4th Cleaning Validation Conference

Event Details
Head Validation
Novartis AG
ERT, PhD, MSCTox
Aesti
Senior CQV CAPEX Project Engineer
LONZA
Senior GMP Consultant
Passion4Quality
Independent Pharmaceutical Consultant
Borer Chemie AG
EMEA Training Manager & Critical Environments Specialist
DuPont de Nemours
Head of Global Quality Assurance Chemical APIs
Bayer AG
Principal Process Validation Consultant
ValSource Inc.
Business Development/Chair – ASTM E55.11 Process Design
Rattiinox
Managing Toxicologist
SafeBridge Europe

The 4th Cleaning Validation Conference, taking place on 24–25 March 2027 in Barcelona, Spain. Over two days, leading pharmaceutical manufacturers, regulators, and industry experts will explore the latest advances in science- and risk-based cleaning validation throughout the product lifecycle. The program will cover regulatory expectations, Health-Based Exposure Limits (HBELs), Contamination Control Strategy (CCS), equipment cleanability, analytical technologies, digitalization, and practical implementation of lifecycle cleaning validation. Through real-world case studies and interactive discussions, participants will gain practical solutions to strengthen compliance, improve operational efficiency, and prepare for future regulatory challenges.

Subject 1 – Strategy, Science & Regulatory Expectations

  • Regulatory Updates, Inspection Trends & Recent Findings in Cleaning Validation
  • Risk-Based Cleaning Validation & Quality Risk Management Throughout the Lifecycle
  • HBEL/PDE in Practice: From Toxicological Assessment to Cleaning Limits
  • Advanced HBEL Strategies for ADCs, Oligonucleotides, Biologics & New Modalities
  • Cleaning Validation as a Key Element of Contamination Control Strategy (CCS)
  • Scientific Worst-Case Product & Equipment Selection
  • Equipment Design, Cleanability & Hygienic Engineering
  • AI, Digitalization & Data-Driven Cleaning Validation

    Subject 2 – Practical Implementation & Continuous Improvement

  • Cleaning Process Development, Optimization & Validation
  • Risk-Based Sampling: Swab, Rinse, Visual Inspection & Analytical Methods
  • Visual Inspection: Establishing and Defending Scientifically Justified Limits
  • Continued Cleaning Verification, Lifecycle Monitoring & Revalidation
  • Deviations, Investigations & CAPA: When Cleaning Validation Fails
  • Cleaning Highly Potent Compounds in Shared and Multi-Product Facilities
  • Defending Cleaning Limits and Validation Strategies During Inspections
  • Regulatory Case Studies, Inspection Findings & Lessons Learned

    Who Should Join

    Cleaning Validation & Lifecycle Professionals
    Professionals responsible for the development, execution, maintenance and continuous improvement of Cleaning Validation programs across pharmaceutical, biotechnology, sterile manufacturing, ATMP and vaccine production facilities.

    Quality, Validation & Regulatory Experts
    Professionals from QA, QC, Validation, Regulatory Affairs, Compliance and Analytical Development responsible for regulatory alignment, inspection readiness, analytical strategies and robust Cleaning Validation programs.

    MS&T, Engineering & Technical Specialists
    Experts from MS&T, Engineering, Technical Services, process development and automation, as well as equipment manufacturers, responsible for equipment cleanability, process optimization, technology transfer and lifecycle performance.

    CCS, Microbiology, Toxicology & QRM Professionals
    Specialists involved in Contamination Control Strategy (CCS), Quality Risk Management (QRM), Microbiology, Environmental Monitoring, Industrial Hygiene, Occupational Toxicology and HBEL/PDE assessments.

    Manufacturing, Operations & Site Leaders
    Production managers, site leaders, facility and plant management professionals responsible for manufacturing systems, operational controls, cleaning performance, contamination prevention and product quality.

    Project Leaders, CMO/CDMO & Consultants
    Project managers, CMO/CDMO representatives, consultants and decision-makers seeking practical solutions, regulatory insights and innovative technologies to improve Cleaning Validation efficiency, compliance and inspection readiness.

  • 2 days access
    Original price was: €1,099.Current price is: €599.
  • Full Access
  • Post-event documentation
  • Certificate of attendance
  • Recording
  • 4th Cleaning Validation Conference
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