Boston Professional Events List


2 Days Workshop Analytical Methods Validation for FDA Compliance


Date
Feb 20, 2019 - 08:30 AM - Feb 21, 04:00 PM
Organizer
WCS
Location
(Hilton Garden Inn San Diego / Del Mar),

San Diego,
California,
USA,
ZIP: 92130
Phone: 844-267-7299 | 954-947-5671

Course “Analytical Methods Validation for FDA Compliance “ has been Pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

 

"Each attendee will receive 2-Day workshop materials by the faculty. Seminar Also Includes Certificate, Complimentary Breakfast, Lunch & High Tea/Coffee provided by WCS"

Why have Thousands of companies received warning letters for laboratory control and out-of-specification violations? Improper analytical method validation testing

Thousands of analytical tests are at its heart -- sometimes Hundreds of thousands -- that must be validated and/or verified according to strict FDA protocols and international regulatory agency expectations.

And a warning letter isn't the only consequence of a poor validation system. False passes, poor reducibility, late shipments and production disruptions are all risks you face without a proper validation process in place.

 


 

Session Highlights

Topic 1: Regulatory Requirements/Guidance on Analytical Method

Validation
• Terminology defined: qualification, validation, revalidation and verification
• FDA, EMA, ICH requirements and guidance
• Validation lifecycle for analytical methods

Topic 2: Analytical Method Pre-Validation – Stage 1


• Analytical Target Profile (ATP)
• ICH Q8, Q9 and Q10 adherence - Pre-Validation Requirements
• QC instrumentation qualification
• Training
• Critical assay reagent qualification

Topic 3: Analytical Method Validation Characteristics – Stage 2

• Specificity, accuracy, precision, linearity, range
• LOD and LOQ
• Robustness and stability-indicating
• Value of system suitability controls
Topic 4: Test Method Validation Protocol
• Elements of a validation protocol
• Pre-planning and planning steps
• Identification and documentation of assay characteristics
needing to be validated
• Critical importance of assigning pre-defined acceptance criteria

Topic 4: Test Method Validation Protocol


• Elements of a validation protocol
• Pre-planning and planning steps
• Identification and documentation of assay characteristics
needing to be validated
• Critical importance of assigning pre-defined acceptance criteria

Topic 5: Test Method Validation Report

• Elements of the validation report
• Elements of the validation protocol and the associated final validation report
• Meeting the pre-defined acceptance criteria
• Handling deviations/OOS’s, when (not if) they happen

Topic 6: Regulatory Concerns About Test Method Validations

• Validation issues identified during the review of the submitted
market dossier
• Validation issues identified during regulatory inspections
• Test method validation “continuous improvement” – ICH Q10


 

Who will benefit

• Analytical Development
• Quality Assurance
• Quality Control
Validation 
• Regulatory Affairs
• R&D 
• Technical Operations

All Regulatory affairs personnel responsible for the review of such data will also benefit from this course.




Speaker Details


Ms. Kelly Thomas 

Ms. Kelly Thomas Validation Expert / cGMP Consultant, President KT Consulting. She has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. 

Event Categories
Keywords: pharmaceutical




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