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Cleaning Validation Guidelines - Webinar

  • ID: 3946372
  • Webinar
  • August 2017
  • Region: Global
  • 90 Minutes
  • Online Compliance Panel
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This webinar discusses global Cleaning Validation Guidelines 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. Additionally, recommendations on compliant and sustainable program will also be covered, as well as regulator's expectation for these programs.

Objectives of the Presentation:
  • Cleaning Process
  • Cleaning Verification
  • Cleaning Validation
  • Risk Management
  • Knowledge Management
  • Qualification of CIP Equipment
  • Health Based Cleaning Validation Limits
  • 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 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.

Areas Covered:
  • Cleaning Validation Guidance
  • Establishing Health Based Limits
  • Quality Risk Management
  • Lifecycle Approach
  • Cleaning Verification
  • Continued Validation Monitoring
  • Cleaning Analytical and Microbial Methods
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  • Igor Gorsky Igor Gorsky,

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  • Validation
  • Quality Assurance
  • R & D
  • Production
  • Quality Control
  • Microbiology
  • Engineering
  • 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
Note: Product cover images may vary from those shown