SQA Quality College

Virtual Courses held 15-26 September 2025

Speaker Information

Barb Munch

Barb Munch is Principal, Munch GLP Consulting, LLC. Barb was formerly Director, R&D Pharma GLP Risk Coordinator, in GlaxoSmithKline (US, UK). Based on her 46-year career and knowledge of toxicology processes and GLP regulations, and the history of why the GLP regulations were written, she provides interpretation of difficult regulatory issues. Barb has been a member of the Society of Quality Assurance since 1991, is a past member of the Board of Directors, and was awarded the John D. Yergler Memorial Award in 2022. Ms. Munch earned her Bachelor of Science degree in Animal Science from the University of Maryland, College Park. She represents SQA members on the OECD GLP Discussion Group.

Ed Armstrong

Edward has over 25 years of compliance experience with small & large molecules, medical device, biotech, and cell & gene therapies. He is resourceful, imaginative, and dynamic leader and team builder. Edward is recognized in the industry for knowledge and understanding of Quality / Regulatory trends and a pragmatic common-sense approach to quality and compliance.

Dawn Niccum

Dawn Niccum is the Executive Vice President of QA and Compliance at the inSeption Group, where she is responsible for all quality and compliance areas for the company including SOP development, Deviation & CAPA management, oversight of computer system validation, audit conduct and support, and GCP training. Ms. Niccum has worked in the pharmaceutical industry and with clinical trials for more than 30 years. Starting as a clinical study coordinator, she then moved to monitoring followed by training and compliance. Ms. Niccum holds a master’s degrees in nursing education and regulatory affairs and quality compliance, holds certifications as a Clinical Research Associate (CCRA), Registered Quality Assurance Professional – GCP (RQAP-GCP) and Project Manager (PMP), and is a registered nurse.

David Glasgow

David Glasgow is the deputy program director of the Office of Bioresearch Monitoring Inspectorate, Office of Inspections and Investigations, FDA. He has been with FDA for over 38 years. He has served in six field districts and headquarters as an investigator, supervisor and manager.

Anthony Jones

Tony Jones is Vice President, Corporate Quality for Syneos Health where he has responsibility for the Quality Optimization Management team. Tony has over 30 years of experience in the healthcare and pharmaceutical industries, encompassing clinical chemistry, pharmacokinetics, clinical research, bioanalysis and Quality Assurance. He worked in biopharmaceutics and clinical research positions for large and mid-sized pharmaceutical companies in England and France prior to moving into a Quality Assurance role for a legacy Syneos Health company in 2000.

Tony enjoys training and publishing on topics related to quality, professional development, bioanalysis/pharmacokinetics and modernizing QA. He has been engaged in the Quality Assurance profession in various forums, for example as Co-Editor of Wiley’s The Quality Assurance Journal with Rita Hattemer-Apostel, Chair of SQA’s Bioanalytical Specialty Section and a regular contributor to the SQA Quality College.

Rita Hattemer-Apostel

Rita Hattemer-Apostel is an accomplished expert in Quality Management and GXP compliance. As an international QM consultant and fractional Chief Quality Officer/Head of QM for 25+ years, she has been instrumental in setting up practical and compliant QM systems for pharma, biotechs and service providers. 750+ audits performed globally in drug development provide her with a unique and broad expert knowledge. Rita has a Masters in Physics Engineering, studied languages, system dynamics and systems thinking and is a certified Coach. She has a particular interest in psychology and linguistics. Rita Hattemer-Apostel has published several book charters and articles on QM topics and been the Editor-in-Chief of the Quality Assurance Journal (QAJ) and the Journal on Pharmaceutical Medicine and Quality Management (PM|QM).

Catherine Bens

Cat Bens provides Quality Assurance and Management consulting services in support of a wide variety of regulated research. Specializing in implementing the Good Laboratory Practices within university, NGO and private non-clinical environments. She assists researchers in meeting research quality requirements through

• Designing and developing quality management systems, including SOP development, equipment and personnel record management, data governance systems, etc. that meet researcher and individual laboratory requirements as appropriate
• Providing quality system training and inspection readiness preparation to meet quality regulations, contractual requirements, and institutional policies and procedures;
• Providing quality assurance inspection and auditing services to facilities needing independent inspection and reporting; and
• Partnering with research and management to develop a culture and understanding of quality and integrity in science; and
• Assisting in hosting federal inspector and sponsor quality and vendor qualification inspection.

