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Contamination Control Strategy in a Light of Annex 1 Implementation

LIVE ONLINE TRAINING

4th - 5th December 2025

Who is Your 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 as Director of Global Pharmaceutical Technology at Shire Pharmaceuticals. He is currently holding a position of Principal Consultant at ValSource Inc. 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 participating 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.

Course Overview

Two-part course outlining all of the essential elements of effective and efficient, as well as compliant Contamination Control Strategy Program that is based on EMA Annex 1 requirements.

Objective

Provide participants with a comprehensive and all inclusive elements of Contamination Control Strategy, including examples and case studies.

Core Learning Outcomes

  • Understanding EMA Annex 1 and Its Impact on Contamination Control
  • Developing and Implementing an Effective Contamination Control Strategy (CCS)
  • Facility, Utility, and Equipment Design for Contamination Prevention
  • Environmental Monitoring, Qualification, and Recovery Planning
  • Personnel Training, Gowning, and Aseptic Behavior Standards
  • Raw Material, Product Container, and Closure Contamination Controls
  • Integrating CCS with Quality Systems and Risk Management

Registration Fee
€1198 + €35 Admin Fee

Registration

Registration Fee for Indian Audience
Rs 1,20,609 + Rs 3,523 Admin Fee

Registration
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