phd in quality improvement

Doctor of Philosophy in Health Quality

Click here to learn how to apply!

The PhD in Health Quality (PhDHQ) will prepare experts who will improve the delivery of healthcare through teaching, developing new methodologies and theoretical frameworks, as well as testing innovation in the field of health quality. The PhDHQ program offers a collaborative approach to comprehend and address the complexities within the healthcare system. Graduates of the program will be prepared to take senior leadership roles in health quality portfolios in practice and policy settings across Canada and will also be educated to assume tenure track positions in university programs. While the degree is research intensive, it will also be grounded in pragmatism and will help prepare independent researchers for quality improvement research and developing leadership capabilities in health settings.

The PhDHQ program is a four-year, interdisciplinary program using a combination of synchronous and asynchronous study as well as interactive online videoconferencing. The PhDHQ program consists of five (5) courses in year one, including an internship over the summer months. The internship will be tailored to the learners’ interests and to broadening their perspectives on health quality. In the fall term of year two, students complete the comprehensive exam. In the winter and summer terms of year two (2) students will focus on the development of their thesis proposal and complete HQRS 905 Current Topics in Health Quality. After a successful oral examination of the thesis proposal, students submit their project for ethics review and then proceed to data collection, analysis, and writing. The thesis requires independent, original research and makes up at least two-thirds of the time normally required for the program. Upper year students are expected to visit campus at least once per year; students are required to attend the final thesis examination in person. Nurtured by close mentoring relationships with faculty supervisors, the Queen’s model is to ensure graduate students present and publish their research, and normally complete their program in 4 years.

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Doctorate in Total Quality Management

The Doctorate  of  Total Quality Management program will provide you with a thorough grounding in the theory and application of the various quality management concepts that form the basis of QM to help you design, implement, and manage quality systems within your organization.

The focus is primarily on understanding Total Quality Management (TQM), quality frameworks and methodologies, quality standards, and quality awards,

A key component of the Quality Management program is the practical development of key skills in a real-world environment. This includes interaction with the industry through guest lectures, site visits, and a business-focused management project that will help you to critically analyze challenging scenarios relevant to your area of professional practice.

• Process and organizational Behaviour
• Marketing Management
• Operations and Supply Chain Management
• Statistics for Quality Management
• Management of Service Quality
• Advanced Quality Tools
• Business Excellence and Quality Management Systems

ABOUT UNIVERSITY

• The American University of Science& Technology (AUST) was founded in order to fulfill the need for non-traditional higher education in the world.
• We believe that we are capable of doing this.
• Address :8 Green St. kent,dover, delaware,.USA Postal code:19901 Email:[email protected]

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Healthcare Quality and Safety, MHQS

Mission Statement

The mission of the Perelman School of Medicine’s Master’s degree in Healthcare Quality and Safety (MHQS) is to train the next generation of healthcare leaders and practitioners in the science of healthcare quality and patient safety.

Program Goals

The goal of the MHQS is to provide in-depth didactic instruction and hands-on experience to current healthcare professionals who aim to improve the quality and safety of healthcare, locally, regionally or nationally. This program will prepare students to pursue careers in healthcare administration and leadership that may be broad (e.g. director of quality and safety for a healthcare system or hospital) or more focused (e.g. positions that oversee population health, health equity, patient safety, value-based care for a healthcare system, department, or organization). Some graduates will combine their clinical and academic careers with a focus on healthcare quality and safety leadership, others will go on to pure leadership positions.

https://chips.med.upenn.edu/masters/program-description/ 

The degree and major requirements displayed are intended as a guide for students entering in the Fall of 2023 and later. Students should consult with their academic program regarding final certifications and requirements for graduation.

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Outline: Quality Improvement

Lisa Shieh, MD, PhD

Co-Directors

Anu Phadke, MD

Amelia Sattler, MD

Objectives and Goals

Quality Improvement is an application area in the Scholarly Concentration program. The goals of our program are to expose students to the primary issues in the field of Quality Improvement, and give them the tools to begin addressing these through hands-on field research. Some specific goals include:

• Expose students to quality improvement methodology
• Engage students in quality improvement projects as a part of their medical education
• Promote excellence in the areas of hospital metric data analysis and implementation science
• Prepare students to deliver safe and high-value care in the future
• Promote scholarship in QI

Requirements

Students who pursue Quality Improvement are required to complete a total of 6 units which may be fulfilled by attending courses in the Course Work  page.

