A Life Cycle Approach to Ensure Compliance, Efficiency and Effectiveness

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4th Annual Cleaning Validation Workshop 2019

Cleaning Validation is documented evidence with a high degree of assurance that one can consistently clean a system or a piece of equipment to predetermined and acceptable limits. The prime purpose of validating a cleaning process is to ensure compliance with federal and other standard regulations.

Today, most of the drug manufacturing companies are facing issues in setting up acceptance limits, deciding on choosing analytical methods and implementing effective sampling techniques.

This workshop will discuss about Cleaning Validation guidelines, practices and innovations that include development of cleaning process programs and cleaning verification and validation programs. The Workshop Trainer will discuss regulatory validation guidelines and show how quality risk management should be utilized in implementation of risk-based lifecycle approach to cleaning validation.

During this 2-day workshop, the trainer will also touch upon use of statistics in the process of cleaning validation and talk about continued verification/monitoring. The focus would be on a risk-based approach as it is a corner stone of cleaning process validation principals and practice. This will be an interactive workshop.

About the Workshop Trainer

Igor Gorsky

Igor Gorsky has been a pharmaceutical industry professional for over 30 years. He held multiple positions with increasing responsibility at Alpharma, Wyeth and Shire. He worked in Production, Quality Assurance, Technical Services and Validation including an Associate Director of Global Pharmaceutical Technology at Shire Pharmaceuticals.

He is currently holding a position of Senior Consultant at ConcordiaValsource, LLC. His over the years accomplishments include validation of all of the aspects of pharmaceutical and biotechnology production and quality management, technical support of multi-billion dollar drug product lines and introduction of new products onto the market.

He had published articles and white papers in pharmaceutical professional magazines and textbooks. In addition, he had been a presenter at Interphex. He is also very active with PDA leading in several Task force groups authoring PDA Technical Reports 29 (Points to Consider for Cleaning Validation) and 60 (Process Validation). He is leading PDA Water Interest Group. He holds a BS degree in Mechanical and Electrical Engineering Technology from Rochester Institute of Technology.

USP of the workshop

Trainer with 30+ years of "hands-on" Validation experience

Interactive case studies & group exercises

Content covering all the aspects of cleaning validation process and techniques

Dedicated Q&A sessions

12+ hours of learning


Key topics to be discussed

Current Regulatory Environment and Expectations
Newest Developments - ASTM E3106 and three stage approach
Risk Assessment for Cleaning and Cleaning Validation
Calculation of Cleaning Validation limits using Health Based Exposure Limits (ADE/PDE)
How to determine Worst Case soil with New Science and Risk Based Approach
Lifecycle Approach to Validation - Three Stage Approach
Different Sampling techniques and Analytical Methods for Cleaning
How to Maintain Validated State

Who should attend

Directors / Associate Directors / VPs / AVPs / Plant Heads / Site Heads / Managers / Senior Managers / Assistant Managers/ General Managers / Executives from:

Quality Assurance Quality Control R&D Manufacturing/Production Validation

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