Cheryl McCarthy

Cheryl McCarthy, RQAP-GCP, has over 25 years in the industry working for CROs and Sponsors supporting compliance and quality efforts. She is currently consulting and is the Principal/Owner at ANCHOR QA, LLC. Her industry experience includes Development and Management of Quality Management Systems: Establishing and Executing Audit and Inspection Programs; Quality and Compliance support for GCP, GLP and GVP; Establishing and Executing Training Programs; Data Integrity assessments; and Computer System Validation efforts. She is one of the Editors In Chief of SQA’s publication: Data Integrity: The Science, The Regulation, The Use. Her personal passion is teaching, and she actively participates in industry events speaking on GCP and other Quality and Compliance Topics.

Joseph Franchetti

Since 2001, Joe Franchetti has served as the CEO and President of JAF Consulting Incorporated, establishing himself as a leading authority in Digital Transformation, Data Integrity, 21 CFR Part 11, Annex 11, HIPAA, and Computer System Validation across regulated sectors such as Healthcare, Pharmaceuticals, Life Sciences, Cannabis, Nutraceuticals, and Medical Devices.

With over 30 years of experience in developing, procuring, implementing, auditing, and maintaining computerized systems for regulated organizations, Joe is recognized for driving strategic initiatives that enhance operational efficiency and regulatory compliance. Under his leadership, JAF Consulting has spearheaded numerous key projects, successfully transforming clients' approaches to compliance and data integrity. These projects often involve complex, global regulatory environments, showcasing Joe’s expertise in navigating both U.S. and international regulations, including GLP, GMP, GCP, ISO, and Sarbanes-Oxley (SOX) standards.

Beyond his technical expertise, Joe brings over 35 years of progressive leadership in Quality Assurance, Information Technology, and Data Management. His critical thinking and innovative mindset have been instrumental in developing advanced digital solutions that meet the evolving needs of the life sciences industry. He has played a key role in integrating cloud computing, artificial intelligence, and advanced data systems for clients, ensuring compliance while leveraging the latest technological advancements.  

As a recognized thought leader, Joe is frequently sought for his insights on regulatory compliance, quality assurance, and computer systems validation. He has been an active contributor to prominent industry groups, including the Society of Quality Assurance (SQA), the International Society for Pharmaceutical Engineering (ISPE), and the Drug Information Association (DIA).

Joe currently serves as the Immediate Past President of the Society of Quality Assurance (SQA), where he has held numerous leadership positions over the past 23 years. These roles include Chair of the Computer Validation & Information Technology Compliance (CVIC) Specialty Section, overseeing critical training programs on Data Integrity and Computer Systems Validation. He is also a Past Chair of both the SQA Education Committee and the Quality Assurance Consulting Support Specialty Section. Recognized as a Distinguished Speaker by the SQA Learning Foundation since 2017, he has contributed to workshops and conferences worldwide. Additionally, Joe was one of the editors-in-chief of the book Data Integrity: The Science, The Regulations, The Use (Edition 01, released March 2025).  

Throughout his career, Joe has worked on projects spanning the globe, managing regulatory compliance efforts across multiple countries and ensuring alignment with international standards, including those of the European Union and Japan's Ministry of Health, Labor, and Welfare. His expertise extends well beyond cloud computing, disaster recovery/business continuity, vendor/supplier audits, and quality systems implementation. His efforts have led to significant improvements in data management, electronic records, and laboratory operations, including robotics and informatics for drug discovery.

As a mentor and advocate for professional development, Joe has played a pivotal role in training and guiding the next generation of quality assurance and regulatory professionals. His commitment to education and talent development is evident through his leadership in instructional design and ongoing mentorship of rising professionals in the field.

Joe’s global impact, combined with his strategic leadership, innovation, and dedication to advancing regulatory compliance and digital transformation, has solidified his reputation as a respected figure in the industry, continually shaping the future of regulated environments.

Mojisola Komolafe

Mojisola Komolafe is a results-driven Process Improvement Specialist with a proven track record of optimizing business operations, enhancing efficiency, and driving continuous improvement across various industries. With extensive experience in lean methodologies, Six Sigma, and process reengineering, she has successfully led transformational initiatives that reduce waste, improve productivity, and enhance overall organizational performance.

Mojisola has worked with various public and corporate organizations to identify inefficiencies, streamline workflows, and implement data-driven solutions. She is skilled in conducting gap analysis, developing standard operating procedures (SOPs), and fostering a culture of continuous improvement through employee engagement and leadership training.