Reshaping the future of healthcare

Reach for the next level of excellence with our graduate programs that develop leadership in the healthcare system. With focused cohorts to build a supportive team and Kellogg management training to implement effective change, the executive-style Master's and Certificate programs are a natural stepping stone for working healthcare professionals.

Our Programs

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Meet Our Alumni

Kevin J. O'Leary, MD, MS

The Master’s Program in Healthcare Quality and Patient Safety provides me with the knowledge and skills to better contribute and lead current and future efforts at my hospital."

Class of 2009 Chief, Division of Hospital Medicine Professor of Medicine, Northwestern University Feinberg School of Medicine

“I remember the uneasy feeling I got from time to time during my internal medicine residency. Whether it related to a patient handoff (or pickup), diagnostic confusion, or an ominous feeling that something was about to fall through the cracks, things often just didn’t feel right. The delivery of our care was full of redundancy and distractions as well. For a while, these concerns went away as I finished my residency and concentrated my clinical effort on primary care."

Mavis Prall, MSJ, MS

I have no doubt that the content of the program, and the contacts I made through the program, will continue to serve me personally and professionally for many years to come."

Class of 2010 Program Director, Content Marketing IBM Watson Health

"Years ago I earned a Master's in Journalism from Northwestern University, and I had been in healthcare communications for 11 years when I decided to expand and deepen my knowledge of quality and patient safety. I was worried that my non-clinical background would hinder me, but the instructors and my fellow classmates were extraordinarily supportive. I found the program to be stimulating, exciting and rewarding. The program immediately expanded my professional opportunities. My employers, clients and colleagues are extremely impressed with the knowledge I gained in the program. I have no doubt that the content of the program, and the contacts I made through the program, will continue to serve me personally and professionally for many years to come."

Explore Student Outcomes

Quality Improvement, Evidence-Based Practice, and Research

Affiliation.

• 1 Susan B. Fowler, PhD, RN, CNRN, CRRN, FAHA, FCNS , is a Nurse Scientist, Orlando Health, Orlando, Florida, and Faculty, Walden University and Thomas Edison State University, Trenton, New Jersey.
• PMID: 33955937
• DOI: 10.1097/NHH.0000000000000941
• Evidence-Based Practice*
• Quality Improvement*

Quality and safety

Led by: Professor Stephen Campbell , Dr Maria Panagioti and Professor Darren Ashcroft

This theme focuses on conducting innovative, needs-driven and applied research to improve quality of care and patient safety in primary care, particularly in general practice and community pharmacy, as well as the interface of hospital and social care.

We are an interdisciplinary team of researchers and clinicians in primary care, pharmacy, mental health, informatics, epidemiology and statistics. We develop and test the mechanisms for high-quality, safer primary care systems, which are integrated with hospital and community settings.

Our aims are to:

• Work together with patients, carers, members of the public and healthcare providers using a co-design and learning approach that takes a shared responsibility approach to better quality of care and making health and care safer
• Develop ground-breaking digital and behavioural interventions to facilitate effective communication between patients, healthcare providers and healthcare systems creating cycles of continuous safety improvement.
• Create evidence-based strategies to reduce common sources of patient safety problems (e.g. medication and prescribing) and improve safety in marginalised groups of patients.

Available projects

The below projects are available within this theme. The links will take you to the full project descriptions on FindAPhD.com, from where you can also email the lead contact for each project with any questions.

• Mental health outcomes and utilisation of mental health care services in older adults in primary care (Dr Rathi Ravindrarajah)

Next steps and contacts

If you are considering applying for a studentship for a project within this theme, please email the research contact for the relevant project to discuss your potential application and ask any questions you may have.

Professor Stephen Campbell Email: [email protected]

Dr Maria Pangoti Email: [email protected]

If after speaking to the leads you still wish to be considered for the programme, and you meet our eligibility criteria, you must complete a single online application, following the instructions on the how to apply page.

Quality, Patient Safety and Outcomes Research, Certificate

Bloomberg school of public health, quality, patient safety and outcomes research certificate program, note: this certificate program can be completed entirely online.

The certificate program is designed for graduate students from the Johns Hopkins Schools of Public Health, Medicine, and Nursing and health-related professionals interested in quality, patient safety, and outcomes research.

