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.

1. Design Validation Protocol and Acceptance Criteria for Chromatographic
Methods to meet ICH requirements
December 09, Thursday 1:00 PM EST | 4:30 PM EST
Why Should You Attend:
Analytical procedures are used to assure that the drug product meets applicable standards of identity, strength, quality
and purity during its shelf-life. The majority of analytical methods used in pharmaceutical development are HPLC analy-
ses. cGMPs require validated stability indicating methods used to monitor the drug product’s stability profiles.
This interactive 4 hrs long course will examine validation parameters for HPLC methods used in pharmaceutical laborato-
ries based on cGMP regulations and ICH guidelines. It will discuss proved forced degradation strategies to develop
stability-indicating analytical procedures. Learn effective way to write validation protocol and determine acceptance crite-
ria for validation, make documentation more manageable. This course will provide a practical and systematic approach to
validate analytical procedures.
Date: December 09, Thursday 2010
Time: 1:00 PM EST | 4:30 PM EST
Duration: 04 hrs
Instructor: Kim Huynh-Ba
Location: Your office or conference room (no need to travel!)
Areas Covered in the Seminar:
• Module I. Regulatory Requirements for Analytical Test Methods ( 40 mins)
o Drug Development Process
o cGMP requirements for analytical test methods
o Review ICH Q2 A&B guidelines for method development/validation
• Module II Development and Validation Stability Indicating Methods ( 35 mins)
o Design method specificity through forced degradation activities
o Discuss validation characteristics
• Module III. Designing Method Validation Protocols ( 35 mins)
o Establish Method Validation Protocol
o Establish Method Validation Protocol
• Module IV. Managing Validation Data for Quality and Compliance ( 55 mins)
o Design Phase-appropriate method validation
o Handling validation failure
Kim Huynh-Ba
Register Now

2. 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 Re-
searchers 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 develop-
ment experience.
Instructor Profile:
Kim Huynh-Ba, is the founder and Technical Director of Pharmalytik (www.pharmalytik.com). She has twenty
two years of experience in various analytical areas of pharmaceutical development and a primary focus in
stability sciences. Prior to Pharmalytik, she held positions in drug development at Astra Zeneca (formerly ICI
Americas), DuPont Merck, DuPont Pharmaceuticals, Bristol Myers Squibb and Wyeth Vaccines. She has
been advising pharmaceutical companies including companies operating under Consent Decree on harmo-
nization and optimization of analytical best practices since 2001.
Registration Information:
* Register Online. Use your American Express, Visa or MasterCard.
* For more than one attendee get 20% off on the price of additional attendee.
* Get your group to attend the webinar at a discounted price call +1- 650-620-3937.
* Call +1 - 650-620-3937 or Fax your PO: 650-963-2556.
* Mail your check to: ComplianceOnline (MetricStream, Inc), 2600 E. Bayshore Road, Palo Alto, CA 94303.
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