CDR Jeff Yuen is a well-respected domestic and international speaker with over 32 years of compliance and regulatory experience; Jeff was a peace officer/investigator with the State of California, Food and Drug Branch and a Consumer Safety Officer for the US FDA. During his tenure with the US FDA, he was rapidly promoted to the rank of Commander in the US Public Health Service.
Kath is a highly experienced Quality Assurance professional offering consulting and auditing services within the pharmaceutical industry and pharmaceutical research arena. With over 24 years’ experience of working in a pharmaceutical environment, her existing skills set includes auditing in GCP, GVP and clinical / analytical laboratory areas as well as for-cause and due diligence audits. She specializes in conducting GCP inspection readiness activities to assist clients in preparing for EMA and MHRA GCP inspections. In addition, Kath has worked at a strategic level in developing risk-based strategies for QA led initiatives and audit programs as well as departmental and line management responsibilities. She is a former MHRA GCP Senior Inspector with additional experience of working for small, medium and large pharmaceutical companies in a QA environment.
Christine is an experienced Qualified Person (UK) and Quality Assurance Professional and is highly experienced in auditing and working with the Quality Management systems of both EU and non-EU organisations, with an excellent knowledge of EU and EU referenced requirements. She is particularly experienced in understanding and advising on the requirements for complex supply chains and on EU QP Certification of products manufactured outside the EU. Christine is highly experienced in the preparation and review of Pharmaceutical Quality Systems and associated documents such as Technical Agreements and Product Quality Reviews. She is also a proven project manager with experience of clinical trials, product development and manufacturing site transfers.
Nazilla has worked as a clinical consultant with over 24 years of clinical trials experience in project management, QA and GCP/ICH auditing, and team/trials management throughout the United States, Western/Central/Eastern Europe, Australia and Canada. Strong experience managing and auditing trials in oncology, ophthalmology, bariatric surgery, and cardiology; pharmaceutical studies in plastic surgery, hematology, obesity, CNS, smoking cessation, anesthesiology, renal disease/dialysis, hepatology, and uremic pruritis; biologic studies in oncology, rheumatoid arthritis, psoriasis, and hypertrophic scarring.
Laurie is a Results-driven professional with 15 years compliance, project management, and technical expertise in medical device and combination product industry. Skilled auditor conducting over 50 ISO 13485, GMP, EU MDD, EU IVDD, and Health Canada audits and mock inspections. Extensive DHF, Risk Management file and Technical file remediation experience including Combination Product and EU MDR requirements. Specialize in implementing medical device quality management systems for startups and biopharmaceutical companies developing combination products. Product experience includes drug delivery systems (on-body injectors, pre-filled syringes, transdermal patches, autoinjectors, nasal sprays, oral dispensers, applicators), Class III oncology detection systems utilizing LED optical reflectance technology, blood gas and electrolyte analyzers, molecular diagnostic platforms and assays, software as a medical device (SaMD), and other Class I – III consumable and reusable medical devices, IVDs, and combination products with mechanical, electrical, and software components.
Tania has broad regulatory and quality background gained over 25 years in the drug, biologics and medical device industries. She is experienced in strategic and operational management of regulatory activities to support global registrations. Tania has successfully established GMP and GCP systems to support clinical studies of novel invivo medical devices including but not limited to implantables, diagnostics and pre-filled syringes. Finally, she has clinical experience in the development and registration of oncology drugs under accelerated approval processes.
With 30 plus years of biomedical industry experience, Christopher Hartle has been a consultant with JYA since 2009 offering leadership in a wide variety of quality management projects, with a dedicated focus on developing and enhancing quality systems. His expertise includes third-party quality systems evaluations, risk assessments, and thorough compliance audits across all GxP disciplines. Christopher has successfully led efforts in training, project management, change management, and issue resolution. Over the span of his career, he has taken on leadership roles in various biomedical companies, both large and small, where he has overseen QA compliance efforts for multinational Phase III clinical trials, provided support before, during, and after regulatory inspections, and consistently contributed to the development of strong internal quality and compliance cultures. With a Master’s degree in Biomedical Quality Systems, Christopher brings a wealth of knowledge and expertise, making him a valuable resource for organizations seeking regulatory compliance and effective quality management.
Brian has over 30 years of experience in the pharmaceutical industry, including small molecule, biologics, and combination products. His experience includes Quality Management Systems, laboratory quality, manufacturing quality, regulatory compliance, regulatory affairs, controlled substance compliance, API manufacturing, aseptic manufacturing, solid oral dosage manufacturing, stability management and compliance, and direct M&A support activities. Primarily working in the CDMO space, he has directly interacted with over 300 pharmaceutical companies, from small start up companies to some of the largest and most reputable organizations in the world, including AstraZeneca, Lilly, various Johnson & Johnson divisions, Pfizer, and Merck. During his career, he has audited over 200+ facilities in the US, Europe, Asia, South America, Canada, and Africa. He has vast experience providing compliance and regulatory support from early phase product development through full commercialization. He graduated from Carson Newman University in 1986 with a BS in Chemistry, and earned a MBA degree from the University of North Carolina – Wilmington in 2007.
Lori is a former FDA Device Specialist, BIMO investigator, and Drug Team Supervisor. She has 15 years of experience with FDA followed by 6 years consulting in all commodities, drugs, device, and BiMO. Lori has an additional 5 years as a Clinical Quality Associate Director and Senior Quality Director in combination products. Her breadth of experience honed an inspectional technique focused on risk based review with an understanding of the need to focus on issues critical to product quality, data integrity, and subject safety.
Jody Grooms is an accomplished Pharmaceutical Executive that has amassed an impressive track record of successfully building and cultivating mission-driven, cross-functional teams. He has deep expertise in the field of pharmacy compounding, in both the 503A Pharmacy and the 503B Outsourcing Facility industry. He is a graduate of Samford University with a bachelor’s degree in pharmacy. Jody began his career in acute care pharmacy holding a variety of clinical and operational positions in the hospital pharmacy setting. After his career in hospital pharmacy, Jody joined Central Admixture Pharmacy Services, Inc (CAPS) in 1992 at the Birmingham, Alabama location. Having held a variety of leadership positions within CAPS, Jody assumed the role of Vice President of Operations in 2015, and then Corporate Vice President of Operations in 2022. He most recently served as President of the Organization until October 2023. He has dedicated his career to elevating pharmaceutical industry standards while navigating complex regulatory environments. His knowledge and expertise are now being utilized in the area of consulting with emphasis on regulatory compliance and operational excellence.
