LYOPHILIZATION TECHNOLOGY
PROCESS VALIDATION-LIFECYCLE APPROACH
26th - 27th November
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
During this 2-part session, we will discuss the development of lyophilization validation guidance, design and development of pharmaceutical lyophilization processes, use of quality risk management and knowledge management in the development of lyophilization pharmaceutical processes, development of control strategy, process performance qualification.
We will also touch upon the use of statistics in lyophilization validation process and talk about continued process verification. We will concentrate on a risk based approach as it is a corner stone of process validation principals and practice.
If you are a professional who is involved in the development of pharmaceutical and biopharmaceutical products and processes using lyophilization, qualification of the lyophilization equipment, utilities used for lyophilization and processes, trending and monitoring of performance of lyophilization pharmaceutical processes throughout the continuous lifecycle this course is definitely for you.
Key Learning Objectives
- Understanding Lyophilization Process Validation Guidance
- Learn principals of Quality by Design
- Understand how risk assessment helps develop process control strategy
- Learn how to design Process Performance Qualification Study
- Understand how to use statistical principles in design of PPQ
- Understand basis for Continued Verification Program