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Pharmaed Resources Cleaning Validation Summit 2018

PRESENTERS: Thomas Altmann, Global CIP/COP Technical Manager and Sunil Patel, Sr. Global Technical Manger North America

LOCATION: The Racquet Club of Philadelphia

This two-day intensive summit brings together industry leaders on science, risk and statistics-based cleaning validation to get you started in implementing these 21st Century approaches.

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Cleaning Validation Summit 2018

Are you up to speed on the new Science, Risk and Statistics based approaches for Cleaning Validation? Today’s regulators are now asking for, and expecting, ADE Monographs and Risk Assessments of Cleaning Validation Programs. This two-day intensive summit brings together industry leaders on science, risk and statistics-based cleaning validation to get you started in implementing these 21st Century approaches. These new approaches can reduce the level of effort, formality and documentation of cleaning validation based on risk, streamline the validation work and accelerate the introduction of new products.

The entire team that wrote the new ASTM Standard Guide for Science Based and Risk Based Cleaning Process Development and Validation will be there and presenting!

With comprehensive coverage on:

  • ASTM Standard on Science and Risk-Based Cleaning Process Development and Validation
  • Case Study for Low-Risk Manufacturing
  • ASTM Standard on Derivation of Health Based Exposure Limits (ADEs/PDEs)
  • How to use ADEs/PDEs for Setting Cleaning Acceptance Limits
  • ASTM Standard for Validating Cleaning Processes Used During the Manufacture of Medical Devices
  • Upcoming ASTM Cleaning Standards Covering Both Drugs and Devices
  • Automation for Rapid Cleaning Process Development
  • Application of Risk Assessments to Cleaning Processes
  • Risk-based Selection of Analytical methods
  • Risk-based Implementation of Total Organic Carbon Analysis (TOC)
  • Application and Qualification of Visual Inspection
  • Identification of Unknown Residues Found in Cleaning Validations
  • Statistical Evaluation of Cleaning Validation Data
  • Application of Bayesian Statistics to Cleaning

The Racquet Club of Philadelphia

The Racquet Club of Philadelphia is located in the heart of downtown Philadelphia, adjacent to beautiful Rittenhouse Square. 

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Presenter Bio
Thomas Altmann

Thomas is the Global CIP/COP Technical Manager for Ecolab Life Sciences and has over 18 years of experience consulting for the pharmaceutical, biotechnology, API production and personal care industries specifically related to cleaning, validation and disinfection of product contact surfaces.  For the past 10 years he has managed the Ecolab Cleaning Validation platform which is used by over 800 customers worldwide.  His team has also developed more than 1300 cleaning recommendations for a range of industries over the last 5 years.  Thomas has held workshops and presented at various industry organizations including the Institute of Validation Technology (IVT), ISPE, Informa Life Sciences, VDMA and FDAnews and is an active member of the ASTM E55 WK15778 Cleaning Process Development and Validation group with published articles in Pharmaceutical Engineering, Pharmaceutical Online and Biotechnology Online.

Thomas will be presenting: Practical implementation of the ASTM E3107 in the Pharmaceutical Industry 

In 2011, the FDA published general principles for process validation following a life cycle approach. The pharmaceutical industry has begun to apply these principles to cleaning process validation; however, to fully implement life cycle practices into cleaning process development and validation, the industry’s challenge is to translate the 2011 guidance to a structured, practical, risk-based approach. The ASTM guide E3107 provides the framework and structure for science- and risk-based approaches. This presentation will provide practical guidance on the knowledge and information needed to perform risk assessments that ease cleaning process development and validation efforts. A risk assessment format and examples will be provided.

Sunil Patel
Presenter bio
Sunil patel

Sunil Patel is the Senior Global Technical Manager, North America and has over 12 years of experience working in the engineering and validation fields of cGMP/FDA/EU/ISO regulated industry sectors.  In his role he provides support and guidance around CIP/COP/manual cleaning validation practices in GMP manufacturing operations.  He has a strong background in cleaning validation, process validation, process design, clean utilities, sterilization and processing equipment validation.  Further expertise includes process optimization, regulatory compliance and risk management methodologies for the pharmaceutical and biologics industry. 

Sunil will be presenting: Knowledge and Risk-Based Optimization of Cleaning Validation Programs 
It is a large undertaking for pharmaceutical manufacturers to change decades-old legacy cleaning validation programs. Without known cleaning issues or historical regulatory inspection findings, there is little impetus to change current practice. In most cases, legacy cleaning procedures were developed based on excessive cleaning strategies rather than characterization by scientific data and correlation between critical cleaning performance parameters (CCPP) and their impact on cleaning performance. This presentation will examine a scientific and risk-based cleaning validation program optimization based on ICH Q9 principles and the newly published ASTM E3106 standards. It will outline how scientific data and performance of risk assessments throughout the cleaning validation life cycle can be leveraged to optimize and deliver a compliant and efficient cleaning validation program. Case studies will be shared to demonstrate the time, water, chemistry or energy savings achieved utilizing this approach.