Jacqueline served with the FDA for 30 years as a Biologics Investigator and 25 of those years as one of the original members of Team Biologics. She retired from the FDA in 2022 as one of the last original members of Team Biologics. She has inspectional experience and regulatory knowledge in Biopharmaceutical product areas of Vaccines, Plasma derived products including their Recombinant analogues, Licensed IVD Products, Chimeric Antigen Receptor-T Cell (CAR-T) Gene and Cell Therapy Products, Human Cells, Tissues and Cellular and Tissue Based Products (HCT/Ps), Antivenins, and Allergenic Extract Products. She has also participated in Remote Regulatory Assessment (RRA) Operations request for records, for domestic and foreign firms for (CBER) Biopharmaceutical and (CDER) Drug Products. She was also active in training FDA personnel and participated in writing guidance for inspectional purposes.
Laura R Diaz-Bao is a proven Pharmaceutical and Biotech Industry professional with vast experience in functions related to Quality Systems like Quality Risk Management , Training, Investigations and Human Error Preventive initiatives with over 28 years of experience in the pharma industry. Broad experience on Process Improvement, Engineering , Project Management and Manufacturing Operations especially in aseptic processes, parenteral, lyophilization, parenteral inspection, packaging processes and drug substance manufacturing. Proven ability leading professional teams , complex projects and developing training structure for start-up and operations. Implemented robust Training and Quality Risk Management Systems achieving sustainable results. Developed Human Performance Evaluation programs to prevent/reduce human errors. Extensive expertise in Quality Investigations, CAPA systems, Remediation initiatives and preparing companies for regulatory inspections. Her experience includes direct management for FDA, COFEPRIS, EMEA, KFDA, PMDA, ANVISA, SFDA , TMMDA , Health Canada, and the Ministry of Health of Russia. Mastery in Diversity & Inclusion initiatives. Laura is an experienced Chemical Engineer from Mayaguez Puerto Rico University and possesses a Master in Food Science from Cornell University, Ithaca New York.
Joy is a new JYA Senior Regulatory and Quality Consultant with 25 years of biopharmaceutical industry expertise in GXP quality assurance and regulatory affairs. Joy brings patient-centric, pragmatic compliance solutions for biopharma clients looking for JYA services such as GCP BIMO Inspection Readiness. She also is a trusted resource for strategic regulatory consulting, writing, and meeting management for IND, NDA, and BLA strategies. She has a broad background as a hands-on quality and regulatory leader on both the Sponsor and Contract Service Provider sides of the business.
Alicia is a regulatory leader, mentor, international collaborator, public speaker/trainer and critical thinker with 25 years of U.S. Food and Drug Administration (FDA) experience in the Office of Regulatory Affairs (ORA) and the Center for Drug Evaluation and Research (CDER). She has extensive knowledge and experience of FDA processes and procedures in both inspections and compliance. While with FDA, Alicia was an instrumental member of the drug cadre training new investigators on drug process inspections. Her inspectional specialities include: sterile (small molecule and biotech products), active pharmaceutical ingredient, topical and solid oral dosage forms. Since her retirement from FDA in 2019, Alicia has been performing mock inspections, supporting sites during on-site FDA inspections, providing guidance on corrective actions and 483 responses and recently serving as an expert witness.
CDR Jeff Yuen is a well-respected domestic and international speaker with over 32 years of compliance and regulatory experience; Jeff was a peace officer/investigator with the State of California, Food and Drug Branch and a Consumer Safety Officer for the US FDA. During his tenure with the US FDA, he was rapidly promoted to the rank of Commander in the US Public Health Service while serving as a member of the following teams:
CDR Yuen served as District Drug Team Leader and Drug Pre-Approval Manager during his time with US FDA. CDR Yuen specialized in both high priority drug (PAI) and biologics (ELA and BLA) inspections. He is widely recognized as a CGMP and compliance expert by industry, CDER and CBER Office of Compliance in the area of sterile drug manufacturing particularly with regard to inspection of biotech products, aseptic filling, quality systems, and process validation.
CDR Yuen is the recipient of numerous US Public Health commendation and achievement medals including a “Hammer Award” presented by Vice President Al Gore’s Office for his participation and leadership in innovative biotechnology.
Well-respected for his mentoring, coaching and love for teaching, CDR Yuen excels at bringing out the best in companies. With a passion for operational excellence and performance, he has often served as the catalyst for organizational and cultural “change” resulting in effective quality systems which emphasize the importance of “right first time” and proper root cause investigations and meaningful CAPA initiatives. CDR Yuen’s leadership and insights along with his endless energy and special charisma have influenced, shaped, and prepared many companies and their leaders for success during this challenging era of technological advancements and stricter compliance expectations.
Since leaving the FDA and building his well-respected consulting firm, he jas served as an acying transitional executive at several companies:
CDR Yuen possesses a BS in Biological Sciences from UCI, a Masters in Public Health (MPH) from UCLA, and an MBA from National University. CDR Yuen is a past President of the PDA – Southern California Chapter and former Board Member for the Institute of Validation Technology’s Journal of CGMP Compliance. Recently, CDR Yuen was awarded “Distinguished Alumni for the School of Biological Sciences – University of CA, at Irvine.
More than 20 years’ experience within the biopharmaceutical industry, specifically within GMP Quality Control testing and Quality Assurance. Qualifications include BSc Industrial Chemistry, MSc Industrial Pharmacy and IRCA certified PQMS Lead Auditor.
Extensive experience in auditing aseptic operations, contract testing laboratories, active raw materials, excipients, product contact materials, and primary packaging. This includes CDMOs/CMOs for filling, secondary packaging, serialization, cold-chain logistics and distribution services.
Soheila Dadgostari is a Quality Consultant with over 23 years of experience working with major pharmaceutical companies. Soheila supports Client’s with their Quality Assurance and Quality Compliance activities related to Quality Management Systems, Data Integrity/Data Governance, Computer System/Data Life Cycle Management, and addressing FDA Form 483 /Warning Letter Observations. Soheila uses her positive attitude and tireless energy to support and encourage her clients to work hard and succeed. Soheila is inspired daily by her husband and her daughter. In her free time, Soheila likes to hike, read and travel with her family.
