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4th Edition Conference

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

23 - 24 Mar 2020  New Date Reminder

About Followers 8 Reviews Exhibitors Photos 4 Speakers 2 Travel Deals
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"Understand the regulatory requirements for validation of analytical methods"
Analytical methods should be validated to ensure the 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 or a transfer waiver, if justified. If a laboratory uses an alternative method instead of a compendial method, equivalence or superiority of the alternative method should be demonstrated.Recent guidance on method validation and transfer has been produced by FDA and EMA, and USP has guidance chapters on method validation, verification and transfer, equivalence testing and statistical evaluation. Articles in US Pharmacopeial Forum have introduced the concepts of measurement uncertainty and lifecycle management for analytical procedures.

Highlights

  • Recent FDA and EMA enforcement action regarding method validation,FDA, EMA and international ICH Q2
  • Recent FDA and EMA enforcement action regarding method validation,Method validation terminology
  • Recent FDA and EMA enforcement action regarding method validation,EU GMPs: Chapter 6 and Annex 15
  • Transfer of Analytical Methods and Procedures,Preparing the receiving laboratory for method transfer
  • Maintaining the Validated State (Lifecycle Management),Change control for analytical methods

Timings

8:30 AM - 4:30 PM (Mar 23) (General)
8:30 AM - 4:30 PM (Mar 24) (General)

Entry Fees

Paid Ticket Starts from 1899 USD View Details

Participants

20
Delegates

5 Exhibitors Estimated Count

Category & Type

Conference
Medical & Pharma

Editions

23 - 24 Mar 2020 4th Edition
18 - 19 Jul 2019 3rd Edition
09 - 10 Oct 2017 2nd Edition
09 - 10 Feb 2017 1st Edition
View More

Frequency Bi-annual
Next edition likely in Sep 2020

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Organizer

Logo Follow Company

ComplianceOnline USA

Top Rated 519 Total Events / 163 Upcoming Events

User Community [ Users who have shown interest for this Event ]

Mohammad Rafi Rafiqzada

Mohammad Rafi Rafiqzada

Security Coordinator at World Health Organization Afghanistan

Kabul, Afghanistan
Mustafa Rezwan

Mustafa Rezwan

Procurement Assistant at WHO

Kabul, Afghanistan
Alireza Mostaghimi

Alireza Mostaghimi

Quality Assurance at Genentech

South San Francisco, United States
Omid Norouzi

Omid Norouzi

Procurement Assistant at RORA

Kabul, Afghanistan
dan schindler m.d

dan schindler m.d

HONK KONG at DR DAN SGHINDLER LTD

Ashdod, Israel
Mohammed Magdi Ibrahim

Mohammed Magdi Ibrahim

Pharmacist at Dermazone Drug Store Llc

Dubai, United Arab Emirates
Lia Suci Kriswanti

Lia Suci Kriswanti

Yogyakarta, Indonesia

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Speakers

Speaker
Mark Powell

Mark Powell

#Training and #consultancy services in #analytical #chemistry
Speaker
Mark Powell

Mark Powell

Director

Visitor Ticket Price

1899 USDAttendee Seminar One Registration
37.578000 -122.348000

Venue Map & Directions

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Venue to be announced

Burlingame, USA

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