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Cleaning Validation Roadmap

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February 27, 2019 @ 8:30 AM - 4:30 PM

San Diego, United States

COURSE DESCRIPTION:

An effective cleaning validation program is essential for a successful regulatory inspection. Over the years, it is a challenge for the industry to develop effective cleaning validation program that meets regulatory expectations. A cleaning validation program includes strategies for procedure development, product families, contact equipment, analytical methods, sampling and acceptance criteria. This seminar provides a roadmap to apply FDA’s Process Validation Life Cycle guidance and ICH Q9 Quality Risk core principles for cleaning validation program. This seminar also shows you how to develop safer, compliant and efficient cleaning validation program.

 

Top 10 Reasons to Attend:

  1. Know FDA 483s statistics specific and the top 5 observations
  2. Select analytical test method and understand validation methodology
  3. Apply ICHQ9 Quality Risk Management core principles for cleaning validation
  4. Master FDA’s Process Validation Guidance and a 3-stage approach
  5. Design cleaning process design and develop requirements – Stage 1
  6. Perform a cleaning Process Performance Qualification (PPQ) – Stage 2
  7. Set effective risk-based Continued Process Verification (CPV) program – Stage 3
  8. Understand documentation requirements for validation
  9. Set health-based limit and safety of margin
  10. Know global cleaning validation regulatory requirements (EU, FDA, Health Canada)

 

Personnel in the Following Environments Should Attend:

  • Validation
  • QA/QC
  • Engineering
  • Regulatory Affairs
  • Compliance
  • Manufacturing
  • Laboratory

 

***Attend this event along with Advanced Cleaning Validation & Critical Cleaning Processes and save $200.00!  Select the dual event ticket type for $1790.00 to register for both seminars and save!***

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Venue

Details

Date:
February 27, 2019
Time:
8:30 AM - 4:30 PM
Event Category:

Venue

San Diego, CA
San Diego, CA 92109 United States + Google Map

Pricing & Registration

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