Ruth has a distinguished career that includes more than 40 years of combined industry and FDA experience. Ruth’ distinguished career includes a Ph.D. in Cell Biology from MIT, Branch Chief at FDA, member of the ICH Expert Working Group on Quality of Biotechnology Products, Chair of the CBER/CDER group working on ICH virus and cell substrate documentation, and held senior roles at Baxter Healthcare/Baxalta and Shire. She brings significant knowledge of biologic products, BLA’s, and product reviews.
Tim has over 25 years experience in the pharmaceutical industry with expertise in API, solid-dose, and aseptic manufacturing facilities. Tim has worked extensively with laboratory and process automation. He began his career in the chemistry laboratory in analytical method development and technology transfer.
Chris Townsend has been consulting since 2012. Prior to consulting he worked for 14 years as a laboratory technician, trainer, validation lead, and system administrator in pharmaceutical and vaccine production. His experience as a chemist started when CFR Part 11 was in its infancy and many systems were paper based. Chris has been fortunate to watch the progression of the industry from paper to software, which gives him a unique understanding of data integrity. He has experience with many different systems in laboratory and production. Chris audits, remediates, and assists businesses to meet regulatory expectations.
Doug Schmidt has extensive knowledge in aseptic processing, quality control (microbiology and analytical), and quality management systems (QMS). Doug has a proven track record in developing practical systems for a diverse client set, coaching personnel to ensure sustainability in GMPs, remediating operational/QA/QC programs and conducting audits and assessments. Additionally, Doug is a qualified Lead Auditor.
Dr. Schlosser is an experienced QP and quality professional with more than than 20 years of experience in addition to his doctoral program. Dr Schlosser has experience in oral and sterile drug products ( including controlled substances), medical devices and inhalation products.
Ken Muhvich, Ph.D. is a microbiologist with extensive experience helping pharmaceutical and biopharmaceutical facilities establish effective viable microbial contamination control programs. He spent several years at the FDA and provides advice regarding the FDA’s expectations for firms manufacturing sterile products. He also aids clients that are investigating microbial contamination events.
Bob Mehta (M.S., M.B.A., ASQ Fellow) is a Senior Associate at Jeff Yuen & Associates with over 28 years of experience in the pharmaceutical, medical device, combination product, and biotech industries. Bob has a broad background including QA/QC/Operations/Supplier Audits, and FDA’s Warning Letter related remediation projects. He has co-authored a book titled “Practical Process Validation” and authored a book titled “Implementing ISO/IEC 17025:2017” and has authored several articles in Pharmaceutical Technology, MD&DI, and Quality Progress magazines.
Kevin McCulloch has over 35 years of experience with strong validation knowledge and great organizational and collaborative skills. Kevin’s experience includes many new installation and expansion projects from planning and design through qualification, startup, and into production. Kevin is adept with partnering across departments to execute projects while committed to professional standards and meeting deadlines.
Christina is a seasoned biochemical engineer (BSChE) with 25+ years of experience in MS&T, Quality Assurance, CMC, and Compliance in the pharma and biotech industries. Her experience includes cell therapy and combo devices. Christina provides expertise in GxP auditing, remediation, managing international CDMOs, CTOs and 3PLs, developing and optimizing production processes and QMSs, preparing technical regulatory documentation, and coaching leaders.
David has over 26 years of experience in the pharmaceutical industry covering sterile injectables, oral dosages, biologics, and combination products. His experiences include quality oversight of formulation, filling, labeling and packaging of aseptic and terminally sterilized drug products; managing 483, Warning Letter and Consent Decree responses and commitments; FDA pre-approval inspections (PAI); data integrity; environmental monitoring; and fermentation, purification and conjugation of biologic drug substances and drug products.
Mihaly joined Jeff Yuen & Associates in 2021 after serving with the United States Food and Drug Administration (FDA) for over 32 years as both a Chemist and a Consumer Safety Officer (CSO). Most of Mihaly’s service beng a CSO with Team Biologics. He retired from the FDA in December 2020. Mihaly has extensive experience conducting inspections of aseptic operations, vaccines, fractionated products, allergenics, biotechnology products, and certain biologic medical devices. he received numerous FDA awards during his FDA career and was a Certified Level III Drug Investigator for many years.
Joining JYA in 2018 as a Senior Associate, Louise Johnson provides GXP Manufacturing and R&D quality expertise based upon her 30 years in the industry. While in the industry, Louise led a number of quality organizations, managed the development and improvement of quality management systems, and resolved quality and regulatory challenges, including the interactions and challenges with global regulatory and health authorities.
Steven Hagen has worked in the biopharmaceutical sector for over 32 years. After attaining his PhD in Biochemistry, he worked for 14 years in positions of increasing responsibility in branded pharmaceutical development, with the last 11 years at Pfizer Global Research and Development.
Terri is an FDA investigator with 16 years’ experience in all areas of pharmaceutical inspections, domestic and foreign. She was trained and qualified to participate with an elite group called the pharmaceutical inspectorate. As a consultant she has nearly 20 years of consulting experience with Jeff Yuen & Associates in almost all pharmaceutical and biological GMP auditing and remediation areas.
Mark Dockter is a Senior-Level Consultant with over 21 years of regulatory and quality assurance success in the pharmaceutical, biopharmaceutical, 503B compounding and cosmetics manufacturing industries. Leveraging substantial experience ensuring compliance with regulatory agencies, Mark has been instrumental in quality program implementation and improvement as well as warning letter and consent decree remediation projects. His broad areas of expertise include compliance, quality assurance, process development and validation.
Yong Cho is an SME in CMC, regulatory, cGMP, quality system, compliance, audit (50+ in 2021-2), drug product, fill-finish, packaging & labeling, CMO oversght, and risk/gap assessment & remediation, and drug-device combination products development to submissions (pre-INDs, INDs, EOP2, BLAs, EMA MAA MDR Tech File w/ GSPR).
