Kim Huynh-Ba has almost 25 years of experience in analytical development, project management, strategic drug development and stability sciences. She currently is the Executive Director of Pharmalytik, where she provides consulting and training services to pharmaceutical companies, including companies operating under FDA’s Consent Decree on harmonization and optimization of analytical best practices since 2003. Her clients are from various sizes of pharmaceutical companies in US and abroad. Prior to Pharmalytik, she was the Director of Pharmacopeial Education Department of U.S. Pharmacopeia (USP), where she was responsible for their education programs worldwide. Kim has held several technical and quality positions at Astra Zeneca (formerly ICI Americas), DuPont Merck, DuPont Pharmaceuticals, Bristol Myers Squibb and Wyeth Vaccines. Kim is also a short course instructor on cGMP compliance and quality topics for several global organizations such as American Chemical Society (ACS), American Association of Pharmaceutical Scientists (AAPS), Pittsburgh Conference, and many other international training groups. She is an Adjunct Professor at Temple University-School of Pharmacy, Widener University and Illinois Institute of Technology (IIT) teaching pharmaceutical analysis and analytical chemistry graduate courses.
Kim is a member of the Executive Committee of Governing Board of Eastern Analytical Symposium (EAS) and is their 2013 President. She is the Chair of USP Good Documentation Practices Expert Panel (2010-15) and a member of USP Impurities of Drug Products Expert Panel (2012-15). She was also a member of USP General Chapter Expert Committee (2010-15), member of USP Reference Standard Project Team and USP Prescription/Non-Prescription Stakeholder Forum of previous cycle. She was a member of the Consumer Healthcare Product Association’s (CHPA) Stability and Impurities Breakout Groups. Kim currently is a member of AAPS Publication Committee, Chair of the Stability Focus Group and serves on the Steering Committees of CMC and Pharmaceutical Trace Impurities Focus Groups. Kim is a recipient of the 2008 Service Award of Analysis and Pharmaceutical Quality Section and 2008 Recognition Award of Regulatory Section of AAPS. She also received the 2001 DuPont Pharmaceutical Company Asian American Leadership Award.
Kim has authored numerous technical publications and book chapters and has spoken extensively, both domestic and internationally, of the compliance and quality areas. She is the editor of the “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices” (2008) and “Pharmaceutical Stability Testing to Support Global Markets.”
Heidi Liu is currently acting as Quality Assurance Leader & Global Life Science Consultant in Wilder & Schiemann Ltd.
Kathleen Warner, Ph.D., VP of Consulting Services for RCM Technologies, Life Sciences, is an executive consultant with 25+ years of experience in information technology (IT) and the life sciences.
Michael Zhang, Regulatory Franchise Leader, Widler & Schiemann Ltd, Shanghai, China
Katrin Rupalla, SVP, Global Head Regulatory, Medical Documentation and RD Quality, H.Lundbeck A/S, Copenhagen, Denmark
Monica Guzman is an Executive Coach and Corporate Trainer with over 12 years in the learning and development field.
John Giantsidis is the President of CyberActa and brings a deep understanding of the rapid development and constantly changing landscape of our industry.
Kevin takes a practical approach which allows scientists to assess risk with limited data sets. He is effective in facilitating team discussions to document current state product and process understanding.
Dalfoni Banerjee is an award-winning, solution-focused entrepreneur. Beginning her career over 25 years ago in academic, pharmaceutical, and biotechnology research laboratories, she went on to lead inspection-readiness efforts, drive clinical research and clinical operations, manage relationships between pharma and key opinion leaders, develop marketing strategies/tactics, and launch new drug products – across 12+ therapeutic categories
Expert in process improvement, metrics, and root cause analysis in clinical trials
Brooke L. Casselberry
Brooke Casselberry is the founder of Cyan Life Sciences, providing consulting services across the regulatory product lifecycle. Brooke’s experienced in developing regulatory domains, expanding business, and supporting clients in knowledge exchange, technology procurement and support, project management, and methodology development.
Natalee received her Nursing Degree from Union University and has practiced in the areas of Intensive Care and Surgery. She has a background in Sales and Sales Management in Home Infusion, Capital Equipment, Surgical devices and Biologicals.
Jerry Chapman is a GMP consultant with nearly 40 years of experience in the pharmaceutical industry.
Greg Martin is President of Complectors Consulting (www.complectors.com) which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. Mr. Martin has over 25 years experience in the pharmaceutical industry and was Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for a number of years.
Lisa Olson has over 30 years of experience in FDA-regulated industry, with a major pharmaceutical company, three CROs, and in consulting roles. With a background in system development and support of clinical research systems, she developed her career into regulatory compliance of computer systems and a specialization in 21 CFR Part 11.
Luisa Monica’s experience includes oversight of electronic TMF (eTMF) implementation, quality control, coordination of migration projects, facilitated training programs, enhancement and development of TMF processes, and extensive inspection readiness preparation for FDA and MHRA inspections.
