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3rd Cleaning Validation & CCS Conference

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Ulrike Baumgärtner, DE
Senior GMP Consultant
Passion4Quality
Valentine Krug, BE
Manager, Technical Services
STERIS Life Sciences
Steve Marnach, LU
EMEA Training Manager & Critical Environments Specialist
DuPont de Nemours
Igor Gorsky, US
Principal Process Validation Consultant
ValSource Inc.
Faidra Angelikaki, GR
Group Quality Product & Process Validation Manager
FAMAR
Fabio Buscaglia, IT
Senior Engineering Pharmaceutical Cleaning Solutions
IWT s.r.l.
Varadharaj Vijayakumar, DE
Associate Director – Manufacturing (Aseptic Fill-Finish)
Terumo
Morcos Loka, EG
MBA, CMQ/OE, CQA, CPGP, CPIP
Minapharm
Richard Hall Hall, ES
Business Development/Chair – ASTM E55.11 Process Design
Rattiinox
Dr. Martin Kohan, UK
Managing Toxicologist
SafeBridge Europe

Speak Pharma presents the 3rd edition, taking place in Vienna, Austria, and online on November 10–11, 2026. Industry leaders will examine Contamination Control Strategy (CCS) from a cleaning-validation perspective, focusing on how residue control, equipment cleanability, and lifecycle cleaning validation directly support a robust CCS under Annex 1. The program includes practical approaches for linking cleaning validation limits to contamination-control decisions, integrating analytical and microbiological data into CCS assessments, and improving risk-based control measures in multi-product operations. Through real-world case studies and guided discussions, participants will gain clear, actionable insights to strengthen their cleaning-driven CCS programs. Secure your spot now by submitting a request.

Subject 1 – Strategy & Regulatory Alignment

· Case-Based Approach and Evaluation of Recent Warning Letters
· Evolution of Cleaning Validation under Annex 1
· Regulatory and industry expectations in practice
· Building a risk-based CCS framework
· CCS implementation in multi-product facilities
· Digital tools for CCS monitoring and data integrity
· Linking cleaning validation to CCS risk matrices

Subject 2 – Implementation & Continuous Improvement

· Best practices in cleaning validation lifecycle
· Sampling and analytical methods
· Integrating environmental and microbiological controls into CCS
· Human factors and operator behaviour in contamination control
· Audit-ready documentation and CAPA integration
· Future direction of cleaning validation under Annex 1

Who Should Join

Professionals overseeing the full lifecycle of cleaning validation programs—from development through implementation and ongoing maintenance—across pharmaceuticals, biotechnology, vaccines, and sterile manufacturing, including integration within a site-wide Contamination Control Strategy (CCS).

Experts in quality assurance and control (QA/QC), microbiology, chemistry, analytical development laboratories, regulatory affairs, compliance, validation, and internal/external audit, responsible for ensuring regulatory alignment (including Annex 1), contamination control, and product quality.

Leaders and technical specialists from Manufacturing Science & Technology, process and formulation development, CMC, technology transfer, external supply, CMO/CDMO management, and packaging, accountable for evaluating cleaning systems, equipment design, cleanability, and practical execution of cleaning validation and CCS elements.

Decision-makers and strategic leaders in operations, plant management, business and strategic development, licensing, commercialisation, and new product introduction, seeking a deeper understanding of the science behind cleaning and cleaning validation, including residue selection, risk assessment, and their impact on CCS robustness.

Professionals involved in environmental monitoring, microbiological oversight, industrial hygiene, occupational and corporate toxicology, drug safety evaluation, and HSE/EHS, contributing critical data and risk-based insight to contamination control and CCS decision-making.

Engineering, production, sterilisation, process monitoring and control, and continuous processing personnel responsible for facility design, equipment configuration, process flow, and operational controls that enable effective contamination control and validated cleaning processes.