Andrew has more than 30 years of Quality Assurance experience in support of commercial and development activities. He specializes in design, remediation, and implementation of Quality Systems. He is an accomplished Trainer, with a focus on practical application of training topics to day-to-day operations. He also has extensive experience with Deviation Investigations, Change Control, Auditing and Inspection Readiness/Management. Andrew brings a practical, common sense perspective to his projects.
Baron Bowers has over 17 years of experience in the biopharmaceutical industry with a focus in aseptic processing and sterility assurance. He has a diverse background of both leadership and technical roles with a proven track record of success. Roles have included Vice President of Quality Operations, Site Director of Parenteral Manufacturing, Director of Technical Services, Director of Manufacturing Operations, and senior roles in both Project Management and Quality Control.
30 years with the FDA as a Field Investigator and Drug Specialist Investigator with experience conducting a wide range inspections including: drug and medical device manufacturers, cosmetics, food, clinical investigators, institutional review boards, methadone clinics, blood banks, plasmapheresis centers, and drug re-packers. Conducted hundreds of inspections of major domestic and international pharmaceutical manufacturers of a variety of dosage forms, including active pharmaceutical ingredients. Inspected hundreds of foreign drug manufacturers and clinical investigators in Europe, Russia, Israel, China, Korea, Japan, Taiwan, Singapore, Thailand, Canada, Mexico, and Australia.
Griet has over 25 years experience in the pharmaceutical industry with expertise in data integrity, quality systems, aseptic parenteral manufacturing, and quality control testing. Griet has been working with Jeff Yuen &Associates for the last 10 years. Griet’s background experience in product and analytical method development enables her to collaborate with a broad range of departments in a meaningful way. Currently she is working primarily on Data Integrity assessments, deviation investigations, and CAPA. Griet most enjoys working side-by-side with clients and their teams integrating improvements into the client’s current infrastructure and systems.
Peter Knauer has over thirty years of CMC/RA experience in the Biopharma Industry and is a subject matter expert in Combination Products. Peter has served as Vice President of CMC/RA and QC/Analytical for US and International based companies such as Xeris Pharmaceuticals, British Technology Group (BTG), Protherics, Jade Therapeutics and Symic Biomedical. Peter also served as COO of BioUtah. Peter started his career at Genentech, Inc. where he held numerous technical and leadership positions in pharmaceutical development and drug delivery. Peter has directly overseen multiple NDA/BLA/MAA and 510(k)/PMA market authorizations. Peter holds a Master’s Degree in Mechanical Engineering and a Bachelor’s Degree in Materials Science Engineering.
Marsha Steed has over 30 years of experience as a microbiologist working in the Pharmaceutical, Biotechnology and Medical Device fields. Marsha is the Founder and President of Steed MicroBio, LLC which is an independent microbiology consulting firm and a Senior Microbiology Associate/Sterility Assurance Expert at Jeff Yuen & Associates, Inc. consulting firm. Marsha is a globally recognized consultant specializing in sterility assurance and contamination control matters in pharmaceutical, biotech and medical device companies.
Marsha is a USP Microbiology Expert Committee member and the chair of the USP Microbial Control and Sterility Assurance Subcommittee. Marsha studied Biology at Western New England University in Springfield, MA.
Marsha is active in industry and currently serves on the Parenteral Drug Association (PDA) ATMP Advisory Board and has previously served on the PDA Education Advisory Board (EAB); Scientific Advisory Board (SAB) and has served on numerous PDA Task Forces and meeting planning committees and has been the chair of the PDA Annual Meeting and PDA Microbiology Meeting. Marsha is a former notified body ISO inspector.
A seasoned quality executive, Gary has lead quality and compliance organizations for more than 30 years. His experience includes laboratory operations, quality/compliance, and validation oversight for API/Drug Substance and sterile and non-sterile drug product programs. Gary’s previous companies include Teva, Mallinckrodt, Alcami (AAI/Cambridge Major Laboratories) and Exela Pharma Sciences. Most recently Gary has worked with our cell & gene therapy clients including clinical to commercial transitions, PAI readiness, remediation, supplier auditing and as acting head of quality. Gary has experience with domestic and international (Asia, Europe, South America) programs and has spent significant amounts of time abroad commissioning new facilities.
Mahshid has over 30 years of Quality and Manufacturing operations experience in small-molecule pharmaceuticals, biologics, medical devices and combination products. She has worked for large, reputable companies including GSK, Mallinckrodt, Baxter, Valeant, and Allergan. Prior to launching her consulting career, she functioned as Vice President of Quality for Valeant Inc., Baxter Medication Delivery, and Allergan Medical. Additionally, she has extensive experience in directing Quality Operation Teams in North America, Asia, South America, and Europe. Mahshid has developed and implemented Global Quality Management Systems throughout the product lifecycle (development, scale-up, commercialization, and post-market), and has provided critical leadership for organizations faced with global regulatory compliance issues and the need to build the right capabilities to support virtual and local operations. Mahshid’s specialties are in quality systems architecture, quality assurance, design controls, risk management, supplier quality, mock regulatory inspection, and due diligence audit. Mahshid has a BS in biological engineering and is a certified ISO Lead Assessor.
Rosalie has worked in the pharmaceutical industry for over 35 years with over 30 years experience in Regulatory Affairs managing various submission types sent to U.S. FDA. Her subject matter expertise covers sterile parenteral dosage forms. Rosalie has the ability to provide regulatory strategies and solutions throughout the life cycle of drug product development including R&D development, clinical studies, drug application, commercialization, and post marketing. She possesses a strong knowledge of U.S. regulatory requirements for drug products with sensitivity to the impact of regulatory decision-making on business operations. Rosalie has also been trained as a Lean Six Sigma Black Belt and can leverage her Lean Six Sigma knowledge to provide solutions which focus on efficiency and risk.
Paula served with FDA for 23+ years, 6 of those years as a Microbiologist and Biologics Investigator and 17 of those years as one of the original members of Team Biologics. She retired from FDA in December 2014 as a National Biologics Expert. Her experience on Team Biologics afforded expertise in regulatory affairs and GMP inspections of biopharmaceutical manufacturing, including aseptic processing and bioburden control processing of both bulk and final product for vaccines, biotechnologically derived therapeutics, plasma fractionated products, allergenics, and IVD products. She was also very active in training FDA personnel. Paula began working with JYA soon after her FDA retirement and has been active in assisting firms with corrective actions from FDA inspections, performing mock inspections, coaching during FDA inspections, and training employees.
