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.
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.
Worshop explained about criticality of cleaning validation and maco valuesM.Sivaprakashreddy
Caplinpoint Laboratories Limited
It helped to understand how to incorporate the current trends in cleaning validation processK Sujata
Gland Pharma Limited
Two days workshop was detailed on the methodologies and the best practices required for CVVishal Kamde
It helped to design and improve current approach of cleaning validationAlpesh Chaudhary
I found it useful with respect to TOC analysis subject & ADE conceptDhananjay Alange
Got to know many approach for cleaning validation based on numerous challenges of different products and formulationsKavita
Group Leader Roc at Validation
Got insight on regulatory requirements and different formulations approachAruna Vijay Palnitkar
Sanofi India Limited
I could understand that importance and impact of cleaning of equipment and process materials on the product quality and safetyM Selvakumar