Igor Gorsky has been a pharmaceutical industry professional for over 30 years. He held multiple positions with increasing responsibility at Alpharma, Wyeth, and the 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 as Senior Consultant at ConcordiaValsource, LLC. His over the year’s 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 Taskforce groups authoring PDA Technical Reports 29 (Points to Consider for Cleaning Validation) and 60 (Process Validation). He is leading the PDA Water Interest Group. He holds a BS degree in Mechanical and Electrical Engineering Technology from Rochester Institute of Technology.
This webinar discusses global Cleaning Validation as it is implemented in the pharmaceutical and biopharmaceutical industries. In addition, it describes the use of QRM (quality risk management) in Cleaning Validation and the growing trend of applying this approach to the lifecycle of the product manufacturing process. Establishing health-based Cleaning Validation limits also discussed in this session. Additionally, recommendations on the compliant and sustainable programs will also be covered, as well as the regulator’s expectations for these programs.
Cleaning Validation is a regulatory requirement as well as expectations. In addition, a robust and compliant cleaning validation program makes perfect business sense for successful manufacturing facilities.
- Cleaning Validation Guidance
- Establishing Health-Based Limits
- Quality Risk Management
- Lifecycle Approach
- Cleaning Verification
- Continued Validation Monitoring
- Cleaning Analytical and Microbial Methods
Course Level - Advanced
Who Should Attend
- Medical Devices
- Quality Assurance
- R & D
- Quality Control
Why Should You Attend
If you are a professional who is involved in the development of pharmaceutical and biopharmaceutical products and processes’ cleaning procedures throughout the continuous lifecycle of drug products this webinar is definitely for you. During this session, we will discuss Cleaning Validation that includes the development of cleaning process programs and cleaning verification and validation programs. We will discuss regulatory validation guidance and show how quality risk management should be utilized in the implementation of a risk-based lifecycle approach to cleaning validation. We will also touch upon the use of statistics in the cleaning validation process and talk about continued verification/monitoring. We will concentrate on a risk-based approach as it is a cornerstone of cleaning process validation principles and practice.