Tom Savage served for FDA for 36 years as a chemist, a Regional Drug Lab Supervisor, the Deputy Director of the FDA regulatory science office, and as a Senior Policy Advisor in the CDER Office of Compliance. His experience included management of numerous high-profile scientific projects and response to various public health emergencies. During this time, he participated in multiple foreign and domestic inspections, and conducted training on various subjects related to FDA policy and regulatory science. Since leaving the Agency in 2010, he has consulted and performed training worldwide, specializing in laboratory GMPs and data integrity.
Prior to joining Jeff Yuen & Associates Steve was the Head of the Reference Standards Division at the United States Pharmacopeia where he oversaw all USP method development and validation laboratories globally as well as all reference standard operations and support laboratories.
Steve is a senior level executive with a diverse background. His broad expertise includes conducting GMP/ GCP audits to successfully leading large remediation teams to sitting in numerous interim Quality leadership roles. Steve has successfully participated in dozens of regulatory inspections over his 30+ year career. Immediately prior to joining Jeff Yuen & Associates, Steve was the Head of the Reference Standards Division at the United States Pharmacopeia where he oversaw all USP method development and validation laboratories globally as well as all reference standard operations and support laboratories. Steve began his pharmaceutical career in the laboratories of Baxter and subsequently worked for Alpharma USPD and Osiris Therapeutics in roles of progressing responsibility. Steve has a BS in Microbiology from East Tennessee State University and an MS in Biotechnology from Johns Hopkins University. Steve also studied in the Biomedical Engineering MS program at Harvard.
Scott is a recognized industry expert on visual inspection/particulates and is a member PDA’s Interest Group on Visual Inspection of Parenterals.
Scott received his BS in Microbiology from Western Michigan University and trained with McCrone Research Institute, Chicago IL. He has worked in the pharmaceutical industry for forty years, with positions in Upjohn, Pharmacia, Pharmacia & Upjohn and Pfizer. In his tenure, he directed the analytical labs supporting both quality control and R&D organizations. His teams identified and tracked the source of contamination and product instability, supported R&D product formulation development and evaluated new package presentations. He has developed and implemented microanalytical investigative processes in support of product improvement and formulation stability projects. Scott developed the legacy Upjohn system of Trace Analysis for particulate matter microanalyses and harmonized Pfizer’s global particulate matter control efforts and all pharmaceutical dosage forms, devices, packages and vendor processes were included in this responsibility.
For the last 16 years, he has been providing particulate matter control investigation and microanalytical training for personnel in the pharmaceutical, instrument and food industries. His passion is the application of materials science methods for the identification of particulate matter. Scott has published and presented his work in the field of visual inspection, microanalysis and spectroscopic analyses. He served on the USP Parenteral Products – Industrial 2005-2010 expert committee, and the USP Dosage Forms 2010-2020 EC. He chaired the various particulate matter chapter expert panels. Scott has designed and presented particle determination teaching modules for USP Pharmacopeial Education, and is an active member of PDA, ACS and various microscopical societies.
Chris Mondello joined the QACV Consulting team in March 2020. Prior to QACV, Chris’ experience in the pharmaceutical and biotech industries spans several decades. That experience includes:
Since joining QACV he has conducted upwards of 100 third-party and internal audits for our clients. Chris holds these certifications from the American Society for Quality:
• CQA – Certified Quality Auditor (certification #42361) since 04-Jun-2011
• CSQE – Certified Software Quality Engineer (certification #5206) since 02-Jun-2012
He also has an ITIL Foundation Certificate in IT Service Management from the PEOPLECERT Group (certification #GR750047997CM) dated 21-Feb-2013.
Chris earned an M.S. in organic chemistry from Northeastern University (Boston), and a B.S. in chemistry from Houghton College (now Houghton University, Houghton, NY)
Chris is a member of the board of directors for Project Response (Brevard County, Florida), a non-profit organization that has provided a safe space for HIV/AIDS services for over 30 years.
John has recently joined the QACV Consulting team with over 30 years of bio-pharmaceutical experience in several different roles including engineering, technical operations, manufacturing, quality assurance and information technology. Mr. Patterson possesses current skills in the development and deployment of quality management systems, risk management frameworks, quality auditing & governance and computerized systems validation including infrastructure qualification (including Cloud IAAS), application (MES) validation and GxP data integrity assurance.
John also possesses significant experience preparing, managing and responding to IT & automation topics during GMP & GCP regulatory inspections. Mr. Patterson has also been involved with bringing cybersecurity to GxP systems and has been responsible for establishing an information security and data protection capability in his most recent role. John keeps his skills current through regular speaking engagements at industry conferences, active involvement with multiple ISPE and industry SIGs and authoring/co-authoring of technical articles in leading industry publications including topics such as MES Validation (Institute of Validation Technology – IVT), Risk Management (ISPE Baseline Guide, Oral Solid Dosage Forms) and Bringing Cybersecurity to GxP Systems (Pharmaceutical Engineering Magazine). John has a M.S. in Engineering from Purdue University and a B.S. in Agricultural Engineering from the University of Wisconsin-Madison.
Chris has over 25 years experience in regulated industry and has provided compliance, quality assurance and computer validation consulting services since 2001. Specializing in computer systems compliance, including validation, as well as quality assurance activities such as auditing, training, and six sigma quality improvement processes. Prior to consulting, Chris worked at Hoffmann-La Roche, Aventis Pasteur, Johnson & Johnson, and Lancaster Laboratories in several compliance and validation functions, including Group Leader/Manager of Computer Validation, Product Complaints and Supplier Audits, leading and supporting both global and site compliance and validation efforts. Chris remains current in industry trends and requirements and frequently speaks or provides workshops at leading industry conferences and programs. Chris was a contributing member of the ISPE GAMP Laboratory Systems Special Interest Group, which published the Good Practice Guide “Validation of Laboratory Computerized Systems” and was a chapter chair and editorial board member for the DIA’s recent publication “Computerized Systems in Clinical Research: Current Data Quality and Data Integrity Concepts.” Chris has a Masters Degree in Quality Assurance and Regulatory Affairs and a BS in Physics and Computer Engineering, along with a Six Sigma Black Belt Certification
Moj has over 2.5 decades of experience in the life sciences industry with primary expertise in medical devices and combination products quality and regulatory affairs, product design and development, research, technical writing, and project management.