EDUCATIONAL OBJECTIVES

Those who complete the certificate program will gain competencies in quality, patient safety, and outcomes research; however, the program does not provide training in conducting research. Students completing the certificate program will be able to:

• Describe several frameworks and theories for assessing and improving the quality of medical care;
• Describe current key policy and programmatic areas in quality of care;
• Understand how to assess quality of care for a medical condition; 
• Describe key elements of published quality assessment and improvement studies;
• Understand how to develop a workable quality improvement and evaluation plan.
• Recognize the extent of problems in patient safety in medical care;
• Describe the role of various systems and factors in creating safety and in causing errors and adverse events; 
• Discuss problems and issues in measuring and reporting safety;
• Demonstrate knowledge of the basics of conducting an incident investigation and disclosing an adverse event;
• Design solutions to improve patient safety;
• Understand the ethical, legal, and regulatory implications related to patient safety.

Patient Outcomes Research

• Argue for the importance and challenges of using patient and consumer-reported measures in research, clinical practice, and program evaluation;
• Compare the different types of instruments available to measure health-related quality of life; 
• Critique the use of commonly used patient-reported outcomes in specific applications;
• Plan the development of a new questionnaire;
• Understand the role of patient-centered outcomes research in improving health, including its place in the U.S. research portfolio, the importance of stakeholders in the research process, and policy implications related to implementation;
• Identify study designs and methodologies unique to patient outcomes research.

Contact information and complete information about applying to the certificate program are available on the  certificate program page  on the Bloomberg School of Public Health website. 

Sponsoring Department

Health Policy and Management

REQUIREMENTS FOR SUCCESSFUL COMPLETION

The certificate program requires a minimum of 21 term credits, including four required courses and at least six credits of elective courses. All required and elective courses must be taken for a letter grade; a minimum grade of C is required in all certificate coursework, and students must maintain a 2.75 or better overall GPA for all certificate coursework. The certificate program length is flexible and varies from student to student. However, the program must be completed within three years.

The student should review the  section of the website that addresses completion  before completing certificate program requirements. The student's transcript will not indicate that the certificate was earned until the Notification of Completion has been submitted, verified by the certificate program, and processed by the Registrar.

COURSE OF STUDY

Students should check the BSPH  course directory  to confirm when the courses are offered. Students should also check for prerequisites and whether instructor consent is required.

• Psychological medicine and clinical neurosciences
• Centres, groups and units
• Clinical innovation
• Publications

Quality improvement and patient safety (DRAFT)

The field of patient safety is the coordinated effort to prevent harm, caused by the process of health care itself, from occurring to patients. ​

We aim to determine the frequency, burden and preventability of healthcare associated harm in primary and emergency care settings, and to develop and implement interventions to improve patient safety in priority areas.​

We host a team of health services researchers and academic clinicians with expertise for:

• investigating the frequency and avoidability of significant harm in healthcare, with particular expertise in primary care, secure environments and end-of-life care contexts
• methodological innovation for identifying, structuring and sharing learning from patient safety incidents within (national) and between countries (international), including the development of classification systems and taxonomy
• evaluating the development and implementation of interventions using mixed methods to minimise harm to patients in health and social care settings.

Current projects

Collaborations.

We host a collaboration with other Cardiff University schools called the Welsh Ergonomics and Safer Patients Alliance (WESPA) , an interdisciplinary group of researchers (Cardiff Business School, School of Engineering, School of Dentistry) and clinicians undertaking research and service evaluation to enable innovation and implementation of practices to improve patient safety in healthcare.

We also collaborate closely with the Opthalmic Public Health Group at the School of Optometry and Vision Sciences.

Researchers

Professor Andrew Carson-Stevens

Clinical Professor of Patient Safety and Quality Improvement

Dr Natalie Joseph-Williams

Senior Lecturer in Improving Patient Care, Joint Academic Lead for Public Involvement and Engagement

Professor Adrian Edwards

Director, Division of Population Medicine

Dr Alison Cooper

Associate Academic Fellow

Delyth Price

Research Assistant

Stuart Hellard

Data Manager

Dr Joy McFadzean

GP Clinical Lecturer

Dr Thomas Purchase

Academic GP Fellow

Honorary staff

Real world impact

Our research creates benefits across health, society and the economy.

