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Why and How - Verification of Compendial Methods - USP <1226>

ComplianceOnline

Tuesday, February 12, 2013 from 10:00 AM to 11:30 AM (PST)

Palo Alto, CA

Why and How - Verification of Compendial Methods - USP

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Ticket Type Sales End Price Fee Quantity
Online Registration Ended $299.00 $17.44

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Event Details

This USP <1226> webinar training will discuss the requirements of USP <1226>, what are FDA expectations related to method verification.

Why Should You Attend:

Analytics continues to be a challenging area for GMP compliance and the number of warning letters that are focused on this area continue to increase . Non-compliance to USP <1226> feature prominently in the 483s issued. Laboratory staff continues to have questions about the difference between method Validation and Verification and the conditions under which these two different concepts need to be applied.

This webinar will provide an in-depth discussion of USP <1226>, 'Verification of Compendial Methods' requirements. FDA 483s on the subject of Method Verification will be discussed to understand current FDA expectations. Conditions under which Methods can be classified as 'basic' and not require verification will be discussed. The factors under actual conditions of use which impact method performance and make method verification necessary will be addressed. FDA 483s on the subject of Method Verification will be discussed to understand current FDA expectations on which compendial methods needs to be verified.

Areas Covered in the Seminar:

  • FDA 483s related to method verification.
  • Requirements of USP <1226>, 'Verification of Compendial Methods'.
  • What are the current FDA expectations related to method verification.
  • FDA 483s related to method verification.
  • Requirements of USP <1226>, 'Verification of Compendial Methods'.
  • What are the factors which impact method performance under actual condition of use?
  • How compliance to USP <1226> and investment risk.

 

For Registration:

When & Where



Online Webinar
2600 E. Bayshore Road
Palo Alto, CA 94303

Tuesday, February 12, 2013 from 10:00 AM to 11:30 AM (PST)


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Organizer

ComplianceOnline

At ComplianceOnline, we are focused on :

 

  • Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
  • Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
  • Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
  • Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.

 

 

 

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