Validation of Analytical Methods with a QbD Approach
Conference Dates:
Start Date: 2018-06-04Last Day: 2018-06-05
Deadline for abstracts/proposals: 2018-06-04
Conference Contact Info:
Contact Person: NetZealous LLC DBA GlobalCompliancePanelEmail: [email protected]
Address: Courtyard Seattle Sea-Tac Area 16038 West Valley Highway Tukwila Washington 98188 USA, Seattle, WA, 98188, United States
Tel: 800-447-9407
Fax: 302-288-6884
Conference Description:
Course "A Risk Based Strategy for the Development & Validation of and Validation of Analytical Methods with a QbD Approach" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.Overview:
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. The presentation continually builds on from a conceptual level to practical applications leading to data handling, Data Integrity, Validation Protocol and other documentation, vis-a-vis Regulatory requirements. Discussions provide extensive guidance for preparing Methods Validation Protocols for the various stages of regulatory submissions, e.g. IND, NDA, ANDA, PAI, CMC etc. Various aspects of Laboratory Controls (CGMP), QC procedures, SOPs that cover calibration, standardization, Qualification and Validation, will be included, along with statistical tools, SQC, SPC for processing and monitoring of analytical data. Strategies for the development Stability indicating assays will be touched along with a discussion on Methods Transfer, Spec setting, QC Batch Release, Potency Assays etc.
Location: Seattle, WA Date: June 4th & 5th, 2018 and Time: 9:00 AM to 6:00 PM
Venue: Courtyard Seattle Sea-Tac Area 16038 West Valley Highway Tukwila Washington 98188 USA
Price:
Price: $1,295.00 (Seminar Fee for One Delegate)
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Until May 10, Early Bird Price: $1,295.00 From May 11 to June 02, Regular Price: $1,495.00
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