Her expertise spans process mapping, root cause analysis, performance benchmarking, and the implementation of key performance indicators (KPIs) to measure and sustain operational gains. She is passionate about leveraging technology and best practices to drive sustainable business success. Mojisola holds a Masters degree in Organizational Behavior, and a Bachelor’s degree in Business Administration. She is a certified ISO 9001 QMS and ISO 21001 EOMS Auditor. A Certified Project Manager (PMI USA & Prince 2 UK) and a certified lean Six Sigma Black Belt.

Nene Oche

Nene Oche is Founder and Lead Consultant at QBS Global, the trade name of Quality First Business Solutions Nigeria Limited, a healthcare quality management consulting firm with regional impact across Africa. With over 25 years of experience backing the organization’s roots, Nene leads its mission to transform healthcare systems by advancing the implementation of international quality standards, including ISO 15189, ISO 7101, ISO 9001, ISQua EEA Accredited standards, etc, especially in resource-constrained environments. Her expertise spans quality management systems, laboratory accreditation, systems optimization, and healthcare capacity building. She has developed and delivered specialized training programs for clinicians, laboratory professionals, and healthcare organizations across Nigeria, Ghana, Kenya, Malawi, and South Africa. Passionate about excellence and impact, Nene holds professional affiliations and leadership roles in several strategic initiatives within Africa and globally.

Barb Munch

Barb Munch is Principal, Munch GLP Consulting, LLC. Barb was formerly Director, R&D Pharma GLP Risk Coordinator, in GlaxoSmithKline (US, UK). Based on her 46-year career and knowledge of toxicology processes and GLP regulations, and the history of why the GLP regulations were written, she provides interpretation of difficult regulatory issues. Barb has been a member of the Society of Quality Assurance since 1991, is a past member of the Board of Directors, and was awarded the John D. Yergler Memorial Award in 2022. Ms. Munch earned her Bachelor of Science degree in Animal Science from the University of Maryland, College Park. She represents SQA members on the OECD GLP Discussion Group.

Stephen Rogenthien

Stephen Rogenthien, RQAP-GLP, is currently a Senior Director of Quality Assurance providing compliance leadership and mentorship to Altasciences. Prior to his current position, Mr. Rogenthien served as Senior Director of Quality Assurance for Concord Biosciences/Ricerca Biosciences, where he oversaw the quality programs that supported the company's drug safety & metabolism, bioanalytical, chemical development, and agrochemical product development departments. Mr. Rogenthien also served as the Director of Quality Assurance for Oneida Research Services/Prevalere Life Sciences where he oversaw the quality programs that supported the company's bioanalytical, biotechnology, and analytical chemistry groups. He is a Past President of SQA, and previously served two terms as director on the SQA Board of Directors, three years on the SQA Education Committee, and three years as chairman of the Bioanalytical Specialty Section.

Greg Furrow

Greg Furrow is currently Chief Quality Officer at Mustang Bio, Inc. a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases. He began his career at the University of Maryland and the USDA before joining Eli Lilly and Company as an analytical chemist. While at Lilly, he held positions in Analytical Development Research, Parenteral Cephalosporin Manufacturing Administration, Quality Control and Analytical Laboratory Management, Human Resources and Quality Assurance Management. He was at Lilly for 21 years before joining Charles River where he was Sr. Director of Regulatory Affairs and Compliance for 5 years. In 2011, Greg joined the WIL Research Company where he was Vice President of Quality and Regulatory Compliance. After leaving WIL, he went to Southern Research as VP of Quality and Compliance where he was responsible for QA, EH&S, biosafety, ISO 9000 Quality Management, Export Control, Government Security, Human Resources and IT. Greg has degrees in Chemistry and Analytical Chemistry from the University of Maryland and is an SQA director, past president of SQA, past SQA treasurer and, SQA Regulatory Communications Coordinator and SQA’s EPA representative on the OECD GLP discussion group.

Bernadette Bowen

Bernadette Bowen has been in the biopharmaceutical industry for over 25 years in the therapeutic areas of Oncology, Gastroenterology and Endocrinology. Bernadette is an initiative-taking Quality professional with a solid knowledge base in Good Clinical Practice and Good Pharmacovigilance Practice. She is a results-oriented team player with a focus on quality and compliance. Bernadette started her Quality career in 2010 with Clinical Quality Assurance and Quality Systems, working for both small and large companies such as Rhythm Pharmaceuticals, Mustang Bio, Ironwood Pharmaceuticals, Takeda Pharmaceuticals, and Millennium Pharmaceuticals. Prior to her career in Quality, Bernadette worked in Regulatory Affairs for Millennium Pharmaceuticals and Parexel International.

