A Risk Based Strategy for the Development & Validation (NTZ)

A Risk Based Strategy for the Development & Validation (NTZ)
At
The DoubleTree Baltimore-BWI Airport
For more information: https://www.eventbrite.com/e/a-risk-based-strategy-for-the-development-validation-ntz-tickets-42944031755?aff=RMV

DESCRIPTION
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A Risk Based Strategy for the Development & Validation of and Validation of Analytical Methods with a QbD Approach

Following the initial development, the steps further continues thru optimization and subsequently to Validation, leading to the understanding of Validation Parameters and their generic definitions. Guidance from EP, USP, ICH Q2 (R)1, AOAC etc. will be discussed.


Why you should attend:
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"For various Analytical and Test Methods, a goal oriented pathway with proper design prior to development activities will help build Quality into the Method from the inception (QbD) and Validation helps to demonstrate that the desired Method is Fit For The Purpose. A Risk based strategy is needed to Develop and apply them for their intended purpose during the entire Life Cycle of such Methods" This presentation follows a progressive, time tested structure over the duration of 2 Days with a Breakout session for 2andHalf Hours on the 2nd Day, which involves Group participation ,with real analytical problem solving and Method Development and generate an appropriate Validation schematics and the Validation Protocol.



For more information: https://www.eventbrite.com/e/a-risk-based-strategy-for-the-development-validation-ntz-tickets-42944031755?aff=RMV


Areas Covered in the Session:
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An overview of global compliance issues, global harmonization initiatives, role of ICH, relevance of Validation activities & the Paradigm Shift

Who will benefit:
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Scientists
Managers
R&D Personnel
Quality Assurance / Quality Control Staff
Validation Managers
Validation Coordinators
Production and Process Development Personnel
Regulatory/Compliance Managers
Chemists
Technicians Study Directors(GLP)
Qualified Persons (EMEA)
Pharmaceutical Development
CRO Staff
CRO Managers
Accredited Laboratories in general, anyone engaged with Test Methods.


Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If your company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.
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For more information: https://www.eventbrite.com/e/a-risk-based-strategy-for-the-development-validation-ntz-tickets-42944031755?aff=RMV


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