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Cleaning Process & Validation Conference

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Theresa Ladwig, CH
Strategic Product Manager
Skan AG
Igor Gorsky, US
Principal Process Validation Consultant
ValSource Inc.
Richard Denk, CH
Senior Consultant, Aseptic Processing & Containment
SKAN
Ravi Moorthy, SG
President
Quascenta Pte Ltd
Andrew Walsh, US
President
Center for Pharmaceutical Cleaning Innovation (CPCI™)
Faidra Angelikaki, GR
Group Quality Product & Process Validation Manager
COMPASS by FAMAR
Fabio Buscaglia, IT
Area Manager Europe Pharmaceutical Cleaning Solutions
IWT s.r.l.
David Val, UK
Business Development Manager EMEA
ILC Dover
Varadharaj Vijayakumar, DE
Senior Subject Matter Expert-Aseptic Fill Finish/Freeze Drying
WuXi Biologics
Cecilia Pierobon, DE
Technical Service Manager
STERIS Life Sciences
Thomas Altmann, DE
Technical Consultant and Validation Manager
ECOLAB
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 to you the Cleaning Process & Validation Conference in Munich, Germany & Online on 7-8 November 2024. This conference will focus on aspects of pharmaceutical manufacturing hygiene, CIP/COP advantages, and cleaning validation. Learn from a recent industry case where a manufacturer’s oversight led to scrutiny for lacking written instructions and neglecting cleaning validation.

Join experts as they guide you through crafting a robust cleaning validation plan, covering essential elements such as strategy, procedures, protocols, and timelines. Explore the impact of risk assessment on product quality, gaining valuable insights into industry best practices. Take part in interactive discussions and query solvent sessions by securing your spot by submitting the request.

Our Focus

  • Annex 1 and New Cleaning Practices
  • Comprehensive Risk-Based Approach
  • Effective Risk Analysis and Evaluation
  • CIP/COP, and SIP/SOP
  • CCS (Contamination Control Strategies)
  • Practical Cleaning Process Development
  • Robust Cleaning Control Strategies and Compliance
  • Optimized Sampling Techniques and Analytical Methodology Expertise
  • Commodity of New Cleaning Agents
  • Digitalization and Optimization of Cleaning Process

    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, sampling methods, analytical detection method validation, limits determination, and strategic approaches for managing multi-product facilities.
  • Professionals encompassing the entire life cycle of product development and commercialization, individuals from diverse backgrounds eager to broaden their understanding of cleaning validation and related pharmaceutical processes, and experts dedicated to monitoring and ensuring the safety of pharmaceutical products.
  • Developing laboratory studies for worst-case soiling analysis and selection of cleaning agents
  • Performing developmental studies for swab, rinse, and visual inspection methods
  • Understanding the dynamics of manual cleaning, COP, and CIP processes
  • Performing cycle development runs to optimize cleaning procedures
  • Establishing residues and limits for actives and biologics

    • Speakers:
  • Perspective on the use of solubility, cleanability and toxicity for the selection of the worst-case product
  • Laboratory coupon studies to support in the selection of the worst-case product
  • Case studies about the implementation of a product grouping approach using laboratory cleanability data
  • Equipment Grouping as a key element of a product-grouping approach

    • Speakers:
  • Points to consider if paper based cleaning process documentation is still used
  • Digitalization of Operating procedures, logbooks, and critical cleaning process parameters
  • Ongoing verification of cleaning process
  • Why is optimisation often much easier after digitalization?

