SQA Quality College

Virtual Courses held 16-30 September 2024

 

Speaker Information

 

Anthony Jones

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Presenter for:
GEN 111 — Critical Thinking by Design 

Bio: 
Tony Jones is Vice President, Quality Assurance for Syneos Health where he has responsibility for the company’s global QA 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, Chair of SQA’s Bioanalytical Specialty Section and a regular contributor to the SQA Quality College.

Rita Hattemer-Apostel

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Presenter for:
GEN 111 — Critical Thinking by Design 

Bio: 
Rita Hattemer-Apostel is a seasoned quality management expert in drug development / GXP / clinical research, with 30+ years experience in pharma, CROs and as a consultant for more than 20 years. This includes GCP auditing  of trials and systems (international), developing customized trainings, and consulting in QM for pharma and biotech companies, mostly at the stage of starting clinical development. Rita has expert knowledge in regulatory requirements related to drug development with a focus on the clinical phase, excellent analytical skills to analyze processes and proven coaching skills. Rita Hattemer-Apostel has a Masters in Physics Engineering), Certified Quality Manager (RWTÜV), and is a certified Coach. She has a passion for writing and publishing and has been/is Editor-in-Chief of the 'Quality Assurance Journal' (2000-2011) and 'Pharmazeutische Medizin | Qualitätsmanagement' (since 2022).

 

Jacqueline Torfin

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Presenter for:
GEN 216 — A Compliance Tool You Can Personalize and Implement
GLP 205 — Moving GLP Compliance from Paper to Digital 

Bio: 
Jackie Torfin has been a leader in MedTech and Biotech companies for 30+ years. She has had roles in quality, regulatory, pre-clinical and clinical compliance. She has a BS in Medical Technology, a Master's in Leadership, and has been Adjunct Faculty for 12 years at St. Cloud University in the Master's in Medical Technology Quality and Regulatory Science Programs. 

Jackie is CEO and Principal Advisor at QLeaR Advisors, a consulting firm focused on quality and regulatory compliance for MedTech and Biotech companies.  She supports start-ups and emerging clients in understanding and being compliant to the maze of regulations. 

When not working, she and her husband and two dogs enjoy spending time at their cabin in northern Minnesota and with their family of six children and six grandchildren.

 

Mojisola Komolafe

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Presenter for:
GEN 217— Essentials of Change Management

Bio: 
Moji is a seasoned Business Consultant with over 13 years of experience in management consulting. She has a keen eye for detail and a robust methodology for identifying and mitigating risk. Her proven track record in implementing business strategies, combined with strong leadership skills, has consistently resulted in improved operational efficiency and compliance. Moji is passionate about helping businesses enhance processes and equipping organizations and individuals with the skills to sustain improvements.

Over the past 10 years, Moji has facilitated numerous training sessions, engaged hundreds of delegates in capacity building, and provided coaching as needed. She is a PECB-trained and certified QMS 9001:2015 Lead Auditor and EOMS 21001:2018 Lead Auditor, a Certified Project Manager and member of PMI USA and APMG UK, a PECB-certified Trainer, an APMG-certified Facilitator, and a certified member of the Chartered Institute of Personnel Management (CIPM).

Nene Oche

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Presenter for:
GEN 217— Essentials of Change Management

Bio: 
Nene Oche is a Management Systems Consultant, the Lead Consultant, and Managing Director of Quality First Business Solutions Nigeria Limited. With 18 years in the Nigerian healthcare industry and over 13 years in Quality Management, she specializes in implementing and auditing management systems, operations, and processes in alignment with ISO 9001, 15189, and related standards. Nene has successfully led teams and helped organizations achieve ISO 15189 accreditations and consistent re-accreditations. A Certified Business Development Service Provider and Management Consultant, Nene holds degrees in Microbiology and Applied Biosciences and is pursuing a Master's in International Health Management.

 

Cathy Liu

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Presenter for:
GCP 209 — Inspection Management: Risk-based Clinical Trial Site Inspection by NMPA (Chinese HA)

Bio: 
Cathy Liu leads the Fortrea CDCS Regulatory Compliance & Quality Assurance team in the APAC region (ex-India). She has over 25 years of experience in the pharmaceutical industry and served in multiple roles in MNCs with increasing responsibilities in Clinical Operations, Project Management, Quality Management, Quality Assurance and Quality Strategy.

Cathy actively shares global experience and works with peer company contacts within the region in order to promote GxP standards and influence Quality framework within the region. She is a core team member of China Quality Assurance forum (CQAF) and served as the chairperson in the term of 2018-2020. 

Cathy has a Master's in Business Administration and a Bachelor of Pharmaceutical Engineering.

Hannah Chen

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Presenter for:
GCP 209 — Inspection Management: Risk-based Clinical Trial Site Inspection by NMPA (Chinese HA)

Bio: 
Hannah Chen is a Sr. QA Consultant. She is the founder of China QA Forum (CQAF). She has worked for pharmaceutical industry for more than 20 years, including clinical operations, training, GCP audit and clinical QMS. She started GCP audits in 2003, and hosted inspections from US FDA, EMA, China NMPA and some Asian countries. She attended China NMPA inspectors' training provided by US FDA and WHO as training assistant during 2009-2012, and was one of the members of China 2020 GCP revision experts working group. Since 2019, Hannah had worked as GCP consultant and has been working for a number of pharmaceutical companies including NMC, start-up, and local companies, providing advice and consultation on clinical QMS, inspection readiness, and GCP audits. 

