2024
Distinguished speakers & panelists
Teresa Forlini, B.Eng. Chemical Engineering
Regional Compliance & Enforcement Manager, GMP Inspections
Regulatory Operations and Enforcement Branch
Health Canada
Teresa Forlini oversees the Québec regional team of GMP inspectors who provide the oversight of drug products through domestic and foreign on-site inspections, paper assessments and risk files. Prior to this, she was the supervisor of the team and began her career in the public service as a GMP inspector in the province of Québec. Prior to joining Heath Canada, 13 years ago, she worked in the Pharmaceutical Industry for over 15 years, having held various management positions including continuous improvement, quality assurance and validation.
Viorel Buculei, M.Sc., MBA
Associate Director Quality
Jubilant DraxImage Inc., dba Jubilant Radiopharma
Viorel Buculei currently holds the position of Associate Director, Quality Control at Jubilant Radiopharma and has more than 20 years of experience in the pharmaceutical industry. He has spent more than 15 years in various Quality Control leadership roles in global pharmaceutical organisations and has strong quality expertise in Quality Control, Quality Assurance, Compliance and Quality Systems. He possess in-depth knowledge of the local and international pharma industry practices, standards and applicable regulations to sterile and non-sterile pharmaceutical drug products, radiopharmaceuticals, natural health products, dietary supplements and medical devices.
Viorel has also several years of experience in academic research and has published multiple scientific articles on synthesis of cisplatin derivatives with potential antitumor properties.
Through his various roles in Quality control, Viorel has conducted and approved more than 5000 OOS investigations and has a demonstrated record of successful melding the compliance requirements with the efficiency and business needs through pragmatic use of quality risk management.
Viorel received his Masters of Science degree in chemistry from University of Quebec in Montreal and he holds an executive MBA from University of Quebec in Montreal and an executive MBA from University of Paris Dauphine, France.
David L. Chesney, MSJ
Principal & General Manager
DL Chesney Consulting LLC, Former FDA
DAVID L. CHESNEY, MSJ, is the Principal and General Manager for DL Chesney Consulting, LLC, Cumberland Foreside, Maine, providing GMP and GCP compliance consulting and training services to clients worldwide. Previously he served for over 20 years as Vice President and Practice Lead, Strategic Compliance Services, for Parexel Consulting. Prior to joining Parexel Consulting, he served 23 years with the FDA as an Investigator, Supervisory Investigator, Director of Investigations and ultimately as District Director in San Francisco, managing all FDA’s compliance operations in Northern California, Nevada and Hawaii.
Mr. Chesney has an MS in Jurisprudence (Pharmaceutical and Medical Device Law) and a certificate in Health Care Compliance from Seton Hall University School of Law, a Bachelor’s degree in Biology from California State University, Northridge, and completed three years of graduate study in Biology at CSU Northridge and CSU San Diego. Mr. Chesney is a member of PDA, where he serves on the faculty of the PDA Training and Research Institute. He is a member of the Food and Drug Law Institute, where he serves as volunteer faculty for FDLI’s continuing education programs for the legal profession.
Corinne Cleary, BCompSc
Product Specialist: Technical Processes and Innovation
Novatek International
Over 20 years in the Medical and Pharmaceutical domain with experience in training and defining user requirements with a focus on technical processes and innovation.
Emily Dickinson, MS, ASQ CQA
Associate Director, Quality Assurance
Linical Americas
With nearly 20 years in pharmaceutical manufacturing and clinical research, Emily has run the gamut of Quality roles – from working as a QC Chemist, to heading up Stability Programs and supporting clinical manufacturing, and finally to overseeing Quality Assurance activities at two global contract research organizations where she focused on oncology research. She has worked with a wide variety of drug delivery mechanisms including combination products, oral dosage forms, sterile injectables, and biological products across all phases of development and commercialization. Emily is a relentless champion for Quality and building it into processes and procedures from beginning to end in an effort to instill the Patient First mentality in her teams and organizations.
Emily received her Bachelor of Science degree in Chemistry from Wilmington College in Wilmington, Ohio and her Master of Science degree in Quality Assurance and Regulatory Affairs from Temple University School of Pharmacy. She now resides on Oak Island in North Carolina and enjoys golfing, running, playing with her rescue pup Theodore, and volunteering with the Oak Island Sea Turtle Protection Program.
STUART DU KAMP, BSC (HONS), CCHEM MRSC, PCHEM
Senior Director, Quality Assurance
Cencorae
Innomar Strategies Inc
In his present role as Senior Director, Quality Assurance, Stuart leads the quality assurance function at Innomar, with quality oversight over 3PL / importation, specialty logistics, Patient Support Programs, Innomar Specialty Pharmacies, and Nursing and Clinics. Stuart also leads a team of seasoned quality assurance professionals providing consulting services across the full range of pharmaceutical platforms. Stuart brings over 35 years of experience in the pharmaceutical industry, including over 25 years in Quality Management, 12 years within CMO organizations, and specific experience within the API, sterile, biotechnology, pharmaceutical and medical device sectors. He has a demonstrated record of successfully melding quality compliance with business goals, leveraging his extensive expertise in quality risk management. Stuart has served on a number of industry working groups and has developed a reputation as an ‘ideas’ guy, and an innovator, who thrives in environments that demand pragmatic, cost effective and timely solutions to complex problems. Stuart’s previous companies include SmithKline Beecham (UK), Raylo Chemicals (Gilead), QSV Biologics, Septodont and TPIreg.
MATHIEU D. FOURNIER, M.Sc.
Chef Scientifique / Chief Scientific Officer (CSO)
Neopharm Labs
Mathieu Fournier presently serves as Chief Scientific Officer at Neopharm Labs. This challenging role allows him to apply his global knowledge and expertise of analytical chemistry in the pharmaceutical industry to meet the evolving business demands of various customers from the life sciences industry.