Jackie Morrill’s experience includes oversight of electronic TMF (eTMF) implementation, coordination of a large migration and integration projects, development of robust metrics and training programs, enhancement and development of TMF processes, and extensive inspection readiness preparation for FDA, MHRA, and PDMA inspections.
With 10 years of experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification.
Terry is an implementation consultant for rfxcel whose mission is to provide a reliable track and trace solution for Manufactures, Re-packagers, Wholesale Distributors, and Dispensers.
Penelope Przekop, MSQA, RQAP-GCP
Penelope Przekop, RQAP-GCP, is a Quality Management Systems, Assurance & Compliance Consultant with 25 plus years of experience in Pharmaceutical GxP Global Quality Systems with key focus in clinical development, data management and pharmacovigilance.
20 years of Learning and Development and Organizational Development Experience
20+ years of Learning and Development in Pharma and Biotech
Jack Tarkoff is Chief Strategy Officer and co-founder of rfxcel with the vision of building a product that would meet the track and trace needs of pharmaceutical industry.
Rich Yeaton has over twenty five years’ experience working in FDA regulated industries.
Over 15 years of experience in quality and validation functions in the pharmaceutical industry.
Dr. Ben Locwin has been an executive for Top 10 pharma companies, as well as advising startups and biotech organizations to boost their market launches and profitability. He has consult for the major regulatory bodies across the world on topics such as inspection practices, drug safety, and data analysis.
Peter T. Vishton, P.E.
Peter is an Independent Pharmaceutical Water Systems Consultant working with several companies. He has 25 years of experience in the Pharmaceutical area which includes 10 years with Pharmaceutical Water Systems.
Michael Esposito has over 30 years’ experience in the pharmaceutical industry and 14 years’ experience in GMP training and document management.
Dr. Good has spent his years in industry in Manufacturing, Project Management, and for the last 12 years, Quality. Throughout his career, he has helped remediate Consent Decrees, Warning Letters and many FDA Observations. He has worked with Fortune 500 Pharmaceutical and Biotechnology companies and solved complex, multi-operational compliance issues. Dr. Good has spoken professionally at ISPE and PDA regional and national meetings on the subject of Compliance risk and solutions.
Erich Bozenhardt has 11 years of experience in the biotechnology and aseptic processing business and has led several biological manufacturing projects, including cell therapies, mammalian cell culture, and novel delivery systems.
David Kane, with over 20 years in the field of technology, is the CEO of Ethical Intruder, a Pittsburgh based Cyber Security firm and focuses on Cyber Security related to software products.
Mary Jo Egbert
Expert in Engineering Equipment and Scientific Instrument Qualification.
Training specialist in training system management, LMS administration, instructional design, and training delivery.
Experience managing and executing all aspects of a cleaning validation program and defending it routinely before regulatory agencies.
Expertise includes trial management, protocol writing, clinical development plans, vendor management, vendor assessment and issue resolution, gap analysis, program management, regulatory submissions and SOP writing.
Understands how FDA thinks and operates, and where it is headed.
Specialties contract negotiation, alliance management, drug product development, risk management, commercialization and life cycle management.
Experience in global operations, technical management, strategic planning, implementation of environmental health and safety programs, regulatory compliance and engineering support in a Fortune 200 setting.
Managing Partner at Widler & Schiemann Ltd, focusing on all aspects of clinical development from Protocol Quality by Design to Study set-up, Project Management and Risk-based oversight of Clinical Trials.
Specializes in the risk-based monitoring of pediatric and adult pharmaceutical, biologic and medical device clinical trials, in compliance and data management auditing and in training and education.
Developed, transferred and validated purification processes for multiple new molecular entities through all stages of drug development, including licensure.
Passionate trainer with highly efficient problem solving skills which she uses to design, develop, and deliver training programs.
Expertise includes country and site selection principles, acceleration of site initiation, technology implementation and supplemental recruitment support.
Recognized as an executive level change agent and business process analyst for efficient submission assembly, dossier management and eCTD/eCTD life-cycle production.
Represents a variety of participants in the regenerative medicine industry, both public and private.
15+ years in clinical development, providing consulting services to a wide range of pharmaceutical, medical device, biotech, and CRO clients in the US and Europe.
Experience spans large and small molecule development and has played pivotal roles in designing novel ways to screen compounds for safety, resulting in several marketed products.
Represents clients in highly regulated industries, such as regenerative medicine and other FDA-regulated issues.
30+ years of GMP, GLP, and GCP quality assurance and compliance experience with Active Pharmaceutical Ingredients (APIs), clinical research materials, and finished product.
25 years’ in analytical development, project management, strategic drug development and stability sciences.
Specialties include emerging company clinical research management and training, curriculum development, change management, CGP, and project management oversight.
Specialties in regulatory submissions (US and international) and clinical trial management/studies.
Founder of Rebar Interactive, a digital marketing company serving the clinical research industry, and former research coordinator.
Diversified project management and execution experience both in domestic and international settings.
Recognized expert in computer system validation and 21 CFR Part 11 compliance.
Currently writing a Project Management novel, set in King Arthur’s time, to teach PM techniques in an entertaining way.