Explore our case studies

School of Medicine

The School of Medicine is a major international centre for teaching and research, and committed to the pursuit of improved human health.

• Email: [email protected]

Our location

School of Medicine, UHW Main Building, Heath Park, Cardiff, CF14 4XN

Athena SWAN Award

We are proud to hold the Athena SWAN Bronze Award and we continually strive to ensure gender equality.

• Prospective Students
• Current Students
• Residents & Fellows
• Give to SMHS

The Health Care Quality Program

The Health Care Quality Program at the George Washington University (GW) School of Medicine and Health Sciences (SMHS) is an interdisciplinary program designed for healthcare professionals who want to advance their career and become leaders in Health Care Quality & Patient Safety. Our competency-based curriculum is informed by the National Center for Healthcare Leadership (NCHL) and the National Association for Healthcare Quality (NAHQ).

As one of the first two quality and safety programs in North America to achieve national accreditation from the Commission of Accreditation of Healthcare Management Education (CAHME), our program aligns with the highest quality and safety education standards established by leading academics and practitioners. 

Our mission is to meet an emerging demand for quality and patient safety specialists who have the capacity and competence to grow and sustain a culture of continuous improvement at all levels and within every sector of the healthcare delivery system. Through a rigorous curriculum and an active-learning environment, graduates will be prepared for quality and patient safety leadership, management, and research positions within health care organizations or policy agencies. 

Through the program, students can receive a  Graduate Certificate in Health Care Quality  or  Master’s in Health Sciences in Health Care Quality , both available online.

Accepting students since 2010, the program has earned a reputation of graduating leaders in the field, who go on to transform health care in their communities.

Graduate Certificate in Health Care Quality

The George Washington University's (GW) Online Graduate Certificate in Health Care Quality is a fully online, 18 credit-hour graduate certificate program built on an interdisciplinary, practice-based curriculum and developed to prepare you for a leadership role in quality-based healthcare.

MSHS in Health Care Quality

Created in partnership with the National Committee for Quality Assurance (NCQA), the online Master of Science in Health Sciences (MSHS) in Health Care Quality was developed for patient safety and quality leaders to advance their career and meet the growing demand for patient-centered, quality-based care.

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Doctor - Total Quality Management

Distance degree programs for adults & professionals., bircham international university - adult degree programs online., doctor ph.d. degree - business & media, total quality management via distance learning.

The continuous search for excellency and quality is crucial to yield better products, superior services, and successful business. This Doctor Ph.D. Degree explores the principles of leadership, strategic planning, marketing, information technology, human resources, process management, and business results. It uses an integrated systems approach to achieve continuous improvement and reviews the application of total quality management to diverse organizations such as manufacturing, service, small business, government, health care, etc.

Academic Supervisor : Ronald D. Fite More information about this academic supervisor at Bircham University Human Network. More info...

The Doctor Ph.D. Degree online via distance learning offers students the highest level of specialization a discipline can offer. More info...

* 45 to 72 academic credits above a Master's program. * Average Duration: 24 months. * Program Structure: 70% textbooks + 30% Thesis. * Admission is open for adults over 27 years of age. * Master's degree or international equivalent (5 years of study) is required for admission.

Fees include all: Program of study, textbooks, study guide, evaluation and assessment, diploma, and transcript. Cost per BIU earned postgraduate credit: 130 Euros (170 US$) Cost per transferred credit from previous education and/or professional experience if required: 20 Euros (25 US$)

45 ... 72 Academic credits Tuition Fee :Min. 5.850 Euros (7.650 US$) ... Max. 9.360 Euros (12.240 US$).

"It is not the degree that makes a man great, it is the man that makes the degree great." Niccolò Machiavelli.

Payment plans are available upon request up to 36 monthly installments. More info...

Faculty of Business & Media via distance learning

• Doctor Ph.D. Degree

45 ... 72 Academic credits required for this distance learning degree program.

Composition:.

+ 39 Academic credits - Total Quality Management Online + Other additional subjects + 18 Academic credits - Research methodology and final project or thesis.

+ 39 Academic credits: Total Quality Management Online

BIU Earned Credits Credits earned through the completion of academic work at Bircham International University (Reports, Projects and Thesis).