  • How to use quality risk assessment to define the required technical and procedural controls
  • How to evaluate the effectiveness of these controls
  • How these controls can be reflected in different elements of the contamination control strategy

    • Speakers:
  • Key sections and structure of a PDE report
  • Scientific rationale and data requirements
  • Selection of the Point of Departure (POD) and uncertainty factors
  • Use of AI to support toxicological hazard identification

    • Speakers:
  • Expectations under the 2022 EU GMP Annex 1
  • Application of Quality Risk Management (QRM) to cleanroom garment systems
  • Structured, science-based assessment and qualification of cleanroom garment systems to achieve compliance

    • Speakers:
  • Defines IBC cleaning as a CCS preventive control
  • Identifies contamination risk drivers (potency, design, residues)
  • Applies risk-based cleaning stringency and acceptance criteria
  • Designs cleaning processes to maintain contamination control
  • Controls critical steps where loss of containment may occur
  • Uses cleaning validation to verify CCS effectiveness

    • Speakers:
  • Annex 1 expectations for minimizing human intervention within a documented Contamination Control Strategy (CCS)
  • Design and operational best practices to reduce human-dependent contamination risks
  • Common regulatory observations and practical lessons learned to strengthen CCS effectiveness
  • Risk-based selection of sterilization and decontamination approaches for material transfer systems
  • Material transfer as a critical intervention point affecting aseptic process integrity
  • Use of No-Touch Transfer (NTT) technologies to eliminate glove, door, and surface contact

    • Speakers:
  • Definition of Rouging and classification
  • Causes of rouging
  • Best practices for SS maintenance
  • Routine cleaning with Acids and their gaps to maintain stainless steel
  • Risk-based approach strategy-based for indirect and direct product contact parts

    • Speakers:
  • This presentation provides practical insights into critical pitfalls across the entire lifecycle of cleaning validation. It addresses typical challenges related to the definition of the validation strategy, documentation, worst-case selection, acceptance limit calculation, and the transfer of validation outcomes into routine operations. Particular focus is placed on post-cleaning situations, where the validated state can be unintentionally weakened by organisational, technical, or procedural shortcomings.
  • Using real-life GMP examples, the presentation illustrates why these pitfalls are relevant for the successful completion of cleaning validation within a reasonable timeframe, as well as for inspection readiness.
  • The aim of this presentation is to provide experience-based orientation on where cleaning validation programmes tend to lose robustness and efficiency in practice – and how these risks can be proactively addressed through clear strategy, risk-based thinking, and pragmatic GMP decision-making.

    • Speakers:
  • Equipment is designed using outdated “rules of thumb” that allow “cleaning hazards” such as dead legs, crevices in components, shadowed areas, etc. This presentation will highlight some of these, with simple solutions
  • There is currently no requirement to highlight such “cleaning hazards” on engineering and vendor documentation (P&IDs, layouts, etc.), so it is difficult to conduct cleaning risk analysis, decide which “hardest-to-clean” areas need to be more thoroughly checked during FAT (factory acceptance testing), validate the cleaning process in those same areas, and finally decide which of those areas require continued cleaning process verification at change of batch or product — or manual cleaning
  • Cleaning and cleaning validation SMEs have, under pressure to start production, developed COP cleaning processes to overcome equipment cleaning hazards. These cleaning processes are then “set in stone” for the next facility, rather than simply improving the equipment design to avoid the cleaning hazards. Why not treat the disease instead of the symptom?
  • The same SMEs have experience with CAPAs and deviations, and maintenance regularly finds residues. Why not involve all this in-company knowledge to improve the new facility, instead of continuing to allow large engineering companies to copy/paste facilities from decades ago?
  • There is growing support for the idea of creating the role of “Cleaning System Owner, from Conception to Grave” rather than the current Cleaning Validation lifecycle of “Cradle to Grave.” This role would have not just responsibility, but also authority (somewhat like a Qualified Person)

    • Speakers:
    Original price was: €1,499.Current price is: €899.
    2 day Access
    Early Bird
  • Full in-person
  • Refreshment breaks
  • Post-event documentation
  • Certificate of attendance
  • Networking Dinner
    • Original price was: €2,999.Current price is: €2,099.
    Group Booking 3
    3 Delegates Attendance
  • Full in-person
  • Refreshment breaks
  • Post-event documentation
  • Certificate of attendance
  • Networking Dinner
    • Original price was: €3,999.Current price is: €2,799.
    Group Booking 4
    4 Delegates Attendance
  • Full in-person
  • Refreshment breaks
  • Post-event documentation
  • Certificate of attendance
  • Networking Dinner
    • Original price was: €4,999.Current price is: €3,499.
    Group Booking 5
    5 Delegates Attendance
  • Full in-person
  • Refreshment breaks
  • Post-event documentation
  • Certificate of attendance
  • Networking Dinner
    • 3rd Cleaning Validation & CCS Conference
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