Meet our Experts.
Industry leaders. Inspiring educators.
Learn from the best. Our instructors are seasoned professionals with years of hands-on experience in their fields. They combine deep industry knowledge with a passion for teaching, guiding you through practical insights and real-world skills that empower your professional growth.
Each course is designed and led by experts who stay at the forefront of industry trends, ensuring that what you learn is relevant, up-to-date, and immediately applicable. With their mentorship and guidance, you’ll gain the confidence, tools, and perspective to advance your career and make a real impact in your field.
Learn from the Best
Prof. David Stepensky
Head of Pharmacy School and leading researcher in pharmacokinetics and drug delivery.
Advisor to regulators and pharma innovators worldwide.
Areas of expertise: • Pharmacokinetics & Pharmacodynamics • PK–PD Modeling • Drug Delivery Systems • Preclinical & Clinical Development • Pharmaceutical R&D
Dr. Ilan Volovitz
Senior immunology researcher and FACS technology specialist.
Advisor to biotech companies across the full product development lifecycle.
Areas of expertise: • Flow Cytometry (FACS) • Immunology and Cancer Research • Translational R&D • Biotechnology Product Development • Biomedical Research Strategy
Mike Zaavi
Senior consultant in software validation and regulatory IT compliance.
Expert in 21 CFR Part 11, Annex 11, and quality systems for biomedical software.
Areas of expertise: • Computerized Systems Validation (CSV) • Software Quality Assurance • 21 CFR Part 11 & Annex 11 • Regulatory IT Compliance • Biomedical and Clinical Systems
Dr. Ofer S. Dubinsky, Ph.D.
Senior consultant and former pharmaceutical executive with deep QC and CMC expertise.
Founder of Bio-Pharm Knowledge and long-standing industry lecturer.
Areas of expertise: • Pharmaceutical Quality Control • CMC & Analytical Sciences • Biotechnology Manufacturing • Regulatory Affairs & Due Diligence • Professional Training & Education
Karen Taylor (Ginsbury)
International GMP and quality systems consultant with decades of industry leadership.
Renowned lecturer and advisor in regulatory compliance and inspection readiness.
Areas of expertise: • GMP Compliance • Pharmaceutical Quality Systems • Regulatory Inspection Readiness • CMO and Supplier Audits • FDA and EU Regulatory Standards
Dr. Michael Zviely
Senior R&D and innovation executive with global industrial and academic impact.
Expert in flavors, fragrances, aroma chemistry, and bio-based technologies.
Areas of expertise: • Flavors and Fragrances Innovation • Aroma and Specialty Chemicals • Advanced R&D Leadership • Bio-Based and Sustainable Materials • Technology Commercialization
Dr. Bianca Avramovitch, Ph.D.
Global leader in pharmaceutical analytical R&D and regulatory science.
Former senior executive at Teva and USP expert committee member.
Areas of expertise: • Pharmaceutical Analytical R&D • Advanced Analytical Technologies • USP Standards & Monographs • Global R&D Leadership • Regulatory & Data Integrity Systems
Iris Leinwand
Senior consultant in medical device quality and global regulatory compliance.
Expert in ISO 13485, EU MDR/IVDR, FDA QSR, and sterilization validation.
Areas of expertise: • Medical Device Quality Systems • Global Regulatory Compliance • ISO 13485 & MDR/IVDR • FDA & MDSAP Readiness • Sterilization Validation and Auditing