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2nd Cleaning Process & Validation Conference

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Susan B. Cleary, CA
Director of Product Development, B.Cs, EMBA
Novatek International
Lukáš Dvořák, MSc, CZ
Independent Pharmaceutical Consultant
Borer Chemie AG
Lilia Lahouel Lefebvre, CH
Cleaning Validation Manager
Skan AG
Dr. Thomas Adam, DE
Head of Global Quality Assurance Chemical APIs
Bayer AG
Igor Gorsky, US
Principal Process Validation Consultant
ValSource Inc.
Ravi Moorthy, SG
President
Quascenta Pte Ltd
Faidra Angelikaki, GR
Group Quality Product & Process Validation Manager
COMPASS by FAMAR
Fabio Buscaglia, IT
Senior Engineering Pharmaceutical Cleaning Solutions
IWT s.r.l.
Varadharaj Vijayakumar, DE
Associate Director – Manufacturing (Aseptic Fill-Finish)
Terumo
Cecilia Pierobon, DE
Technical Service Manager
STERIS Life Sciences
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 2nd edition, scheduled in the beautiful city of Prague, Czech Republic, and online on November 19-20, 2025. Industry leaders will explore critical aspects of safe pharmaceutical manufacturing, “equipment design for rapid and robust CIP (Clean in Place) cleaning, practical standards in cleaning validation, and more. Part of the conference program will include in-person training by Igor Gorsky on ASTM standards. Gain insights from real-world cases and expert guidance on developing robust cleaning validation plans, applying the QRM approach to cleaning, and understanding how risk assessments impact product quality. Participate in interactive discussions to enhance your knowledge and practices. Secure your spot now by submitting a request.

Our Focus

  • Impact of Annex 1 on Cleaning Validation
  • QRM Approach in Cleaning
  • Maintaining Risk Analysis and Evaluation
  • Equipment Designed for Cleanability
  • Practical Cleaning Process Development
  • Robust Cleaning Control Strategies and Compliance
  • ASTM Standards to Support Cleaning Process and Validation
  • Sustainability and Resource Efficiency
  • Digital Transformation and Data Integrity
  • Cleaning Validation in HPAPI Manufacturing Facilities
  • Cleanroom Cleaning Validation

    Who Should Join

    Professionals overseeing the entire spectrum of cleaning validation programs, from initial development to seamless deployment and ongoing maintenance.
    Experts in quality assurance, quality control, and regulatory affairs playing pivotal roles in ensuring compliance and quality standards.
    Leaders and technical experts responsible for the evaluation of cleaning systems, equipment review, and robust support for on-the-ground implementation of the cleaning validation program.
    Decision-makers at every level seeking a profound understanding of the science behind cleaning and cleaning validation. This includes considerations like residue selection.

    Request the program.

  • GMP Compliance and Regulatory Environment – Current Guidelines for HPAPIs, Cleaning, and
    Cross-Contamination

  • Prevention of Cross-Contamination – A Systematic Approach within Chemical Development (Examples)
  • Cleaning of Equipment in Shared Facilities Manufacturing HPAPIs (Concepts & Examples)

    • Speakers:
  • Understand Global Regulatory Requirements
  • Identify Common Compliance Gaps
  • Implement Effective Cleaning & Disinfection Programs
  • Disinfectant Qualification and Rotation Strategy

    • Speakers:
  • The Most Frequent Observations Within Cleaning Procedures
  • Is Your Equipment Really Clean After Cleaning Procedure?
  • Tips and Tricks Applied as CAPAs

    • Speakers:
  • Cleaning”, As It Is Described In Annex 1
  • Microbial Considerations For The Cleaning Processes
  • Disinfection And Sanitization Practices
  • Disinfection And Sanitization Effectiveness Prerequisites And Programs
  • Review Of The Regulatory Observations For Lack Of Cleaning And Disinfection Programs

    • Speakers:

    Gain Insight into Digital Cleaning Validation Workflows

  • Understand how digital platforms streamline and standardize the cleaning validation process—from data capture to reporting

    Automate Worst-Case Scenario Calculations

  • Learn how digital tools can be configured to assess worst-case residue conditions using customizable, validated equations

    Implement Risk-Based Change Management

  • Evaluate and document the risk of changes (e.g., new products, equipment, or procedures) using digital frameworks that support regulatory compliance

    Calculate Maximum Allowable Carryover (MAC)

  • Discover how digital tools enable accurate, automated MAC calculations for APIs, cleaning agents, and residues in line with regulatory standards