Moj is a Co-Founder and Sr. partner at Sage BioPartners and Sr. Associate at Jeff Yuen and Associates specializing in quality, regulatory, product development, project management consultation and services in life science regulated industry with specialty in medical device and combination products. Moj expertise lies in quality system and subsystems gap assessment, creation and implementation of quality management system according to 13485, ISO 9001, 21 CFR 111, 21 CFR 210/211, 21 CFR 1271, 21 CFR Part 4, 21 CFR Part 11, EU MDR, FDA regulations, and other related standards. She has extensive experience in risk management, audit (supplier, internal, for cause, FDA mock, ISO, MDSAP readiness, EU MDR), CAPA, complaint, design and development, DHF among others. Moj has experiencein remediation and has worked with many clients on remediation projects including FDA 483 and warning letters.
Moj regulatory expertise lies in FDA regulatory submissions including 510k, TMF, and technical files, and assist clients in the review process. She has completed projects including Technical documentation for the EU CE marking, clinical evaluation plans and reports for EU MDR CE marking or updated the documentation for compliance to EU MDR submissions.
She is a member of Regulatory Affairs Professional Society (RAPS) Utah Local Network Chapter. Moj also serves as an advisory board member for medical device startup companies, where she provides regulatory, QC, product development, and commercialization strategies to clients.
Moj has a bachelor’s degree in biology from Oregon State University, a PhD in medical physiology from the University of Utah School of Medicine, and a graduate certification in regulatory affairs from Utah Valley University.
Area of expertise: ISO 9001, 13485, ISO 14971, 21 CFR 111, 21 CFR 210/211, 21 CFR 1271, 21 CFR Part 4, 21 CFR Part 11, EU MDR 2017/745, FDA CFRs, medical device software life cycle (IEC 62304) and cybersecurity, QMS, QSR, GMP, GTP, and ISMS.
CMC analytics, Quality Control laboratory, and Control Strategy for Biologics and Cell Gene Therapies
Dr. Lee is a highly experienced biotech leader with 15+ years of experience with technical domain knowledge and a strategic business mindset in drug development. She has a diverse scientific background covering oncology, immunology, genome-editing, and CMC knowledge with an end-to-end business mindset for drug development from early to late stages.
Over her career, Dr. Lee developed in-depth analytical and CMC expertise supporting IND to BLA of diverse modalities, including monoclonal antibodies, antibody-drug conjugates, bispecific molecules, and cell and gene therapies, including TCR-T and CAR-T therapies with different delivery vectors. Her experience includes product development planning, analytical method development, qualification/validation, technical transfer, setting up laboratories, designing characterization and control strategies, authoring/reviewing GMP documents, and regulatory
filing.
Dr. Lee is also a founder of Elevalue Consulting LLC and serves as a PDA Biopharmaceutical Advisory Board member. She previously served in various positions at Kyverna Therapeutics and Genentech. Dr. Lee was a senior director of analytical development at Kyverna Therapeutics, supporting autologous and allogeneic cell therapies. At Genentech, she supported >10 biologics and cell therapy products from pre-clinical, clinical, and commercialization for potency assay development and other QC release and characterization assays. She led multiple cross-functional analytical and CMC teams.
Dr. Lee did her postdoctoral fellowship under Professor Jennifer Doudna at UC Berkeley for regulatory RNA molecules. She holds a Ph.D. in Chemistry from Stanford University and EMBA from Quantic School of Business.
Born in Venezuela in 1957, migrated to New York City in 1974 where I completed my undergraduate studies and, in 1979, earned a BS degree in Mechanical Engineering from the “New York Institute of Technology”.
I worked for Ford Motor Company in Mexico and in Venezuela until 1982, when I moved to Miami, Florida and entered the medical device industry. Since then I have accumulated over thirty years of combined multifunctional technical experience and expertise in developing and implementing quality systems in the medical device industry.
In 1983, I began working as an engineer with Cordis Corporation – a Johnson & Johnson Company and a global leader in developing and marketing devices for circulatory disease management including stents, balloons, and catheters used in treating cardiovascular disease. For the next 14 years, I rose through the ranks obtaining various management positions in Quality Assurance, Manufacturing, and R&D Engineering, supporting Operations and Product Development activities.
In 1998, I left to join World Medical Company, then a small start-up, but a significant player in the development and manufacturing of stent grafts for the treatment of abdominal and thoracic aneurysms. In my role as Director of Quality Assurance I was responsible for overseeing the development, implementation and management of the quality system for the organization.
In 1999, the company was acquired by Medtronic-AVE, a world leader in medical technology providing lifelong solutions for people with chronic disease. My role and responsibilities were then expanded to lead the integration of the quality system and to provide management support to regulatory and clinical organizations.
In 2004, I joined HeartWare Inc., another start-up company developing ventricular assist devices which, in lieu of a heart transplant, either assist or assume the natural heart’s pumping functions. In my role as the Head of Quality Assurance & Compliance I was responsible for overseeing the development, implementation, and management of the quality system for the organization.
In 2015, I started a consulting company providing strategic guidance and operational support in the areas of quality and corporate compliance to biotech and pharmaceutical companies operating in GMP compliance with US FDA QSR and ISO Standards.
In 2017, I joined Braeburn Inc., a USA based biopharmaceutical company developing medicine drug products to treat patients suffering with opioid use disorder as the Head of Quality responsible for the implementation of the company’s Quality Management System.
Dr. Govind S. Pandey is director of a Gamp Technologies Private limited. He is a Senior Associate of Jeff Yuen & Associates Inc. USA, who has over three decades of experience in the pharmaceutical industry. He is a professional experienced in sterile operations, solid oral dosage forms and API. He supports in setting up many finished dosage form and API manufacturing sites. He possesses a deep understanding of business strategy relating to Operations, Quality Assurance, Quality control, CMC submissions, Facility design, Tech transfer & Regulatory guidelines. In addition he is black belt certified person on “Six Sigma- Process optimization and Problem solving”. He has provided expert scientific support for the timely resolution of issues raised by USFDA & other Regulatory agencies.
