Validation, Verification and Transfer of Analytical Methods 2017

  • 1695.00 Dollar US$
  • Published date: January 10, 2017
    • Zurich, Switzerland, United States

Overview:
Analytical methods and procedures should be validated to ensure reliability, consistency and accuracy of analytical data. Compendial methods should be verified to demonstrate the suitability of laboratories to successfully run the method and when methods are transferred between laboratories successful transfer should be demonstrated through testing. In case a laboratory wants to use an alternative method instead of a compendial method, equivalency of the alternative method to the compendial method should be demonstrated.
Who will benefit:
• QA Managers and Personnel
• Quality Control
• Method Development
• Analytical Chemists
• Validation Specialists
• Laboratory Managers and Supervisors
• Regulatory Affairs
• Training Departments
• Documentation Departments
• Consultants
Agenda:
Day 1 Schedule
Lectures and Workshop Exercises
Lecture 1:
Regulatory Background and Requirements
• FDA and international requirements
• The importance of ICH Q2 and USP chapters
• USP approach for method validation: New/revised Chapters 220, 1200, 1210, 1220, 1225
• Learnings from the NEW FDA and WHO method validation guidelines
• Different requirements for GLP, GCP and GMP
• The importance and steps of risk assessment
• Exercise: Define risk numbers for different methods
• Lessons from recent FDA Warning Letters
• Planning for cost-effective implementation
Lecture 2:
Preparing Your Lab for Validation Studies
• Analytical Instrument qualification
• Part 11/Annex 11 compliance of computer systems
• Validation of chromatographic data systems
• Validation and control of Excel spreadsheets
• Qualification of reference standards and materials
Lecture 3:
Validation of Analytical Methods and Procedures
• Developing a validation plan and SOP
• ICH Q2 validation and test parameters:
Accuracy, precision, intermediate precision, specificity, LOD, LOQ, linearity, range, robustness, ruggedness
• Examples for application specific acceptance criteria
• Examples for design and execution of test experiments
• Evaluation of test results: using statistical models
• Handling deviations from expected test results
• Going through an example validation report
Lecture 4:
Verification of Compendial Methods
• FDA and equivalent international expectations
• Scope and objectives of USP <1226>
• USP <1226> verification requirements
• Risk based approach for type and extent of verification testing
• Which validation parameters should be verified
• Logical process to set acceptance criteria
• Exercise: Application based verification testing


Location: Zurich, Switzerland Date: March 20th & 21st, 2017 and Time: 9:00 AM to 6:00 PM

Venue: Hilton Zurich Airport
Address: Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland. +41 44 828 50 50

Price:

Price: $1,695.00 (Seminar Fee for One Delegate)

Until February 10, Early Bird Price: $1,695.00 from February 11 to March 18, Regular Price: $1,895.00

Register for 5 attendees Price: $5,085.00 $8,475.00 You Save: $3,390.00 (40%)*

Quick Contact:
NetZealous DBA as GlobalCompliancePanel

Phone: 1-800-447-9407
Fax: 302-288-6884
Email: support@globalcompliancepanel.com
Website: http://www.globalcompliancepanel.com
Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900858SEMINAR?channel=mailer&camp=Seminar&AdGroup=science-marketplace_March_2017_SEO

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