1 BIU Earned Credit = 1 USA Semester Credit (15 hours of learning) = 2 ECTS Credits (30 hours of study). Courses list (each subject accounts for 3 academic credits): You may study any subject as an independent online continuing education course. More info...

Postgraduate level continuing education course. Previous knowledge in this field of study is required.

601TQM - Total Quality - TQ 602TQM - Organizational Administration 603TQM - Measuring Customer Satisfaction 604TQM - Supplier Quality Management 605TQM - Six Sigma Methods 606TQM - Logistics 607TQM - Technological Management 608TQM - Management Information Systems 609TQM - Total Quality Control 610TQM - Process Improvement Management 611TQM - Operations Management 612TQM - Human Resources Management 613TQM - Total Quality Management More info...

Bibliography: Total Quality Management via distance learning The corresponding textbooks are included in the fees. Once the fee has been paid, the books may take between two to five weeks to reach your address. Bircham International University offices may inform you at any time of the status of your books. If the book is in English, the required report must be written in English unless you have requested to write it in other language and have gained Bircham International University authorization. More info... Click here to access the recommended bibliography.

+ Additional courses may be selected from other modules in the Faculty of Business & Media from Bircham International University if required. This selection must be approved by the Distance Learning University Education Board. For example: Industrial Production .

Research work resources and network - Doctor - Total Quality Management:

ABCE - Associação Brasileira de Consultores de Engenharia ABEMEC - Associação de Engenharia Mecânica e Industrial ACE - Association for Consultancy and Engineering AEC - Asociación Española para la Calidad AFM - Advanced Manufacturing Technologies ALTEC - Asociación Latino-Iberoamericana de Gestión Tecnológica y de la Innovación AMCSTI - Réseau des Acteurs des Cultures Scientifique, Technique et Industrielle AMT - Association for Manufacturing Technology ASQ - American Society for Quality BEMA - British Engineering Manufacturers Association EIA - Engineering Industries Association FIM - Fédération des Industries Mécaniques GAMBICA - Association for Instrumentation, Control, Automation and Laboratory Technology IEEE TEMS - Technology and Engineering Management Society NAM - National Association of Manufacturers SME - Society of Manufacturing Engineers More info...

Joining the proper association is the best way to become an updated professional. Bircham International University graduates may join many professional associations. Membership requirements for each association may vary depending on the degree program, specialization and graduate resume en each occasion. BIU can not guarantee membership in all instances. BIU does not intermediate in these procedures. Bircham International University provides a list of available memberships and professional references from each faculty where some BIU graduates may belong. Contact directly the ones you select. More info...

+ 18 Academic credits (Research methodology and final project or thesis. More info... ).

Admission requirements: Doctor - Total Quality Management

Bircham International University distance learning degree admission requirements differ depending upon the Faculty and the major of study. There is no discrimination with respect to race, color, sex, beliefs and/or religion. A minimum of 30% of the total number of credits required by any adult degree program syllabus has to be transferred from previous education and/or validated from professional experience in order to gain admission. A maximum of 20% of the total number of credits required by the distance learning degree program can be transferred from professional and life experience. More info...

Click to Download... Application for Admission

Learning outcomes: Doctor - Total Quality Management

The following learning outcomes are compatible with the European Qualifications Framework (EQF) for lifelong learning and continuing education. The EQF directives facilitate acceptance of this course credits by many higher education institution. These learning outcomes are achieved after completion of this course with a passing grade. Better grades will demonstrate higher analysis, evaluation and critical thinking skills. More info...

EQF LEVEL 6. Advanced knowledge and critical understanding. Outcome resulting from course content assessment and its applicability to problem solving. The student's ability to combine the different parts of the text and to form a new coherent and harmonic final report will determine the critical understanding of the subject and an advanced knowledge of Total Quality Management. The student written report style, content, and structure play an important role in the assessment and applicability of the knowledge about Total Quality Management to different Business & Media decision making scenarios and problem-solving. More info...

EQF LEVEL 7. Advanced knowledge and critical thinking. Outcome resulting from written critical thinking and its applicability to problem solving. The student will contrast and evaluate the learned material with his/her own knowledge and experience to express an opinion about Total Quality Management, to consider the practical application of the key concepts, and to argue the conclusions along the written report. Personal judgments and opinion should be based on sound criteria and must be clearly discussed. More info...

BIU adapts each Distance Learning Higher Education degree program to the needs of each student. More info...