Elvia has over 40 years of experience in the pharmaceutical industry in the specific area of Regulatory Affairs with approximately 20 years of consulting experience. Elvia has been a consultant with Jeff Yuen & Associates since 2006. Her expertise in Regulatory Affairs includes life cycle management of submissions from pre-clinical to post-marketing stages of API and drug product development. Over her career, Elvia has developed a rapport with the U.S. FDA as an effective liaison for her clients both foreign and domestic. As a result, Elvia has the ability to work cross-culturally, especially Latin America. She has supported projects to facilitate the Regulatory Affairs strategies for sterile drug products, oral dosage forms, and APIs.
Dan Larimore has over 25 years of experience in the pharmaceutical, biotechnology, and medical device industries. His career has focused on quality management, compliance, audit, and business development/acquisition evaluations. Prior to joining Jeff Yuen & Associates, Dan has held positions at manufacturing facilities and in various corporate quality roles. His experience includes Quality Management at Baxter Healthcare, a corporate role at Allergan, and Quality site head and Vice President positions at Alcon Laboratories. Dan has extensive experience performing managing complex compliance projects such as remediation, contract manufacturing, business development/acquisition evaluations, compliance remediation, and preparing companies for and hosting regulatory inspections. His experience includes direct management for FDA (CDER, CBER, and CDRH), EMEA, PMDA, ANVISA, Health Canada, KFDA, and Notified Body audits. Dan has a BS in Microbiology from Indiana University.
Trent Davalos is an experienced executive with 22+ years specializing in helping global Medical Device, Pharmaceutical, and Combination companies design, develop, and/or continuously evolve innovative products, manufacturing facilities, business systems, operational excellence, and product safety programs resulting in multiple successful regulatory approvals and continuing scale.
Throughout his career, Trent has held several executive positions where he has been responsible for supporting corporate formation and/or their evolution while defining regulatory, quality, and business strategy in the product technology areas of mechanical engineering, chemical engineering, animal derived materials, biologics, hardware electronics engineering, combination products, enterprise data networks, smart manufacturing, product software and applications, and auditing them for compliance.
Trent has served as Head of Regulatory and Quality for companies in the diabetes industry and multiple Foxconn entities, including Foxconn Industrial Internet as part of United States Presidential Wisconsin Project, and as the Global Director of Quality for Dexcom as one of the key contributors to accelerate the growth of Dexcom after the initial public offering from $47M to $12B Market Cap.
Trent received his Bachelor of Science degree in microbiology and minor in chemistry from Oregon State University.
Susan Neadle (MS, BS, FAAO) is a recognized international Combination Products and Medical Device expert with over 30 years of industry experience. Networked, published, highly active in numerous industry groups with links to teaching institutions, Susan brings deep knowledge and genuine passion for sharing that knowledge with others. Susan’s leadership, innovation, and best practices have been recognized with multiple awards, including the 2022 ISPE Joseph X. Philips Professional Achievement Award for significant contributions as an integrator of industry and regulators; the Johnson Medal, Johnson & Johnson’s highest honor for excellence in Research & Development; and as a Finalist in TOPRA’s 2021 Awards for Regulatory Affairs Excellence.
Among her industry contributions, she serves as Chair of the ISPE Combination Products CoP, as lead author for Combination Products standards efforts in ASTM International and AAMI, is active in Combination Products Coalition, and serves on the AFDO/RAPS Combination Product Steering Committee. She serves as faculty at University of Maryland Baltimore County Campus College of Natural and Mathematical Sciences and at AAMI for Combination Products and Medical Device Quality System Curricula. She speaks frequently at public venues on wide-ranging combination products topics and has authored an FDA peer-reviewed book, “The Combination Products Handbook: A Practical Guide”.
Prior to consulting, Susan retired from Johnson & Johnson after a distinguished 26+ year career. Throughout her tenure, including integral leadership roles in R&D, Quality Engineering & Risk Management, and Design-to-Value, and as Chair of J&J’s Design Council, spanning Biopharma, Medical Device and Consumer Health sectors, she consistently advanced world-class practices in customer-centric product & process design, development, and commercialization. Susan also served as Amgen’s Head of Combination Products, Devices, Digital Health & IVD RA.
David oined Jeff Yuen & Associates in 2016 and brings over 25 years of experience in contract laboratory and drug manufacturing (CRO/CDMO) sector of the pharmaceutical / biopharmaceutical industry. David began his career as a bench chemist developing and validating analytical methods, before transitioning to Quality Control and senior QC leadership roles. Practicing holistic, integrated change across all areas of business and laboratory operations, leading teams to technical excellence and strong regulatory compliance and fiscal responsibility. He specialized in re-defining underperforming CRO/CDMO’s to profitability, sustainability and scalability for growth and future development. His final indusgry position was head of the analytical services division of a US-based CDMO.
As a Senior Associate with Jeff Yuen & Associates, David provides Quality Assurance and Quality Control laboratories consulting services to the pharmaceutical & biopharmaceutical industries throughout US, EU and Asia, including:
· Alignment and optimization of business, technical, operational & Quality functions to improve regulatory compliance, profitability, sustainability and scalability for growth and future development.
· QA/QC support of transformation from non-commercial to commercial operations, including PPQ readiness, QC laboratory controls, method validations, technology transfers and CDMO management.
· QA/QC remediation of regulatory citations and system improvements.
· Auditing services (GxP and ISO17025) of Quality Systems and laboratory controls from early phase through commercialization.
Tammy Lucik is a dynamic Quality professional with 30 + years of experience in Quality Management. A senior level executive responsible for quality staff of 200+ for clinical and commercial drug substance and drug product manufacturing. Extensive experience in leading regulatory inspections, relations and communications. A proven leader in implementing First in Class Quality Systems. Tammy has worked over a decade with Jeff Yuen & Associates as a senior associate, consulting in Biotech, Vaccines, Cell Therapy, Sterile Manufacturing, Solid Dosage and API Manufacturing. Tammy excels in the development, coaching and mentoring of quality teams and eagerly takes on acting Site-Head of Quality roles to make a positive impact. Tammy is also a top associate for leading key remediation projects while successfully collaborating with clients on compliance goals and initiatives.