Mathieu has over 20 years of experience in applied research & development within the pharmaceutical industry. Over the course of his career, he managed the development & validation of methods to support routine testing, risk assessments and various studies required for NDA/ANDA submissions and post-commercial support. He is also experienced in providing answers to health authorities as a subject matter expert for several types of dosage forms such as tablets & capsules, ophthalmic solutions and injectable products.
Mathieu’s speciality in mass spectrometry brought him to develop lines of analytical services to support technical issues related to elemental impurities, extractables & leachables and genotoxic impurities. In his current role he is expanding his ability for strategic implementation of new services to multiple fields of expertise, such as biopharmaceutical drug product testing.
Mathieu holds a Master of Science degree in Analytical Chemistry, specializing in small molecule analysis by LC/MS from the Université du Québec à Montréal (UQÀM).
Meg Gallwitz
VP, Quality and Compliance
The Henrici Group
Meg Gallwitz is a quality and compliance leader with over 30 years’ experience across sectors and products within the life science industry; including pharma, biotech, medical device, cannabis, and consumer healthcare. Meg has special expertise in Good Manufacturing Practices and leading the design and operation of Quality Management Systems (QMS) to enable compliance, quality, and continuous improvement. Her passion for the QMS is furthered by the understanding that a modernized, robust, and interconnected QMS is also the foundation for innovation and the adoption of rapidly evolving technologies.
Hank Karayan
Global Head of Cosmetics and Pharma
SGS
Hank Karayan is Global Head of Cosmetics and Pharma at SGS. He started his career in pharmaceuticals and cosmetic ingredients, then moved to GMP, quality and food safety consulting and training, while acquiring academic and hands-on experience in strategic management. Hank holds a Bachelor of Science in Biology and an MBA. He has led multiple projects for multinational firms, SMEs and regulatory bodies in various geographies and held management positions within regional and Global companies prior to joining SGS. With numerous published papers and extensive experience lecturing on global stages, Hank is a recognized expert in GMP and FDA regulations
Kir Henrici
CEO, The Henrici Group (HG)
Kir Henrici, CEO, The Henrici Group (HG), has been consulting domestically and internationally for 13 years in support of quality and compliance, with specialized focus and expertise in the area of Digital Transformation, Quality Culture and organizational change, Quality Management Systems (QMS), and Data Governance/Data Integrity Assurance. Kir has gained global and diverse perspective and working knowledge of quality, compliance and technical challenges and solutions impacting companies around the world, supporting a range of initiatives including tactical change in the area of Quality Culture, QMS design and remediation, and global/site data governance programs.
Kir is a member of PDA and ISPE, and currently serves as a member of the PDA Regulatory Affairs/Quality Advisory Board (RAQAB). Kir is also the co-lead for the PDA “Big Data” task force and PDA Data Integrity Interest Group and is currently co-leading the PDA team submitting comments in response to the FDA Discussion Paper: Artificial Intelligence in Drug Manufacturing.
Kia Kahhali
Founder and CEO
APS Compliance Consultants Inc.
With over 20 years of experience in the Pharma industry, Kia has accomplished to build himself a unique profile. This was achieved by tying his electronics engineering and software development background to GMP Computer System Validation and Analytical Instrument Qualification and Management.
With the technical knowledge of main CDS solutions in the market, business processes, and successful records of CDS validation, he is actively working as a reliable resource for many companies looking for selection, implementation, and validation of Chromatography Data Systems.
Matt Peplowski, M.S.
Founder
BioPharma Error Prevention Associates, Inc.
Matt Peplowski, M.S. is the founder, owner, and principal consultant at BioPharm Error Prevention Associates, Inc. (www.bepa-inc.com). He has over 30 years of GMP Manufacturing, Quality, and Learning & Development leadership experience at large and small, commercial and clinical biopharm companies. Matt has helped numerous companies as a leader or consultant by designing and delivering engaging, effective learning solutions, implementing targeted competency-based training frameworks, designing and implementing human error prevention strategies, and more. He is a subject matter expert in L&D, cGMP, Quality Systems, Human Error Prevention, GxP instructions writing, Investigations & CAPA, Data Integrity, and more. He can be reached at mpeplowski@bepa-inc.com and 978-502-9270.
Ofer Yifrach-Stav, BSc, MSc, PhD
Principal Consultant
YS Consulting
Ofer Yifrach-Stav has 15+ years of experience in the pharmaceutical and medical device industry, focusing on compliance, quality assurance and validation aspects. He has a BSc in Biotechnology Engineering and an MSc in Environmental Engineering. Ofer is a Certified Quality Auditor of the American Society of Quality, and an ISO Lead Auditor in ISO 9001:2015, ISO 13485:2016, and ISO 27001:2022. In recent years he has gained expertise in information security by working towards a PhD in Computer Science.
Conference Chair
Alan Golden, MS
Principal
Design Quality Consultants, LLC
Alan has over 30 years of experience in the medical device industry, both in basic research and in quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 16 years as part of diagnostics R&D, he developed recombinant proteins used in diagnostics tests, received three US patents and published numerous papers and abstracts. Alan then transitioned to a quality assurance role where in both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support and operations.
Alan’s quality assurance experience extends from design control, change control, risk management, CAPA, process and test method validation and statistics. He has been lecturing on these topics worldwide for over 25 years.
Alan retired from Abbott in 2018 and now runs Design Quality Consultants, providing training, workshops and seminars in many areas of quality assurance.
Alan received his BS degree in Microbiology from the University of Michigan and his MS degree in Molecular Biology and Immunochemistry from the University of Illinois.
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