Date

May 19, 2020

Duration

4 Hours

Time

11 AM EDT/8 AM PDT/8:30 PM IST

Level

Advanced Professional

Why Should You Attend?

If you are a professional who is involved in a development of pharmaceutical and biopharmaceutical products and processes’ cleaning procedures throughout the continuous lifecycle of drug products this virtual workshop is definitely for you. During this session we will discuss Cleaning Validation Guidelines that include 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 implementation of risk-based lifecycle approach to cleaning validation. We will also touch upon a use of statistics in cleaning validation process and talk about continued verification/monitoring. We will concentrate on a risk-based approach as it is a corner stone of cleaning process validation principals and practice. Some of the main concepts of 21-st Century Cleaning Validation programs will be disc used including Health Based Limits and Data Analysis.

Areas Covered in the Virtual Workshop:

Part 2 – 19th May 2020

  • Statistical Analysis of “Censored Data” of cleaning validation
  • Design of Operator friendly and regulatory compliant Cleaning
  • Methods Used for Sampling and Analytical and New Microbial Rapid
  • Validation of Multi-Product Facility

Key Learning Objectives of your Topic:

  • Cleaning Validation Guidance
  • Establishing Health Based Limits
  • Quality Risk Management
  • Lifecycle Approach
  • Cleaning Verification
  • Continued Validation Monitoring
  • Cleaning Analytical and Microbial Methods

Who will be benefited?

This virtual workshop is targeted toward the following organizational positions and disciplines. It will be discussed in a pragmatic and practical understandable language by all technically educated or trained professional. This information would be useful at levels from senior management to those who is involved in product development, manufacturing, and testing. It would be valuable for experience levels ranging from seasoned veterans to those newly assigned to roles process validation:

  • Validation
  • Quality Assurance
  • R & D
  • Production
  • Quality Control
  • Microbiology
  • Engineering

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 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.

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