    • Speakers:
  • Why digitalization can be a challenge many times in Cleaning Validation
  • Residue Limits and product grouping - Why is it a challenge even after 30 years
  • Utilizing Visual Residue Limit as Part of Routine Monitoring

    • Speakers:
  • Annex 1 is clear about the Validation of the Cleaning for all surfaces during aseptic manufacturing
  • What are high potent products and how should surfaces be cleaned to protect the operator and prevent cross contamination

    • Speakers:
  • Disinfection/sanitization rotational program in cleanrooms
  • Requirements for Cleaning and Sanitization programs in aseptic areas in compliance with regulations (EU Annex 1 and FDA)
  • bValidation Strategy (Clean in Place) for Lyophilizers
  • Validation Strategy (Clean in Place) for product contact surfaces and isolators
  • Regulatory observations related to cleaning and sanitization programs

    • Speakers:
  • Why did the title change (from "Points to Consider for Cleaning Validation" to "Science and Risk-Based Approach for Cleaning Validation")?
  • Review of Major Changes – Enhancement of the Science and Risk-Based Approach
  • The Role of Visual Inspection in the Enhanced Approach
  • What are the major regulatory guidance that support the new approach?

    • Speakers:
  • 30-mins Speaking slot
  • Brand awareness via Social Media
  • Ad 1/4 page placed in the agenda
  • Logo on the Agenda
  • All attendee's benefits
  • Critical considerations for developing a successful Cleaning Validation program in diverse CDMO environment
  • Mastering multi-product challenges through real case examples
  • Advantages of Risk-based strategies for a successful Cleaning Validation program
  • Advanced Cleaning Validation lifecycle

    • Speakers:
  • Why are Risk-Based Cleaning Standards needed?
  • Importance of ASTM Cleaning Standards
  • The Quantitative Measurement of Risk in Cleaning and the Shirokizawa Matrix
  • The "Cleaning Assurance Level"

    • Speakers:
  • What are the challenges when introducing a hazardous product into an existing facility?
  • How to use QRM to identify hazards?
  • How to use QRM to determine acceptable CV limits?
  • How to use QRM to identify sampling locations and the number of runs?
  • What is the role of CV in verification of effectiveness of process controls?
  • How to define the frequency of ongoing process verification based on QRM & historical data?

    • Speakers:
  • Traditional CIP cleaning development relied on coupon and riboflavin tests, often overlooking cleanability issues
  • Clean by Design offers simple strategies to enhance cleanability, streamlining cleaning processes
  • It aims to boost operational efficiency, increase manufacturing capacity, and reduce waste
  • Already embraced by members of ASTM E55.11 review group, it promises to improve OEE and sustainability
  • It's set to influence future decisions on equipment expenditures for large-scale production

    • Speakers:
  • Key points of the legislation
  • Computer systems and data integrity
  • Some practical examples of how regulatory updates have been received by the market

    • Speakers:
  • 30-mins Speaking slot
  • Brand awareness via Social Media
  • Ad 1/4 page placed in the agenda
  • Logo on the Agenda
  • All attendee's benefits
  • Contamination Control Strategy
  • Overview Contamination Control Plan
  • Contamination Control Countermeasure
  • Cleaning and Disinfection for Decontamination Surfaces
  • Environmental Monitoring (EM) for Contamination Monitoring
  • Hygiene of Personnel – Cleanroom Behavior

    • Speakers:
  • Calculation of PDEs
  • PDEs for compounds with limited data
  • PDEs and regulatory requirements
  • PDEs and cleaning validation

    • Speakers:
  • The critical role of flexible single-use containment systems in meeting Annex 1 guidelines for sterile pharmaceutical manufacturing
  • Exploring the benefits such as reduced contamination risk, enhanced flexibility, simplified cleaning and validation, improved operator safety, and cost efficiency
  • Demonstrates how adopting disposable containment solutions can optimize manufacturing processes, ensure product integrity, and effectively meet regulatory standards

    • Speakers:
    €1,499
    2 Day Access
    Register Today
  • Full in-person
  • Refreshment breaks
  • Post-event documentation
  • Certificate of attendance
  • Networking Cocktail
    • €1,199
    Online Access
    2-Day Online Access
  • Full online access
  • Post-event documentation
  • Certificate of attendance
    • Cleaning Process & Validation Conference
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