    Enhance Data Integrity and Audit Readiness

  • See how digitalization improves traceability, reduces human error, and ensures data integrity to support regulatory expectations and inspection readiness

    • Speakers:
  • Regulatory Guidance – Review Of Regulatory Basis For Specifications
  • What Can Our Cleaning Processes Support And Why?
  • What Can We Expect From Regulators And Why (Review Of The Regulatory Observations)?
  • How Cleaning Of Indirect Product And Non-Product Contact Surfaces Fits Into Contamination Control Strategy As Discussed In Annex 1

    • Speakers:
  • Lifecycle of Indirect and Product Contact Parts in Aseptic Processing
  • Annex 1 Requirements for Cleaning and Sterilization of Indirect Product Contact Parts
  • Common Cleaning Challenges with Silicone Oil Residues and Their Solutions

    • Speakers:
  • What Is An ADC?
  • Components Of An ADC
  • What Is A PDE?
  • PDEs For Components Of An ADC

    • Speakers:
  • Regulatory Requirements for HPAPI Biomanufacturing Facilities
  • Identifying Cross-Contamination Risks and Mitigating Them to Acceptable Levels
  • Defining a Risk-Based Contamination Control Strategy
  • Incorporating Controls into Process and Facility Design
  • Quantitatively Verifying the Effectiveness of These Controls

    • Speakers:

    Multiuse stainless steel biologics facilities often have low production efficiencies due to:

  • Legacy equipment not designed for easy CIP cleaning
  • Rushed deadlines for developing and validating CIP cleaning processes
  • Impractical subsequent optimization of the cleaning process once validated, due to fear of and perceived loss of production time
    The ASTM E55.11 Clean by Design standard proposes:

  • Involving cleaning process and validation SMEs in equipment specifications
  • Including cleanability objectives in equipment specifications
  • Understanding and avoiding common equipment cleanability hazards
  • Testing equipment cleanability with real or suitable surrogate residues at FAT (Factory Acceptance Test)
    Results:

  • 10-30% production (and capacity) increase with the same or lower CAPEX
  • 50-80% savings in energy-intensive water and chemical usage

    • Speakers:
  • The Construction Quality of Equipment to Reduce Risks in Cleaning Processes
  • Material Requisition or Technical Specifications
  • Technical Comparison with the Supplier
  • Design Qualification (DQ)

    • Speakers:
  • Qualification vs. Validation – Understanding the Difference in Digital Contexts
  • 483 Observations & How Digitalization Can Help
  • Overcoming Challenges When Transitioning from Paper-Based to Digital Validation Tools
  • Software Integration for Seamless Management: Qualification ↔ Process Validation ↔ Cleaning

    • Speakers:
  • Importance of Equipment Design in Cleaning Validation
  • Key Equipment Design Requirements to Ensure Cleanability During Equipment Lifecycle
  • Handling the Induction of New & Second-Hand Equipment Through Real Case Examples
  • Impact of Poor Equipment Design on the Cleaning Validation Lifecycle

    • Speakers:
  • Toxic Cleaning in Isolators – Practices and Efficiency Assessment
  • Operator Protection in Toxic Cleaning – Containment and Airflow Controls
  • Risk-Based Approaches to Toxic Cleaning in High-Containment Areas
  • Best Practices for Safe and Compliant Toxic Cleaning

    • Speakers:
  • Automation of Cleaning Process Development – Uses and Applications (Workshop)
  • ASTM Standards for Science- and Risk-Based Cleaning Validation
  • Using Total Organic Carbon Analysis in Cleaning Validation (Workshop – with Beckman Coulter??)
  • Quantitative Measurement of Risk in Cleaning Pharmaceutical and Medical Devices
  • Qualification of Visual Inspection and Application of Machine Learning (Workshop)

    • Speakers:
    Original price was: €1,999.Current price is: €1,399.
    2 day Access
    Early Bird
  • Full in-person
  • Refreshment breaks
  • Post-event documentation
  • Certificate of attendance
  • Boat Trip with Networking Dinner
    • Original price was: €1,299.Current price is: €1,199.
    Online 2 day access
    Early Bird
  • Full online-access
  • Post-event documentation
  • Certificate of attendance
    • €2,798
    Group Booking 2+1
    3 Delegates Attendance
  • Full in-person
  • Refreshment breaks
  • Post-event documentation
  • Certificate of attendance
  • Networking Dinner
    • 2nd Cleaning Process & Validation Conference
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