Course Description:

Cleaning validation programs for pharmaceutical firms are a regulatory expectation. The FDA, Health Canada, WHO and other regulatory agencies have published their expectations for a good cleaning validation program. There are also numerous textbooks, articles, and other helpful resources such as PDA’s Technical Report #29 (Revised 2012) “Points to Consider for Cleaning Validation”. The risk-based regulatory initiatives of the FDA focus new attention on the risks of cross-contamination. Some firms have highly potent molecules in their product mix. Advanced analytical methods are emerging with promises to detect molecules to the ppb levels. Understanding and implementing new technologies and principles pause challenges to a cleaning validation specialist to establish, manage and maintain a scientifically sound cleaning validation program.

This two day interactive course will cover fundamental principles of a cleaning validation program, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in various pharmaceutical and biotechnology processes, and establishment of scientific rationales acceptable to regulatory inspectors.

Learning Objectives:

Upon completing this course on cleaning validation, participants will understand:

  • Regulatory requirements for cleaning validation
  • Fundamentals of cleaning validation
  • How to develop master plans
  • SOP development
  • Equipment characterization
  • How to differentiate the requirements for cleaning validation when using manual, semi-automatic, and automatic cleaning technologies
  • How to identify and characterize potential residues including product, process and cleaning agents
  • How to conduct lab scale studies to determine best cleaning conditions
  • Cleaning chemistry and selection of suitable cleaning agents
  • How to validate/qualify analytical and microbiological methods
  • How to perform recovery studies
  • Engineering studies and cycle development
  • How to calculate acceptance limits that meet regulatory expectations
  • Family/grouping approaches for equipment/product
  • How to determine suitable sampling techniques and the selection of sampling locations
  • Developing cleaning validation protocols
  • Collecting and testing validation samples
  • Developing validation reports
  • How to investigate and find root cause for failures
  • Life cycle management and monitoring programs

Attendees will be able to practice through hands-on exercises.

Who will Benefit:

This course is designed for professionals responsible for all aspects of cleaning validation programs, including development, deployment, and maintenance. Following personnel will benefit from the course:

  • Quality assurance specialists
  • Quality control technicians
  • Validation scientists
  • Validation service personnel
  • Production supervisors
  • Manufacturing engineers
  • Design engineers
  • Technical support personnel
  • Engineers supporting the cleaning validation program
  • All levels of management who need to understand the science of cleaning and cleaning validation

Topic Background:

An effective and efficient cleaning validation program makes good business sense for firms, since it saves money in the long run. The cost of not having a sound cleaning validation program may affect the reputation of companies if they have to recall products due to cross contamination which may also mean loss of millions of dollars in revenue.

The FDA and other regulatory agencies want to make sure that firms take all precautions to avoid cross contamination. Implementing principles of a scientifically sound cleaning validation program is one way to ensure cross contamination especially for multiproduct facilities. Firms that are in Consent Decree with FDA know very well the cost of non-compliance.

Course Outline:

Day One(8:30 AM – 4:30 PM) Day Two(8:30 AM – 4:30 PM)

Registration Process: 8:30 AM - 9:00 AM

Session Start Time: 9:00 AM

  • Cleaning Validation Overview
  • Regulatory Requirements for Cleaning Validation
  • Fundamentals of Cleaning Validation
  • Regulatory Observations and Cost of non-compliance
  • Cleaning Validation Master Plans
  • Equipment Characterization
  • Grouping Strategies
  • SOP Development for Cleaning
  • Residues and Limits
  • Developing Acceptance Criteria
  • Test Methods Validation and Recovery Studies
  • Engineering Studies and Cycle Development
    • Lab scale studies
    • Determination of Critical Cleaning Parameters
  • Requirements of Cleaning Validation
    • Manual
    • Semi-automatic
    • Automatic

  • Challenges of Cleaning Validation
    • Multi-product facilities
    • Campaign based productions
    • Clean-in-Place
    • Clean-Out of-Place
  • Specific issues for production facilities
    • API Facilities
    • Animal Health
    • CMOs
    • Biopharmaceutical Facilities
  • Cleaning Validation Protocols
  • Sampling Techniques
  • Protocol Execution
  • Collecting and Testing Samples
  • Failures and Root Cause Investigation
  • Cleaning Validation Reports
  • Post Validation Monitoring Programs
  • Review and discussion of some common FDA 483’s
  • Main ingredients to a good Cleaning Validation Program
    • Tips and pitfalls
  • Getting Ready for a Regulatory Audit
  • Hands on exercises

Meet Your Instructor

Koshy George
President- Koshy & Associates Consulting, Inc

Koshy George has more than twenty years of experience in validation within the pharmaceutical and biopharmaceutical industries. Mr. George is currently President of Koshy and Associates Consulting Services Inc. He is working as a Quality Assurance Consultant for Cleaning Validation at Genzyme in Boston. Prior to this he was the Manager of Global Technical Services for Schering Plough and Merck. In this capacity, he was responsible for the cleaning validation programs at various sites around the world.

He has conducted training sessions for cleaning validation specialists. He has helped to find root cause to several persistent cleaning validation failures. He has worked with cleaning validation teams under Consent Decree in Wyeth, Schering-Plough, J & J-McNeill, and Sanofi-Genzyme. He has been an instructor of Cleaning Validation with IVT, IPA and PDA. He has served in the team that developed the PDA Technical Report #29 (Revised in 2012) “Points to Consider for Cleaning Validation”.

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