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Common Deficiencies in Method Validation of Analytical Procedures - for Pharmaceutical Scientists

 
  September 12, 2012  
     
 
ComplianceOnline, Online Event
2012-09-20


Why Should You Attend:

New medicines are developed every day to meet medical needs and improve quality of life. Analytical procedures are used to establish acceptance criteria and monitor quality of drug products. Therefore, validation becomes a critical process especially with the changes throughout the drug development process. It is important to understand validation requirements set forth by ICH and FDA.

This 90-minute webinar will present the common deficiencies in relation to method validation, outline regulatory requirements and the change control process needed to stay in compliance.

Learning Objectives:

Upon completion of this session, attendees will learn key factors that would affect validation process of analytical procedures. One must understand validation characteristics and able to determine when re-validation would need to take place.

Areas Covered in the Seminar:

  • Deficiencies related to Method Validation.
  • Factors affecting Quality of Medicines.
  • Validation Characteristics.
  • Validation vs. Re-Validation plan.
  • Tracking record of validation project.
  • Change control of validation.
Event Details:
 
Date:                     September 20, 2012
Time:                    10:00 AM-11:30 AM PDT
Cost:                     $249 per attendee per computer terminal
Registration:         SIgn-Up on-line now.  Add to your shopping cart.
 
 
Organized by: ComplianceOnline
Invited Speakers: Kim Huynh-Ba, has almost 25 years of experience in analytical development, project management, strategic drug development and stability sciences. She is the Executive Director of Pharmalytik, where she provides consulting and training services to pharmaceutical companies including companies operating under FDA’s Consent Decree on harmonization and optimization of analytical best practices. Prior to this position, she was the Director of Pharmacopeial Education Department of U.S. Pharmacopeia (USP), where she was responsible for their education programs worldwide.
 
Deadline for Abstracts: 2012-09-20
 
Registration: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702386?channel=hummolgen
E-mail: referral@complianceonline.com
 
   
 
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