Insights into NEW ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, and Controls Webinar

Complimentary
Learning Level: Basic/Intermediate/Advanced

This Webinar summarizes the recently published ISPE Guide on Cleaning Validation. It will present the guide topics, key principles and current approaches for the implementation of compliant cleaning programs. 

Learning Objectives : 

  1. Understand the new ISPE Guide scope, content, and applicability. 
  2. Review a summary of the guide content; chapter by chapter. 
  3. Identify approaches to establish cleaning programs that meet or exceed regulatory expectations.

Cleaning Validation Lifecycle – Applications, Methods, and Controls

This ISPE Guide: Cleaning Validation Lifecycle - Applications, Methods, and Controls provides a hands-on approach to support the life science industry in the development and establishment of compliant cleaning programs that meet or exceed regulatory expectations. Topics covered include:

  • Application of risk management
  • Adoption of a lifecycle approach for cleaning validation
  • Cleaning methodologies
  • Creation of cleaning validation acceptance criteria
  • Determination of visual inspection limits
  • Calculation and justification of residue limits
  • Validation of testing and sampling methods
  • Equipment issues and challenges
  • Change Management

Register


Speakers

Jose A. Caraballo
Head Audit Program Management Americas, Corporate Quality Audit and Inspections
Bayer US
Co-lead
Joseph Payne
VP, Quality & Regulatory
Tergus
Co-lead
Catherine T. Oakes
Managing Director
Oakes Group Global Ltd.
Fred Ohsiek
Senior Specialist
Novo Nordisk Pharmaceuticals Industries, Inc
David W. Vincent
CEO
VTI Life Sciences, Inc.
Beth A. Kroeger-Fahnestock
Technical Services Senior Manager
Steris Corp.

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