Online Safety Community

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, 2018

Export to Outlook or iCal (.ics)

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

Comment Wall

Comment

RSVP for Validation of Analytical Methods with a QbD Approach to add comments!

Join Online Safety Community

Attending (1)

Take our poll!

Take our poll!

Forum

Workplace safety for workers other than your own 3 Replies

Do your workplace/traffic safety plans include safety measures for workers who are not your own employees? Do they take into account the safety of those who will be - or could be - at your workplace,…Continue

Tags: emt, paramedics, emergency, occupational, health

Started by John Petropoulos Memorial Fund. Last reply by Paul Lancaster May 28.

Imagine a technology which is an artificial muscle and is integrated into textiles...

Such a smart textile has huge application potential and can support people in many different ways. The garment would use haptic feedback (i.e. the use of touch to guide the user) or could serve as a…Continue

Started by Ulla Siegel May 28.

Green Smart Technical 800+ Turnkey Projects in UAE – Rope Access Company in Dubai

Green smart is an ISO 9001: 2015 QMS, OHSAS 18001: 2017 OHSMS, ISO 14001: …Continue

Tags: window, cleaning, services, facade, companies

Started by Manikandan Apr 23.

What % of Dollars should be bugeted for All Safety Training for a "Heavy Equipment Road Construction" company with 100 employees? 1 Reply

I have been at a Highway and Road Construction company for six months. I am developing a (first) complete training program. I am the 1st full time safety hire for this company. I need to develop a…Continue

Started by JTurpening. Last reply by Jen McDade Feb 19.

Technology and Safety 1 Reply

What are the most useful tools to have at your fingertips? -Toolbox Talks-JSA-JHA-Daily Reports, etc. What is falling through the cracks that could be an easy fix? Safety Managers, Coordinators and…Continue

Tags: safety

Started by Drew stone. Last reply by Jen McDade Feb 15.

Badge

Loading…

© 2019   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service