Risk Assessment in Cleaning Validation

Duration: 90 Minutes
This webinar discusses the use of risk management in global guidance, such as ICH Q9 as they are currently available for pharmaceutical and biopharmaceutical industries. In addition, it describes use of QRM (quality risk management) in Cleaning Validation and growing trend of applying this approach to lifecycle of product manufacturing process. Establishing of health based Cleaning Validation limits also discussed in this session, as it is recommendation of ICH Q9. Additionally, recommendations on compliant and sustainable program will also be covered, as well as regulator's expectation for these programs.
Quality Risk Management in Cleaning Validation
Instructor: Igor Gorsky
Product ID: 503911
Objectives of the Presentation
  • Quality Risk Management
  • Cleaning Process
  • Cleaning Verification
  • Cleaning Validation Guidance
  • Knowledge Management
  • Establishing Health Based Cleaning Validation Limits
  • ADE/PDE
  • Critical Process Parameters
  • Critical Quality Attributes
  • Control Strategy
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 webinar is definitely for you. During this session we will discuss use of quality risk management that used in 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.

Areas Covered
  • Lifecycle Approach
  • Continued Validation Monitoring
  • Cleaning Analytical and Microbial Method
Who will Benefit
  • Technical Services
  • Validation
  • Quality Assurance
  • R & D
  • Operations/Production
  • Quality Control
  • Microbiology
  • Engineering
  • Production
  • Senior quality managers
  • Quality professionals
  • Production supervisors
  • Validation engineers
  • Process owners
  • Quality engineers
  • Quality auditors
  • Analytical method development personnel
  • Quality control and quality assurance personnel
  • Pharmaceutical and biopharmaceutical industries
Topic Background
Implementation of Quality Risk Management is regulatory requirement. Cleaning Validation is also a regulatory requirement as well as expectation. In addition robust and compliant cleaning validation program makes perfect business sense for successful manufacturing facilities. Use of QRM in developing of successful Cleaning processes and Cleaning Validation program provides tremendous help to practitioners.
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Instructor Profile:
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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