Specializes in the development and maintenance of quality systems, batch review and release, and conducting of both internal and external compliance audits.
17 years in drug research and development, specifically focusing on cardio-renal and oncology indications from both the CRO and Sponsor side of clinical development.
Mark Allen Durivage
Lead on-site quality inspections at facilities throughout the North America, Europe, and Asia for a $4.5B manufacturer of orthopedic products and instruments.
Helps pharma professionals learn how to become trusted, valued partners to healthcare providers.
Christina Meyer Dell Cioppia
Has assisted biopharma, vaccine, pharma, and aseptic processing firms worldwide in commissioning, qualification, validation, design reviews, cGMP audits, and worldwide regulatory compliance.
Focused on regulatory strategy for novel products and applications, products intended to meet unmet healthcare needs, and projects involving vulnerable populations.
Specializes in providing regulatory and organizational strategy support, process improvement, inspection readiness support, and integration and harmonization of SOPs for medical device and pharma companies.
Has successfully led companies in the Generic Drug Industry and Pharmaceutical CMO Business.
Diverse therapeutic experience background includes cardiology, neuromodulation, asthma/allergy, Duchenne muscular dystrophy, hereditary hemophilia and diabetes.
Quality Management System expertise covers all aspects of developing, training, implementing and maintaining compliance with ISO 13485 and ISO 14971.
Experience includes Clinical Operations training, risk management program development, study and program management, study monitoring, and drug safety.
Experience with large scale initiatives such as assessments and implementation of organizational data integrity and compliance frameworks and responses to FDA warning letters and consent decrees.
Extensive knowledge and experience in the application of FDA law, regulations, and policy, particularly as it relates to compliance and enforcement programs and strategy.
Helped over 300 companies and organizations from Fortune 100 to entrepreneurial companies develop leadership, corporate turnarounds, team building and managing change.
Ph.D. biochemist with over 25 years’ industrial experience in methods development, quality assurance/quality control and CGMP compliance.
Extensive experience in fields such as biodefense, pharmaceuticals, medical devices, pre-clinical, non-clinical and clinical studies.
Specialties include regulatory affairs, strategic development for drugs, devices and biologic products, and GMP/GLP/GCP compliance.
Experienced in manufacturing technologies producing aseptic and terminally-sterilized parenteral API and finished drug products, solid and liquid oral products, inhalation drugs, and radiopharmaceuticals.
Herman Bozenhardt has 41 years of experience in pharmaceutical, biotechnology, and medical device manufacturing, engineering, and compliance.
Focused on solving New Drug Development issues for small and medium sized companies.
Michael Pierro, a highly experienced facilitator and subject matter expert, provides clinical operations and GCP/SOP training to the biotechnology, CRO and pharmaceutical industry.
Focuses on operations management for small manufacturing companies, including quality assurance, quality management, production planning, inventory management, and health/safety.
Experience in Discovery, CMC, Clinical Operations, Medical Writing, Pharmacology/Toxicology, Pharmacovigilance, Alliance Management, and Quality Assurance.
EU and US regulatory and quality management systems expert in design controls, risk management, combination products, and moible health.
Currently responsible for clinical research product development services at Cardinal Health Regulatory Sciences.
Recently completed an IDMP Pilot project for a fortunte 50 pharma manufacturer and previously worked on UDI projects for medical device clients.
Expert in device design, documentation, submissions, supporting quality systems and internal/pre-FDA auditing to device, pharma tissue, and cosmetic industries.
Expertise in clinical development, medical affairs, business operations, project management, process optimization, metrics, and data-driven strategic planning.
Judy Carmody, Ph.D.
Expertise driving vision in operations, QA, control, systems, and validation/analytical development within global organizations.
Hands-on Project Manager for large projects including computer systems validation , lab system validation and instrument qualifications.
Helps companies use 21st century technology to communicate about prescription products while remaining compliant with FDA regulations from the ’60s.
Danielle is a subject matter expert specializing in quality assurance and quality systems. She assists companies facing warning letters and consent decrees as well as those wishing to improve GxP practices and establish more robust quality systems.
Works regularly for the FDA, Health Canada, the US and European Patent Offices, and other regulatory and governmental agencies worldwide.
Areas of expertise include systems training, training effectiveness, post-training user support, process improvement, and sustainable packaging.
Expert in clinical operations, data management, and clinical software with over 25 years of pharmaceutical experience.
J. Jeff Schwegman
Founder and CEO of AB BioTechnologies. He also lectures on formulation, stabilization and process development of lyophilized products.
Helps companies find and implement computerized systems that increase efficiency, sustain compliance, and ease business pain.
Quality & Regulatory Compliance Senior Manager for the Medtronic Heart Valves Center of Excellence/Cardiac & Vascular Group.
Sandra “SAM” Sather
Industry-leading consultant whose mission is to promote clinical quality systems for Sponsors/CROs and Investigators/Research Institutions.
20+ years of technical and operational experience within pharma, biotech and medical device manufacturing environments.