The webinar will address aspects of development and manufacture of the drug substance including steps to reduce impurities. By the end of this program, attendees will understand the requirements of the ICH Q11 guidance and learn skills for practical implementation of those requirements.
It will be an important educational event which helps in understanding of ICH Q11 in a light of regulators' guidance to risk based lifecycle approach to drug substance development.
Learning Objectives:
- Understand the basic concepts found in ICH Q11
- Understand use of QbD in API manufacturing process development
- Understand how the ICH Q11 supports the lifecycle concepts
- Understand the interdependence of the Q-8-Q11 set of guidance's
- Understand how the life cycle concepts apply to the process design
- Be able to develop a systematic approach to API process development that is found in ICH Q11
Why Should You Attend:
ICH Q11 provides approaches to developing and understanding the manufacturing process development of APIs, and also provides a direction for drug-substance manufacturers to follow while preparing their regulatory submissions based on QbD.
There are requirements to describe, in sufficient detail, the choice of starting materials, design and development of the manufacturing processes using DoE's, process control strategies, critical quality attributes and critical process parameters as well as approaches towards continuous improvements and continued monitoring.
This webinar will address approaches to developing and understanding the manufacturing process for a drug substance.
Topics
- QbD
- DoE
- Manufacturing process development
- Process controls
- Selection of starting materials
- Control strategy
- Process validation evaluation
- Submission of information
- Life cycle management
Instructor
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 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.