Total Quality Management Online

Recognition - Distance degree programs - More info... Accreditation - Distance Learning University - More info... Degree Legalization - Graduate Services - More info... Acceptance of these Distance Learning Higher Education academic credits is always the prerogative of the receiving institution or employer. Recognition criteria differ depending on each educational institution, or company policy, or country legal framework.

QIP IIT INDORE

Quality Improvement Programme

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Abhinandan Bhavan

Digital classroom, about qip centre @ iit indore.

The Government of India launched the Quality improvement Programme in the year 1970. One of the main objectives of the programme is to upgrade the expertise and capabilities of the faculty members of the degree level institutions in the country. The programme is now being implemented and monitored by All India Council for Technical Education. In “Quality Improvement Programme” only sponsored teachers are eligible for admission to both Master’s & Doctoral Degree Programmes, with the aim to enable the teachers to acquire Master’s & Doctoral degrees and imbibe in them a culture of research and better teaching educational capabilities by exposing them to the environment of the institutes of study.

QIP Centre at IIT Indore was established in the year 2018-19 for the fulfillment of the objectives of the QIP scheme like quality, relevance, excellence and equity in technical education in the country. The QIP Centre, IIT Indore currently offers admission to PhD program in 11 different departments which includes Computer Science and Engineering (CSE), Electrical Engineering (EE), Mechanical Engineering (ME), Civil Engineering (CE) and Biosciences and Biomedical Engineering (BSBE), Metallurgy Engineering and Materials Science (MEMS), Astronomy Astrophysics and Space Engineering (AASE), Humanities and Social Sciences (HSS), Physics, Chemistry, Mathematics departments. Under this program faculty members from different engineering institutions have got registered during the year 2020-21, 2021-22 & 2022-23. Apart from this, the QIP Centre, IIT Indore also organizes short-term courses for the faculty members of the engineering institutions coming under the umbrella of AICTE. These courses open avenues in which the faculty members with rich experience in new and upcoming areas share their expertise with the teachers of the QIP institutes.

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63 Universities in the USA offering Postgraduate Quality Management degrees and courses

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Are you looking for Postgraduate courses in Quality Management? Here you can find course providers offering full-time, part-time, online or distance learning options.

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California State University Northridge

University of north carolina wilmington, middle tennessee state university.

Florida Institute of Technology

THE World Ranking: 801

The University of Arizona

THE World Ranking: 155

Catholic University of America

THE World Ranking: 601

Illinois Institute of Technology

THE World Ranking: 351

Saint Louis University

THE World Ranking: 401

George Washington University

THE World Ranking: 201

University of Central Missouri

Bowling Green State University

THE World Ranking: 1001

Suffolk University

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Quality Management Maturity: The Strategic Vision for Biopharmaceutical Excellence

To meet the biopharmaceutical industry’s duty to manufacture safe and effective therapies for patients, a robust quality system is fundamental to success. A quality system should link to quality culture and prioritize focusing on quality, led by management, that fosters sustainable compliance and consistent production of high-quality drugs. Strong quality culture attributes include a proactive and vigilant approach that is science and risk-based, incorporating continuous improvement.

Quality management in biopharmaceuticals has emphasized compliance and control – which is expected given the highly regulated nature of the industry. However, quality management is most effective when it is intentionally designed into every facet of production, shifting the mindset from reactive measures to proactive excellence.

Quality management maturity is a hot topic in the pharmaceutical industry, triggered by the US Food and Drug Administration’s (US FDA’s) creation of a program to promote quality management maturity (QMM) at drug manufacturing establishments. This initiative provides regulatory incentives for organizations to extend beyond current good manufacturing practice (CGMP) requirements to support a more reliable drug supply chain, reduce quality failures, and foster proactive continual improvement. The US FDA’s Center for Drug Evaluation and Research (CDER) has established principles of quality management that are pertinent to all biomanufacturing facilities, especially for biological products with the increased scale of commercial manufacturing. To complement the FDA’s QMM program, several industry bodies have developed industry-led approaches to continuous improvement in quality management, including ISPE’s Advancing Pharmaceutical Quality (APQ) program.

At the 2024 ISPE Biotechnology Conference , Track 2 will serve as a platform for exploring “Quality Culture within the Quality Management Maturity (QMM) Framework” within the industry and the ways regulators envision a future in which quality is not just a compliance requirement, but a driver for more reliable supply of safe and effective drugs for patients, instilled across all facets of daily operations.

