Design Validation Protocol and Acceptance Criteria for Chromatographic Methods to meet ICH requirements

NOTE: Use This Promocode ( 117660 ) To Get 10% Discount. 

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 analyses. 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 laboratories 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 criteria for validation, make documentation more manageable. This course will provide a practical and 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

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 harmonization and optimization of analytical best practices since 2001.

In addition to her consulting activities, Kim is a short course instructor and organizer on topics ranging from cGMP compliance and quality issues to stability programs under sponsorship of global organizations such as American Chemical Society (ACS), American Association of Pharmaceutical Scientists (AAPS), Pittsburgh Conference, many other international training groups. Kim is a Visiting Professor at Rowan University and serves on the Governing Board of Eastern Analytical Symposium (EAS). She is the founder and past co-chair of the AAPS Stability Focus Group, and an active member of the Pharmaceutical Stability Discussion Group (PSDG). She currently is Chair of the AAPS APQ e-Learning Committee and the 2008 EAS Short Course Program. She is a member of USP’s Prescription/Non-Prescription Stakeholder Forum, USP Reference Standard Project Team and CHPA Impurities Working Group. Kim is a recipient of the 2008 AAPS APQ Service Award and 2008 Recognition Award of AAPS Regulatory Section. She also received the 2001 DPCAA Leadership Award.