Sean Xu

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Presenter for:
GCP 209 — Inspection Management: Risk-based Clinical Trial Site Inspection by NMPA (Chinese HA)

Bio: 
Sean Xu is Managing Director of Hannah and Associates. This company provides quality assurance consulting services in GCP/GCLP/GLP areas. His 21-year career has been in research and development. Five (5) of those years have been in Clinical Operations as CRA and PM for global CRO and pharma company, 2 years as Compliance and Training Specialist for global pharma company, and 14 years in Clinical Quality Assurance as clinical auditor, QA manager and QA director for global pharma and medical device companies, global CRO, global QA consulting company and local CRO. Sean has a Bachelor in Clinical Pharmacy, a Master in Project Management and currently studies a Doctor of Business Administration. Sean is the core team member and lead of GCP sub-committee for China QA Forum.

Emma Hu

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Presenter for:
GCP 209 — Inspection Management: Risk-based Clinical Trial Site Inspection by NMPA (Chinese HA)

Bio: 
Emma Hu, M.S., is Head of Clinical Quality Assurance in Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui) which is the leading pharmaceutical company in China. Emma has 18+ years of clinical development experience, mainly in Clinical Quality Assurance arena (14+ years). She specialized in GCP and with exposure to GVP and GCLP areas. Emma holds a Master’s degree of Biochemistry and a Bachelor’s degree in Clinical Medicine.

Theresa Wang

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Presenter for:
GCP 209 — Inspection Management: Risk-based Clinical Trial Site Inspection by NMPA (Chinese HA)

Bio: 
Theresa Wang is currently the clinical quality and compliance director at AstraZeneca R&D China, responsible for GCP compliance. She has over 16 years of experience in clinical industry from site, country and study management, and has led several global pivotal studies from strategy design to trial reporting and inspections. In recent years, Theresa has led a group of clinical quality managers to design and implement quality strategy, supporting teams with over 600 people and covering different therapeutic areas and innovative solutions such as DCT.

 

Aurea Flores

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Presenter for:
GCP 210 — Operational and Compliance Considerations for Investigational Drug Services

Bio: 
Dr. Aurea Flores is a clinical research professional with over 25 years of experience. She is a licensed pharmacist and was awarded a Ph.D. in pharmacology & toxicology with an emphasis on drug metabolism and chemical carcinogenesis. She has conducted/supported clinical trials in a variety of areas (oncology, cardiology, neurology, gastroenterology, bariatrics, pediatrics, and others) with an emphasis on patient safety, operations, quality, and regulatory compliance. She is a Certified Clinical Research Professional (CCRP-SoCRA), Project Management Professional (PMP-PMI), and Agile Project Manager (PMI-ACP), and is Certified in Healthcare Research Compliance (CHRC-HCCA), Certified in Healthcare Compliance (CHC-HCCA), Certified in Health Privacy Compliance (CHPC-HCCA). She is also a Certified Compliance & Ethics Professional (CCEP-SCCE) and a Registered Quality Assurance Professional in Good Clinical Practice (RQAP-GCP/SQA). She is a speaker at national meetings and consults in areas of clinical research operations, project management, healthcare and research compliance, and quality assurance.

 

Sara Rybak

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Presenter for:
GLP 104 — Auditing Techniques 

Bio: 
Sara Rybak BS, RQAP-GLP is the Associate Director of Regulatory Compliance at the Charles River site based in Skokie IL (formerly WIL Research, Midwest BioResearch). In this position she manages a team of auditors who regularly perform audits of genetic toxicology and large molecule bioanalytical GLP and clinical studies, computer system validation packages and facilities. Previous to her role in management, she spent 9 years as an auditor, and worked in a GMP laboratory at Abbott Laboratories supporting the diagnostic division. Sara holds a BS in Chemistry.

Gina Tucker

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Presenter for:
GLP 104 — Auditing Techniques 

Bio: 
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 17 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.

 

Greg Furrow

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Presenter for:
GLP 106 — FDA GLP Preamble Overview 

Bio: 
Greg Furrow has held either QC laboratory, QC, QA or Senior Quality management positions for over 35 years. He’s been in sponsor companies (Eli Lilly and Company and Mustang Bio. Inc.) and contract research organizations (Charles River, WIL Research and Southern Research) and is currently Chief Quality Officer and manufacturing site head 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 is a past president of the Society of Quality Assurance (SQA) and has also held the roles of SQA director and treasurer. He represents SQA members on the OECD GLP discussion group.

Barbara Munch

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Presenter for:
GLP 106 — FDA GLP Preamble Overview 

Bio: 
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 45-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 is chair of the Histopathology Specialty Section.  Ms. Munch earned her Bachelor of Science degree in Animal Science from the University of Maryland, College Park.