Speakers and related sessions include:

Commitment to Quality Through Management Maturity

Presented by: 

Jahanvi Miller

This session will provide a deep dive into the concepts proposed by the US FDA. Miller will focus on the practice areas highlighted in the US FDA’s QMM prototype. This integrates an ICH-based framework to support the industry’s assessment and positively impact overall performance.

Enterprise Maturity

Marla A. Phillips, PhD

Explore an example of the QMM model that involves the delineation of interdependencies across leadership ability, systems, risk integration, and design quality.

Quality Culture in the Pharmaceutical Industry

Investigate the impact of poor quality culture on the safety and integrity of manufactured products. Apply strategies to implement an improved quality culture throughout the organization at a behavioral level.

Quality Maturity Model Framework Construction is an Art

Bright S. Gnanaselvam

Understand the importance of having the right foundation for quality maturity. This session will focus on key fundamentals of a quality management system and the relationship between leadership commitment and quality culture.

A Scientific Perspective on Quality Management Maturity

Thomas Friedli, PhD

Matteo BERNASCONI

Results from a two-year study will be showcased in this presentation, which will focus on the role of leadership in shaping a quality culture and the elements characterizing a good quality culture. Presenters will compare regulatory expectations with the industry’s current understanding.

The Role of Leaders in Quality Culture

Christine Teipen Smith

Smith will provide examples of how leaders implement quality management system program elements and exhibit behaviors that support robust quality culture throughout the rest of the organization.

ISPE Advancing Pharmaceutical Quality (APQ) Program

Ta will present an overview of the APQ program—its basis in ICH Q10, the assess, aspire, act, advance framework, and the guide series. The ISPE APQ program aligns with international ICH Q10 standards and provides a practical framework for organizations to enhance the effectiveness of their pharmaceutical quality system (PQS). It is an industry-led initiative that complements the US FDA’s vision and empowers companies to assess, aspire, act, and advance their level of quality management maturity.

Ta’s 15-minute session will serve as a precursor to a related ISPE training course for those seeking to deepen their understanding and application of QMM principles. The Advancing Pharmaceutical Quality (APQ) Quality Management Maturity Training Course will take place directly following the conference, 19-20 June. The course guides participants through structured tools using industry best practices for assessing and advancing quality within their organizations. 

The Track 2 leads and the extended 2024 ISPE Biotechnology Conference International Program Committee look forward to a thought-provoking and inspiring discussion on QMM at the 2024 ISPE Biotechnology Conference in Boston, Massachusetts, USA, June 17-18.

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Stability sampling and testing are key to ensuring that products maintain safety, identity, strength, purity, and quality throughout their claimed shelf life. It is also a regulatory requirement per ICH Q5. However, storing product samples in different environmental conditions, testing those samples for three to five years (or more) after initial manufacture, and properly analyzing and...

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NewSTEPs Quality Improvement Projects Collaborative Showcase Series: Part 5

The NewSTEPs Quality Improvement (QI) Projects Collaborative Showcase Series features multiple QI projects successfully completed across various newborn screening programs as part of the QI Projects Collaborative. These sessions provide valuable lessons learned during their journey, fostering a dynamic environment for questions and discussion. 

April 11 | Session Five

• New York's Submitter Quality Assurance (QA) and education project
• Tennessee's second-tier CAH project
• Ashley Comer, Senior Specialist, Association of Public Health Laboratories
• Kathy Chou, PhD, Director External Systems Quality, New York State Department of Health
• Gwen McKee, Tandem Mass Manager Newborn Screening, Tennessee Department of Health 

Webinars in this Series

February 8, 2024 - 12:00pm NewSTEPs Quality Improvement Projects Collaborative Showcase Series: Part 1

March 8, 2024 - 12:00pm NewSTEPs Quality Improvement Projects Collaborative Showcase Series: Part 2

March 20, 2024 - 12:00pm NewSTEPs Quality Improvement Projects Collaborative Showcase Series: Part 3

April 4, 2024 - 12:00pm NewSTEPs Quality Improvement Projects Collaborative Showcase Series: Part 4

April 23, 2024 - 12:00pm NewSTEPs Quality Improvement Projects Collaborative Showcase Series: Part 6

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