Process Validation – Lifecycle Approach

Duration: 60-75 minutes

Level: Advanced Professional

Date: 31st January 11.30 AM EST.

Why Should You Attend?

If you are a professional involved in the development of pharmaceutical and biopharmaceutical products and processes, qualification of equipment, facilities, utilities and processes, and monitoring the performance of pharmaceutical lifecycle processes, this webinar is definitely for you.

During this session we will discuss about revised validation guidance, design and development of pharmaceutical processes, and the use of quality risk management and knowledge management in the development of pharmaceutical processes, control strategies, and process performance qualification. We will also touch upon the use of statistics in validation processes and continued process verification. We will concentrate on a risk-based approach as this is the corner stone of process validation principles and practices.

Areas Covered in the Webinar:

  • Risk Based Approach
  • Quality by Design
  • Critical Quality Attributes
  • Critical Process Parameters
  • Process Control Strategy
  • Statistical Sampling
  • Process Performance Qualification
  • Continued Process Verification Programs

Key Learning Objectives:

  • Understand about Process Validation Guidance
  • Learn the principals of “Quality by Design”
  • Understand how risk assessment helps in developing a process control strategy
  • Learn how to design Process Performance Qualification (PPQ) Study
  • Understand how to use statistical principles in designing PPQ
  • Understand the basis for Continued Process Verification Program (CPV)

Who will benefit?

All levels of management across the following disciplines:

  • Quality Assurance/ Quality Control (Chemistry and Micro)
  • Product and Process Development
  • Validation
  • Manufacturing Operations
  • Engineering
  • Regulatory Affairs

Instructor Bio:

Mr.Igor Gorsky has been a pharmaceutical, biopharmaceutical, and medical device 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 Head of Validation of Global Pharmaceutical Technology at Shire Pharmaceuticals. Igor currently holds a position as Senior Consultant at ConcordiaValsource, LLC. His accomplishments include validation of all aspects of pharmaceutical and biotechnology production and quality management, technical support for multi-billion-dollar drug product lines, and the introduction of new and innovative products into the market. Igor has published articles and white papers in pharmaceutical professional magazines and textbooks. He was also a presenter at Interphex, AASP and other forums. Igor is very active with PDA, participating in several Task Force groups and authoring PDA Technical Reports 29 (Cleaning Validation) and 60 (Process Validation). He is leading the PDA Water Interest Group. Igor holds a BS degree in Mechanical and Electrical Engineering Technology from Rochester Institute of Technology.

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