Eric Pittman

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Presenter for:
GLP 106 — FDA GLP Preamble Overview 

Bio: 
Eric Pittman currently serves as the Program Division Director (PDD) for the Bioresearch Monitoring Division II (BIMO-W) staff.  As the PDD, he provides leadership in directing and managing programs and a professional staff in locations from Detroit, MI to Hawaii covering all clinical and non-clinical facilities.  In addition to being the PDD for BIMO-W, Eric is one of the U.S. Representatives to the Organization for Economic Co-Operation and Development (OECD).

Supplement to his work experience with the FDA, Eric has worked in the Medical Device, Food and Drug Industries serving in various capacities such as a Regulatory Affairs Associate and Director of Quality.

Eric attended Purdue University School of Pharmacy and while there also earned a degree in radiation physics. He has an MBA from Youngstown State University along with several certifications for various quality and regulatory activities.

Stephen Rogenthien

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Presenter for:
GLP 106 — FDA GLP Preamble Overview 

Bio: 
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 (2019), 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.

 

Brendan Hyland

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Presenter for:
GLP 205 — Moving GLP Compliance from Paper to Digital

Bio: 
Brendan Hyland, M.Eng., RQAP-GLP, is an independent consultant who helps GLP facilities transform their quality and data systems from time-consuming, deviation-invoking regulatory burdens into the competitive advantage they were meant to be. 

He is a Registered Quality Assurance Professional in GLP with a Master's in Chemical Engineering. Over his 24-year career, he has managed multinational pharmaceutical development projects, run QA departments, developed software for the regulated industry, and even spent several years trying to tame the wild west that is the Canadian cannabis industry.

Mr. Hyland is on a mission to improve how regulated industries approach one of the most well-used data processing tools out there: the spreadsheet!

Jacqueline Torfin

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Presenter for:
GEN 216 — A Compliance Tool You Can Personalize and Implement
GLP 205 — Moving GLP Compliance from Paper to Digital 

Bio: 
Jackie Torfin has been a leader in MedTech and Biotech companies for 30+ years. She has had roles in quality, regulatory, pre-clinical and clinical compliance. She has a BS in Medical Technology, a Master's in Leadership, and has been Adjunct Faculty for 12 years at St. Cloud University in the Master's in Medical Technology Quality and Regulatory Science Programs. 

Jackie is CEO and Principal Advisor at QLeaR Advisors, a consulting firm focused on quality and regulatory compliance for MedTech and Biotech companies.  She supports start-ups and emerging clients in understanding and being compliant to the maze of regulations. 

When not working, she and her husband and two dogs enjoy spending time at their cabin in northern Minnesota and with their family of six children and six grandchildren.

 

Steven Thompson

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Presenter for:
CSV 104 — AI Unleashed: Fun and Exciting Tools, Tips, Tricks, and Techniques for Life Science! 

Bio: 
Steve Thompson has over two decades of experience in Life Sciences, specializing in Technology and Quality Assurance. He is the Founder & CEO of INTEKNIQUE, LLC, an AI technology company dedicated to advancing the Life Sciences industry.

Steve is a certified systems auditor, published author, and frequent speaker at industry conferences. He serves as a Board Director for PRCSQA and sat on Editorial Advisory Boards, as an Elite Faculty member for an industry association, and Adjunct Lecturer at prestigious Universities.

Steve’s achievements include an APEX 2020 award for excellence for co-authoring a peer-reviewed article on Blockchain in Pharmaceutical Engineering, as well as the 2021 Voices In Validation podcast of the year award by the Institute of Validation Technology. 

He is committed to driving ethical advancements in Life Sciences technology, helping organizations harness the benefits of innovation while mitigating inherent risks.

Tommi Papson

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Presenter for:
CSV 104 — AI Unleashed: Fun and Exciting Tools, Tips, Tricks, and Techniques for Life Science! 

Bio: 
Tommi Papson is currently President of Regulatory Consultants Group, serving the international life sciences community. Traveling as a volunteer, mentor and artist, Tommi shares experience and insight. Careers of experience & fun include US FDA Investigator (Retired)- FDA Consumer Safety Officer, International Cadre Team, BIMO, Pharma, Medical Devices, MQSA Auditors, X-Ray and Laser Radiation Inspector, Recall Coordinator Back Up, FEMA Radiation Monitor and Off Site Dose Assessment Officer, US Nuclear Radiation Program. Calif. State Food & Drug Branch Certified Environmental Health Specialist, Inspector, X-ray Auditor, Certified Registered Rad Tech, Nuclear Medicine, Interventional Medicine, California Teaching Credential, Director of Radiology. Continues to enjoy the community of art and science, blending marriage, travel photographer, artist, sculptor and author.

Jacqueline M Bushong

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Presenter for:
CSV 104 — AI Unleashed: Fun and Exciting Tools, Tips, Tricks, and Techniques for Life Science! 

Bio: 
Jackie retired from the pharmaceutical industry after more than 20 years in clinical QA.  She is currently in the SQA Board of Directors and has held various leadership positions within SQA and PRCSQA over her career.  She lives in Grass Lake, MI.