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Réf : 21757
Evènement :Lifecycle Approach to Analytical Methods for Drug Products: Incorporating QbD Concepts into Method Development, Validation, Verification and Transfer

Dates :Jeudi 12 Octobre 2017 - Vendredi 13 Octobre 2017

Lieu :TBA - Philadelphia
Philadelphia, Pennsylvania, États-Unis

Type :Conférence & Séminaire - Audience Internationale

Accréditation :--


 

Informations

Top 5 Reasons to Attend this Seminar:

  1. Learn how to use a Lifecycle Approach to apply QbD concepts to Analytical Methods
  2. Learn how the Analytical Target Profile can drive the Lifecycle Approach
  3. Discover how a lifecycle approach can link method development, validation, verification and transfer and continued method use
  4. Learn about the importance of linking method uncertainty to specifications
  5. Using a method feedback loop to facilitate method improvement

This highly interactive course is designed to provide participants with a lifecycle approach to developing and validating analytical methods, including elements aligned with QbD concepts. The course starts by introducing the Lifecycle Approach and discussing some of the key terms. By using the lifecycle approach, methods are more likely to meet their intended purpose, and scientists are more likely to have success during validation and transfer exercises. The course will build on traditional concepts of method development, validation and transfer by introducing the Analytical Target Profile (which identifies what the method is expected to accomplish), fostering method understanding (using QbD concepts to explore the method operable region and stressing the importance of real samples in the environment where they will be tested) and demonstrating how these principles can be used iteratively as methods change location or evolve technically. This approach will be linked with current compendial requirements. There will be an opportunity for questions and interaction throughout the course.

 

Learning Objectives:

  • Understand the lifecycle approach to method development and validation.
  • Understand the different types of methods required for different types of drug products, and the various types of impurities which must be addressed
  • Identify an Analytical Target Profile for Methods Being Developed
  • Use an IQ/OQ/PQ Approach to Method Qualification
  • Develop Appropriate Protocols for Method Transfer
  • Comply with Compendial Requirements with Greater Success and Fewer Resources
  •  

  • Who will Benefit:

    Chemists, supervisors, managers or directors from pharmaceutical (human and veterinary), generic or OTC companies or contract research organizations who are responsible for development, validation, verification or transfer of analytical methods, and regulatory affairs/CMC personnel responsible for filings involving analytical methods.

 

For Registrationhttp://www.complianceonline.com/applying-qbd-concepts-to-method-development-validation-verification-transfer-of-drug-products-seminar-training-80236SEM-prdsm?channel=doctorama

 

Note: Use coupon code  NB5SQH8N  and get 10% off on registration.

 

Lieu

Plan et itinéraire
Adresse de la conférence :
TBA - Philadelphia
Philadelphia
Pennsylvania, États-Unis
Plan et itinéraire

Renseignements

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Précisions

Lifecycle Approach to Analytical Methods for Drug Products: Incorporating QbD Concepts into Method Development, Validation, Verification and Transfer Pharmacie
qbd, quality by design, analytical target profile, atp, compendial requirements
Professionnels, Chemists (Research, Quality Control, CRO) Regulatory Affairs/CMC Personnel Laboratory Managers and Staff Analysts QA/QC Managers and Personnel
40 1 --
English

Divers

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