Leslie Paul

Former FDA Investigator with over 30 years of experience in the FDA-regulated industry. Extensive experience in drug, medical device, and bioresearch monitoring program inspections. Prior experience in drug discovery, R&D, product development, clinical trials, quality assurance, and auditing. Champions cross-functional and virtual teams to establish and improve quality compliance systems and programs, including quality governance programs, internal, supplier, and clinical QA audit programs, inspection readiness, regulatory landscape monitoring, and GxP training.

Dawn Niccum

Dawn Niccum is the Executive Vice President of QA and Compliance at the inSeption Group, where she is responsible for all quality and compliance areas for the company including SOP development, Deviation & CAPA management, oversight of computer system validation, audit conduct and support, and GCP training. Ms. Niccum has worked in the pharmaceutical industry and with clinical trials for more than 30 years. Starting as a clinical study coordinator, she then moved to monitoring followed by training and compliance. Ms. Niccum holds a master’s degrees in nursing education and regulatory affairs and quality compliance, holds certifications as a Clinical Research Associate (CCRA), Registered Quality Assurance Professional – GCP (RQAP-GCP) and Project Manager (PMP), and is a registered nurse.

Barb Munch

Barb Munch is Principal, Munch GLP Consulting, LLC. Barb was formerly Director, R&D Pharma GLP Risk Coordinator, in GlaxoSmithKline (US, UK). Based on her 46-year career and knowledge of toxicology processes and GLP regulations, and the history of why the GLP regulations were written, she provides interpretation of difficult regulatory issues. Barb has been a member of the Society of Quality Assurance since 1991, is a past member of the Board of Directors, and was awarded the John D. Yergler Memorial Award in 2022. Ms. Munch earned her Bachelor of Science degree in Animal Science from the University of Maryland, College Park. She represents SQA members on the OECD GLP Discussion Group.

Lori Wright

Lori Wright, RQAP-GLP is the Senior Director, Quality Assurance at Inotiv. She is responsible for the effective operation of QA teams at regulated sites and for serving as an influential leader of Inotiv’s Discovery and Safety Assessment organization. Lori has served in leadership roles at StageBio, Southern Research, Charles River, and WIL Research and has over 30 years of GLP experience. She is an active Society of Quality Assurance (SQA) member and is the 2025 SQA President. She has served as chair of the SQA GLP Specialty Section, chair of the Education Committee, President of the Southern Regional Chapter of SQA, and various other elected and volunteer positions. She is an SQA Distinguished Speaker and a frequent presenter at SQA national and regional chapter events. Lori is a Registered Quality Assurance Professional in GLPs and a Lean Six Sigma Green Belt.

Gina Tucker

Gina M. Tucker, MBA, RQAP-GLP is a Senior Compliance Consultant with JAF Consulting, Inc.. Ms. Tucker received her Bachelor of Science from Mount St. Mary’s College and Master of Business Administration degree from Mount St. Mary’s University. She joined JAF Consulting, Inc. in 2022. She has over 18 years’ experience in a global regulated environment, primarily in quality assurance and computer system validation. Ms. Tucker has GLP auditing experience including, but not limited to, toxicology, pathology, method validation, and studies related to the Animal Rule. Ms. Tucker has presented several topics related to computer system validation and GLPs at SQA Annual Meetings

Charles Burt

Charles Burt is a Sr Quality Manager in charge of the supplier and raw materials program at Abeona. He has background experience in CGT, IVDR and Medical Device manufacturing.

Ben Podany

Ben Podany, CQA is currently serving as a Quality Assurance Manager at Abeona Therapeutics in Cleveland, OH. Ben has spent eleven years working in FDA regulated industries with his current focus on designing, implementing, and maintaining a quality management system to ensure compliance with FDA regulations and drive continuous improvement.

Scott Arnott

Scott Arnott is the Associate Director of the Quality Assurance Department within Abeona Therapeutics. The QA group consists of 5 subgroups including: Quality Operations, Quality Systems, Supplier Quality, Clinical/Non-Clinical Quality, and Investigations/Quality Records Management. Scott has 10+ years of FDA regulated industry experience working in various roles within quality control and quality assurance.

