Using ICH Q9 and Recent FDA Comments as the Foundation for the Planning, Development and Execution of Risk-Based Cleaning Validation Studies

Instructor: John Hyde
Product ID: 701184
  • Duration: 90 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Feb-2009

Training CD / USB Drive

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(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

This Cleaning validation training will provide valuable assistance to all regulated companies that need to develop and validate their equipment cleaning processes.


This session will address risk-based approaches to cleaning validation studies using ICH Q9 and recent FDA comments and observations as a foundation. Recent FDA warning letters illustrate just how critical good cleaning practices are. Understanding and employing good cleaning practices are instrumental to improving cleaning consistency, quality and traceability. The FDA favors automated CIP systems since they reduce operator variability while enhancing consistency and reproducibility. Our research has indicated that in the last 5 years, cleaning citations were noted in 50% of warning FDA letters. Many cited contamination issues have an element of poor cleaning practices associated with them. Examples include “investigations…did not include an evaluation of the cleaning processes and procedures…to determine if equipment cleaning is effective in preventing cross contamination of the inactivated batches”, FDA Warning Letter, Jan 2008; "vaccine manufacturing plant in Pennsylvania, has been served with an FDA warning letter asking for measures to ensure batches of its flu shot ingredients do not become contaminated again.” Jul-2006..

An overview of ICH risk management techniques and how to apply them to equipment cleaning programs will be discussed. In addition, case studies from manufacturing facilities will be used to illustrate risk-based cleaning validation principles and practices.

Areas Covered in the seminar:

  • Review of industry current best practices and future trends for cleaning validation studies.
  • Review of ICH Q9 content with respect to cleaning validation.
  • Presentation of practical cleaning validation risk analyses and management tools.
  • Review of recent FDA comments and observations on risk-based validation.
  • Evaluation of the role of PAT in risk-based cleaning validation studies.
  • Review of Statistical Process Control (SPC) methodologies for ongoing monitoring of cleaning operations.

Who will benefit::

This webinar will provide valuable assistance to all regulated companies that need to develop and validate their equipment cleaning processes, including companies in the Biopharmaceutical, Pharmaceutical and Medical Device fields. The employees who will benefit include:

  • Quality Assurance professionals and mangers
  • Validation professionals, practitioners and mangers
  • Operations professionals and mangers
  • Engineering professionals and managers
  • Regulatory professionals

Instructor Profile:

John Hyde, is the Founder and Chairman of the Board for Hyde Engineering + Consulting, a firm of 80 professionals specializing in providing process systems design, commissioning, validation and FDA compliance services to biopharmaceutical and pharmaceutical manufacturers.

John has presented papers at numerous engineering conferences and short courses on topics including biopharmaceutical process systems design, cleaning and cleaning validation principles and practices, FDA compliance strategies, and control systems design for manufacturing processes. He has published ten articles on these subjects.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

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