Date

April 22, 2021

Duration

60-75 minutes

Time

10:00 AM PST/1:00 PM EST

Level

Advanced Professional

Why should you attend?

If you are a professional who is involved in the planning, design, purchase, qualification, validation, and continuous lifecycle management of facilities and equipment, this webinar is for you. In this session we demystify the lifecycle risk-based approach to qualification of facilities and equipment, which is vital to successful process validation of pharmaceutical/ biopharmaceutical products, as well as to sustainable and reproducible manufacturing activity. We will review case studies from recent regulatory observations, which will help you learn from other companies’ shortcomings. Finally, we discuss why digitization as a preferable and sustainable approach to lifecycle management is necessary.

Areas covered:

  • Risk Based Approach
  • Design of Facilities and Equipment
  • Installation Qualification Concept
  • Operation Qualification – What is Involved
  • Performance Qualification for Equipment and Facilities
  • Sampling Schemes
  • Data Analysis
  • Continued Verification

Key learning objectives:

  • Dispel mistaken paradigms regarding the risk-based approach to the Qualification of Facilities and Equipment lifecycle.
  • Understand how to eliminate variability – the cause of most deviations.
  • Understand how to best design facilities and equipment that would support manufacturing that will continually meet product and process requirements.
  • Capitalize on the advantages of on-line analytical instrumentation (temperature, relative humidity, and even microbiological rapid methods).

Who will benefit?

The information shared in this webinar will benefit all levels – from senior management to those who are involved in the operation of Facilities and Equipment on a day-to-day basis. This webinar is particularly targeted at the following organizational positions and disciplines.

  • Quality Assurance/ Quality Control (Chemistry and Micro)
  • Process and Design Engineering
  • Process Automation
  • Manufacturing Operations
  • Validation
  • Utility Operations
  • Regulatory Affairs

Instructor Bio

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 an Associate Director of Global Pharmaceutical Technology at Shire Pharmaceuticals. He currently holds the position of Senior Consultant at ConcordiaValsource, LLC. His accomplishments over the years include validation of all aspects of pharmaceutical and biotechnology production and quality management, technical support of multi-billion-dollar drug product lines, and introduction of new products into the market. Igor has published articles and white papers in pharmaceutical professional magazines and textbooks. In addition, he has been a presenter at Interphex. He is also very active with PDA, participating in several Task force groups and authoring PDA Technical Reports 29 (Points to Consider for Cleaning Validation) and 60 (Process Validation). He leads the PDA Water Interest Group.  Igor holds a BS degree in Mechanical and Electrical Engineering Technology from Rochester Institute of Technology. In addition, Igor has conducted extensive auditing and lead training programs for pharmaceutical and biopharmaceutical practitioners abroad (China, India, Israel and other countries).

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