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34594 Conferences

Design Validation Protocol and Acceptance Criteria for Chromatographic Methods to meet ICH requirements - Webinar By ComplianceOnline

Added by Referral on 2010-10-21

Conference Dates:

Start Date Start Date: 2011-01-28

Conference Contact Info:

Contact Person Contact Person: admin
Email Email:
Address Address: 2600 E. Bayshore Road, Online Event, CA, 94303, United States
Phone Tel: 650-620-3915
Phone Fax: 650-963-2556

Conference Description:

This Design validation 4 hour session will discuss how to write validation protocol and determine acceptance criteria. It will also explain the systematic approach to validate analytical procedures.

Areas Covered in the Seminar:

Module I. Regulatory Requirements for Analytical Test Methods ( 40 mins)
Drug Development Process
cGMP requirements for analytical test methods
Review ICH Q2 A&B guidelines for method development/validation
Module II Development and Validation Stability Indicating Methods ( 35 mins)
Design method specificity through forced degradation activities
Discuss validation characteristics
Module III. Designing Method Validation Protocols ( 35 mins)
Establish Method Validation Protocol
Establish Method Validation Protocol
Module IV. Managing Validation Data for Quality and Compliance ( 55 mins)
Design Phase-appropriate method validation
Handling validation failure

Time Schedule:

Duration : 3.5 hours of instruction, 15 min breaks as they fit into the schedule

(All times in Eastern Standard Time)

1:00 PM EST - 1:40 PM EST - Module 1
1:40 PM EST -- 2:15 PM EST - Module 2
2:15 PM EST -- 2:30 PM EST Q/A of Module 1&2
2:30 PM EST - 2:45 PM EST - Break
2:45 PM EST - 3:20 PM EST - Module 3
3:20 PM EST - 4:15 PM EST - Module 4
4:15 PM EST 4:30 PM EST Q/A of Module 3&4

Who Will Benefit:

This course will benefit R&D analysts, QA and QC Managers, Regulatory scientists, Directors, Regulators and Researchers who are responsible for providing analytical data pertaining to pharmaceutical products. To get the most out of the course, we highly recommended that you have at least two years of pharmaceutical analysis or drug development experience.

Note: Use these promocode(117660) for 10% discount.
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