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Validation of Analytical Methods with a QbD Approach

Event Details

Validation of Analytical Methods with a QbD Approach

Time: June 4, 2018 at 9am to June 5, 2018 at 6pm
Location: Courtyard Seattle Sea-Tac Area
Street: 16038 West Valley Highway Tukwila Washington 98188 USA
City/Town: Seattle
Website or Map: https://www.globalcompliancep…
Phone: 800-447-9407
Event Type: seminar
Organized By: John Robinson
Latest Activity: Apr 26

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Event 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)

Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*

 Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*

Register now and save $200. (Early Bird)

Until May 10, Early Bird Price: $1,295.00 From May 11 to June 02, Regular Price: $1,495.00

Sponsorship Program benefits for “Validation of Analytical Methods with a QbD Approach

” seminar

For More Information- https://www.globalcompliancepanel.com/control/sponsorship 

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel

john.robinson@globalcompliancepanel.com  

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

 

Registration Link - https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901645SEMINAR?SEO

 

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanelindia/

Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

Follow us on Twitter: https://twitter.com/GCPanel

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