ComplianceOnline

Reducing Cleaning Validation Costs Using ICH Q9 and Recent FDA Guidance

Instructor: John Hyde
Product ID: 701437
  • Duration: 60 Min

recorded version

$299.00
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: Sep-2009

Training CD / USB Drive

$500.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This Cleaning Validation training /webinar will discuss the risk based approach to cleaning validation with reference to ICH Q9.

This session will address risk-based approaches to cleaning validation studies that reduce costs by using ICH Q9 and recent FDA comments and observations as a foundation. Case studies from manufacturing facilities will be used to illustrate risk-based cleaning validation principles and practices.

Areas Covered in the seminar:

  • 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.
  • Case studies - manufacturing facilities.

Who will benefit:

  • 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.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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