Tamara is a results-oriented Quality Assurance leader with over 30 years of industry experience, having held both plant and corporate level positions with multi-national pharmaceutical and medical device firms. Tamara is recognized for her ability to assess, develop, implement, improve and/or remediate Quality Systems in a pragmatic manner, tailored to “fit” each client. Tamara loves consultanting, as it provides the opportunity to not only leverage her experience to develop strategic solutions which make an impact on clients, but also the opportunity to share what she has learned throughout her career, by mentoring and coaching clients.
Suraj Baloda, Ph.D. is the Founder & President of SARMICON, LLC., located in Acton, MA, USA. Dr. Baloda is a pharmaceutical quality professional and microbiology expert with more than 35 years of global experience in the pharmaceutical, biotechnology, and related industries, and academia. He is experienced in Aseptic Processing of Sterile Liquid and Lyophilized formulations (Injectables), Solid Dosage Drug Products, Contamination Control, Quality Assessment, Execution of Remediation Actions, and Improvement Plans, CAPAs, Deviations, Root Cause Analysis and Investigations, Sterilization Science and Technology, R&D (Product Development), Conducting Training, and more. He has global consultancy and training experience and over the years worked with multiple clients in USA, Canada, Italy, Spain, Japan, China, South Korea, South Africa, Brazil, India, and Bangladesh, etc.
Paul Leander has 25 years of experience working in Quality and Compliance in the biotech and pharmaceutical industry. With an in-depth knowledge of global health regulations and extensive expertise on GMP, GTP and GDP audits, Paul has led over 500 audits in the Americas, Europe and Asia. These audits have included apheresis and cell collection centers, infusion sites, drug product and drug substance CDMOs, testing laboratories, raw material suppliers, medical device manufacturers, packaging sites, and warehouse/distribution centers. Prior to becoming a JYA Senior Associate in 2020, Paul worked for Biogen, Takeda, Merck, Sanofi and Bluebird Bio. Paul graduated from the University of Massachusetts with a BS in Biology.
Mujtaba is a Quality Executive with 30+ years of US experience in Operational, Compliance, and Quality best practices. His professional strengths include:
• Small and Large Molecule, Cell Therapy, mAB, Sterile Products
• Phase Appropriate Quality Systems including Data Integrity and Data Governance
• Multi-Site Oversight for Quality Operations oversight including operations and batch release for Commercial / Clinical
• Contract Manufacturing Organization oversight for Quality / Manufacturing processes
• FDA Inspection Preparation Readiness, CAPA & Audit Remediation
• Validation Program Development and Oversight
• Technical Transfer & Facility Operations, Engineering / Calibration Oversight
• Supplier Quality Oversight processes including audits, supplier qualification and others
• Data Integrity Governance program and Audits
• Training Expertise on GMP, Quality Systems and Data Integrity
Michele Pruett studied Medicinal Chemistry at the Pharmacy School at the University of Buffalo, SUNY. Over the span of her 30 plus years in pharmaceutics, she has lead quality control laboratories, managed quality assurance departments, and helped remediate problem areas. Michele has a unique perspective on the modern archetype of the virtual pharmaceutical R&D company, which has the scientific, business and compliance core in-house while outsourcing manufacturing, packaging and clinical activities to key strategic partners. In her quality and compliance background she has been in the role of Analytical Lead/SME, Head of Quality, and taken on multiple Interim Vice President of Quality roles while helping companies identify a good fit for the FTE position. She has enjoyed the excitement of building CMC sections, receiving approval for new drugs, and felt the heavy weight of responsibility serving populations with unique needs such as the immunosuppressed, pediatrics, and rare disease.
Quality professional with 2 decades of experience including oversight of parenteral manufacturing and testing (focused experience in pharmaceutical microbiology), quality systems, CMC regulatory submissions and oversight of CDMOs and other outsourced GMP activities. Mary is a demonstrated QA leader for multiple fast-tracked oncology products in late-stage development/PPQ, transitioning to commercial stage and a saavy working with CDMOs under regulatory scrutiny (warning letters, CRLs). Mary is also an inspection team coordinator for multiple US/EU regulatory inspections and provides inspection management training. She is a certified GMP Quality Auditor with extensive auditing experience (US, EU, China; API, biologics, small molecules, test labs, fill/finish, packaging and labeling).
Jonathan Briggs has over 35 years of industry experience, including 24 years in Quality. His career has focused on quality, compliance and providing solutions to complex drug development challenges including drug product manufacturing and execution of clinical and non-clinical studies. Prior to joining Jeff Yuen & Associates, Jonathan served more than ten years in Quality Management including Head of Quality at Genocea Biosciences, Karyopharm Therapeutics, and Genmab and also as Site Head of Quality at both Alexion and Lonza. Jonathan has extensive experience performing gap assessments, QMS remediation, and preparing companies for and hosting regulatory inspections. Jonathan has a BA in both Chemistry and Biology from the University of California.
Erwin Andrews has 16 years of experience in the pharmaceutical industry. Those 16 years have consisted of aseptic manufacturing leadership and quality assurance leadership roles. In these roles, Erwin has focused on instilling a quality mindset in his organizations. Prior to joining Jeff Yuen and Associates, Erwin worked with leading commercial and contract pharmaceutical companies (Merck, Novo Nordisk, Catalent, Emergent, and Pharmaceutics International, Inc.). Erwin developed a strategic vision for his teams and worked with them to accomplish the vision. Erwin has a BS degree from North Carolina Agricultural and Technical State University.
A qualified and experienced Microbiologist and Analytical Chemist who has completed EU QP training, with over 30 years’ experience in QC, R&D, QA and Regulatory Affairs functions. Has held both permanent and interim senior leadership roles in large pharma, biopharma, early phase CDMO clinical sites, and CROs. Highly experienced international auditor able to work to EU GMP, GDP, US FDA and ISO 9001, 17025 and 13485 requirements. Has led FDA PIA readiness, inspection remediation and technical transfer initiatives as well as providing support for regulatory compliance review programs, person in plant assignments, lean lab and PQS improvement projects. Has also supported new build and re-location projects and developed and delivered training programs in GMP, GDP, data integrity, analytical development, equipment and facility validation and process scale up.