent collection, Rising Tide: Film and Video Works from the MCA Collection features works by Destiny Deacon, Virginia Fraser, Shaun Gladwell, Anne Kay, The Kingpins, Jess MacNeil, Todd McMillan, Kate Murphy, David Noonan, Susan Norrie, Patricia Piccinini, Jane Polkinghorne, Tony Schwensen, and Daniel von Sturmer. Rising Tide: Film and Video Works from the MCA Collection, Sydney is an exhibition co-organized by MCASD and the Museum of Contemporary Art, Sydney and is curated by Dr. Stephanie Hanor, Senior Curator, MCASD, and Rachel Kent, Senior Curator, MCA Sy...
2009-03-0202 minMCASD: Rising Tide - Film and Video Works From the MCA Collection, SydneyArtist ArchiveFocusing on selections of Australian video art from the Museum of Contemporary Art, Sydney’s permanent collection, Rising Tide: Film and Video Works from the MCA Collection features works by Destiny Deacon, Virginia Fraser, Shaun Gladwell, Anne Kay, The Kingpins, Jess MacNeil, Todd McMillan, Kate Murphy, David Noonan, Susan Norrie, Patricia Piccinini, Jane Polkinghorne, Tony Schwensen, and Daniel von Sturmer. Rising Tide: Film and Video Works from the MCA Collection, Sydney is an exhibition co-organized by MCASD and the Museum of Contemporary Art, Sydney and is curated by Dr. Stephanie Hanor, Senior Curator, MCASD, and Rachel Kent, Senior Curator, MCA Sy...
2009-03-0201 minMCASD: Rising Tide - Film and Video Works From the MCA Collection, SydneyOwlFocusing on selections of Australian video art from the Museum of Contemporary Art, Sydney’s permanent collection, Rising Tide: Film and Video Works from the MCA Collection features works by Destiny Deacon, Virginia Fraser, Shaun Gladwell, Anne Kay, The Kingpins, Jess MacNeil, Todd McMillan, Kate Murphy, David Noonan, Susan Norrie, Patricia Piccinini, Jane Polkinghorne, Tony Schwensen, and Daniel von Sturmer. Rising Tide: Film and Video Works from the MCA Collection, Sydney is an exhibition co-organized by MCASD and the Museum of Contemporary Art, Sydney and is curated by Dr. Stephanie Hanor, Senior Curator, MCASD, and Rachel Kent, Senior Curator, MCA Sy...
2009-03-0201 minMCASD: Rising Tide - Film and Video Works From the MCA Collection, SydneyOpera House Steps December, The Shape of BetweenFocusing on selections of Australian video art from the Museum of Contemporary Art, Sydney’s permanent collection, Rising Tide: Film and Video Works from the MCA Collection features works by Destiny Deacon, Virginia Fraser, Shaun Gladwell, Anne Kay, The Kingpins, Jess MacNeil, Todd McMillan, Kate Murphy, David Noonan, Susan Norrie, Patricia Piccinini, Jane Polkinghorne, Tony Schwensen, and Daniel von Sturmer. Rising Tide: Film and Video Works from the MCA Collection, Sydney is an exhibition co-organized by MCASD and the Museum of Contemporary Art, Sydney and is curated by Dr. Stephanie Hanor, Senior Curator, MCASD, and Rachel Kent, Senior Curator, MCA Sy...
2009-03-0207 minMCASD: Rising Tide - Film and Video Works From the MCA Collection, SydneyWelcome to the JingleFocusing on selections of Australian video art from the Museum of Contemporary Art, Sydney’s permanent collection, Rising Tide: Film and Video Works from the MCA Collection features works by Destiny Deacon, Virginia Fraser, Shaun Gladwell, Anne Kay, The Kingpins, Jess MacNeil, Todd McMillan, Kate Murphy, David Noonan, Susan Norrie, Patricia Piccinini, Jane Polkinghorne, Tony Schwensen, and Daniel von Sturmer. Rising Tide: Film and Video Works from the MCA Collection, Sydney is an exhibition co-organized by MCASD and the Museum of Contemporary Art, Sydney and is curated by Dr. Stephanie Hanor, Senior Curator, MCASD, and Rachel Kent, Senior Curator, MCA Sy...
2009-03-0201 minMCASD: Rising Tide - Film and Video Works From the MCA Collection, SydneySandmanFocusing on selections of Australian video art from the Museum of Contemporary Art, Sydney’s permanent collection, Rising Tide: Film and Video Works from the MCA Collection features works by Destiny Deacon, Virginia Fraser, Shaun Gladwell, Anne Kay, The Kingpins, Jess MacNeil, Todd McMillan, Kate Murphy, David Noonan, Susan Norrie, Patricia Piccinini, Jane Polkinghorne, Tony Schwensen, and Daniel von Sturmer. Rising Tide: Film and Video Works from the MCA Collection, Sydney is an exhibition co-organized by MCASD and the Museum of Contemporary Art, Sydney and is curated by Dr. Stephanie Hanor, Senior Curator, MCASD, and Rachel Kent, Senior Curator, MCA Sy...
2009-03-0201 minMCASD: Rising Tide - Film and Video Works From the MCA Collection, SydneyInto the vacuum of future eventsFocusing on selections of Australian video art from the Museum of Contemporary Art, Sydney’s permanent collection, Rising Tide: Film and Video Works from the MCA Collection features works by Destiny Deacon, Virginia Fraser, Shaun Gladwell, Anne Kay, The Kingpins, Jess MacNeil, Todd McMillan, Kate Murphy, David Noonan, Susan Norrie, Patricia Piccinini, Jane Polkinghorne, Tony Schwensen, and Daniel von Sturmer. Rising Tide: Film and Video Works from the MCA Collection, Sydney is an exhibition co-organized by MCASD and the Museum of Contemporary Art, Sydney and is curated by Dr. Stephanie Hanor, Senior Curator, MCASD, and Rachel Kent, Senior Curator, MCA Sy...
2009-03-0201 min