Skip Main Navigation
Page Content

Save This Event

Event Saved

Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)

ComplianceOnline

Monday, November 7, 2016 at 8:30 AM - Tuesday, November 8, 2016 at 4:30 PM (SGT)

Validation, Verification and Transfer of Analytical...

Ticket Information

Ticket Type Sales End Price Fee Quantity
Seminar One Registration (Early bird price)
Registrations after October 20, 2016 - $1999
Nov 7, 2016 $1,599.00 $0.00
Seminar One Registration Nov 7, 2016 $1,999.00 $0.00

Who's Going

Loading your connections...

Share Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)

Event Details

Course Description:

Analytical methods and procedures should be validated to ensure reliability, consistency and accuracy of analytical data. Compendial methods should be verified to demonstrate the suitability of laboratories to successfully run the method and when methods are transferred between laboratories successful transfer should be demonstrated through testing. In case a laboratory wants to use an alternative method instead of a compendial method, equivalency of the alternative method to the compendial method should be demonstrated.

Method validation recently got highest attention from regulatory agencies and industry task forces. For example, FDA and EMA released guidelines on method validation and transfer, and USP has proposed new approaches chapters for integrated validation, verification and transfer of analytical procedures, for equivalency testing and for statistical evaluation.

This 2-day workshop will give attendees the background to understand the requirements, and even more significantly, it will focus on strategies and provide tools to implement most critical requirements. It will also provide templates and examples to develop inspection ready documentation. Interactive workshop exercises will be dispersed into and between the presentations. About 50% of the total time will be dedicated to practical sessions with real life examples. After the course a variety of tools such as SOPs, validation examples and checklists will be readily available on a dedicated website that can be used to easily implement what attendees have learned in the course.

Who will Benefit:

  • QA managers and personnel
  • Quality control
  • Method development
  • Analytical chemists
  • Validation specialists
  • Laboratory managers and supervisors
  • Regulatory affairs
  • Training departments
  • Documentation departments
  • Consultants

 

For Registration -   http://www.complianceonline.com/lab-analytical-compendial-method-ich-q2-glp-part11-annex11-qbd-workshop-seminar-training-80407SEM-prdsm?channel=eventbrite        

 

Note: Use coupon code < NB5SQH8N > and get 10% off on registration.

Have questions about Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)? Contact ComplianceOnline

Save This Event

Event Saved

When & Where


Singapore


Singapore

Monday, November 7, 2016 at 8:30 AM - Tuesday, November 8, 2016 at 4:30 PM (SGT)


  Add to my calendar

Organizer

ComplianceOnline

Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.

Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.

Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.

Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.

  Contact the Organizer
Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)
Seminar Science & Tech

Please log in or sign up

In order to purchase these tickets in installments, you'll need an Eventbrite account. Log in or sign up for a free account to continue.