Vanessa Dubay

Vanessa M. Dubay, RQAP is Senior QA Compliance Auditor with Labcorp Bedford, a pre-clinical medical device testing laboratory accredited to ISO 17025. Vanessa has worked in quality assurance for over 8 years and is currently focused on hosting sponsor audits and regulatory inspections, as well as coordinating quality management systems activities such as internal audits. She is the current president of the New England Regional Chapter of SQA (NERCSQA). Vanessa has a degree in chemistry from the University of Massachusetts, Boston.

F. Randi LaMadeleine

Randi LaMadeleine, RQAP-GLP is the QA Manager for Labcorp's Bedford site and oversees the quality assurance auditors. The team supports testing of medical devices under the GLPs and ISO 17025 Quality System. For the past 25 years, Ms. LaMadeleine has worked as a member QAU for a contract research organization. Previously to her role as QAU, she spent 8 years in R&D, with the majority of that time on medical device testing. Ms. LaMadeleine has her Bachelors in Biochemistry/Chemistry.

Pam Dellea-Giltner

Pam Dellea-Giltner started her involvement in Clinical Research in 1991 working in pharma in various positions including Clinical Quality Auditing, Phase IV Clinical Research studies in several therapeutic areas, Health Outcomes Research, and Medical Affairs. She also has held positions in both small and large CRO’s then decided to become an independent consultant in 2015. While early consulting positions were more in Clinical Research areas, Clinical Quality Auditing has become her focus again with experience with Investigator Site audits, Vendor audits, Document audits, technical writing, and process audits in all areas of Clinical Research. In addition to conducting training presentations in several areas of Clinical Auditing at both SQA Quality College and Global meetings, she is chair of the Quality Assurance Consulting (QACS) Specialty Section for 2025 along with being an active member of several SQA committees. Pam received a BS in Pharmacology, an MBA in Pharmaceutical Marketing and received her RQAP-GCP certification in 2021.

Kamila Novak

Kamila Novak, MSc in molecular genetics, has been involved in clinical research since 1995, working in various positions in pharma and CROs. Since 2010, she started working as a contractor and incorporated several years later. Her business activities include auditing, consulting for QMS establishment, clinical risk management, and process improvements, training, and medical writing. Kamila is a certified Lead Auditor for five ISO standards and a certified auditor for two more. She is an active member of the DIA, the SQA the CDISC, the Florence Healthcare Site Enablement League, and other professional organisations. She publishes articles, speaks at webinars and conferences. She and her company actively support capacity building programs, access to healthcare and education in Africa

Tina Yanchis-Kirby

Tina Yanchis-Kirby, MS, RQAP-GLP, serves as the Quality Manager at the Animal Health Diagnostic Center within the College of Veterinary Medicine at Cornell University. With a strong foundation in Good Laboratory Practice (GLP) compliance, Ms. Yanchis-Kirby has dedicated the majority of her career to ensuring rigorous quality standards in laboratory environments. In her current role, she oversees adherence to ISO/IEC 17025 requirements, playing a key role in maintaining the center’s accreditations and operational excellence. She holds both a Bachelor of Science and a Master of Science in Biology, and is a certified Registered Quality Assurance Professional in Good Laboratory Practices.

Nene Oche

Nene Oche is Founder and Lead Consultant at QBS Global, the trade name of Quality First Business Solutions Nigeria Limited, a healthcare quality management consulting firm with regional impact across Africa. With over 25 years of experience backing the organization’s roots, Nene leads its mission to transform healthcare systems by advancing the implementation of international quality standards, including ISO 15189, ISO 7101, ISO 9001, ISQua EEA Accredited standards, etc, especially in resource-constrained environments. Her expertise spans quality management systems, laboratory accreditation, systems optimization, and healthcare capacity building. She has developed and delivered specialized training programs for clinicians, laboratory professionals, and healthcare organizations across Nigeria, Ghana, Kenya, Malawi, and South Africa. Passionate about excellence and impact, Nene holds professional affiliations and leadership roles in several strategic initiatives within Africa and globally.

Shane Comiskey

Shane Comiskey holds MSc in Biotechnology and in software development. He has over 24 years of experience in quality and compliance related oversight, including Computer System Validation (CSV), Good Pharmacovigilance Practice (GVP), Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP) and Good Manufacturing Practice (GMP) as well as a large experience in auditing validated computer systems, Data Management, Biostats, suppliers and investigator sites. He is experienced in the management of audit teams and compliance oversight of investigational product development programs.