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Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH): 2-Day Workshop by Dr. Huber

By:
Dr. Ludwig Huber, Chief Advisor - Global FDA Compliance, Labcompliance
Location:-
Radisson Blu Hotel Dublin Airport, Ireland
| Thursday, October 13, 2016 | Friday, October 14, 2016

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.


Learning Objectives:

  • Learn about the regulatory background and requirements for validation of analytical methods and procedures
  • Learn how to plan, execute and document development and validation of methods developed in-house
  • Be able to explain the different requirements for validation, verification and transfer of analytical procedures
  • Understand the principles of validating methods developed in-house, verification of compendial methods, transfer of analytical procedures and demonstrating equivalency to compendial methods
  • Be able to explain your company’s strategy for method validation, verification, transfer and equivalency testing
  • Be able to select test parameters, test conditions and acceptance criteria for different analytical tasks
  • Be able to justify and document decisions about revalidation after method changes
  • Be able to define and demonstrate FDA and EU compliance to auditors and inspectors
  • Be able to develop inspection ready documentation during on-going routine operation
  • Understand statistical evaluation of validation test results
  • Understanding what questions will be asked during audits and inspections and how to answer them

Handouts/ Bonus Material for Easy Implementation (available as web downloads):

  • 70-page primer: Validation of analytical methods (authored by Dr. Ludwig Huber)
  • 10 SOPs related to validation, verification, transfer, review and change of analytical methods
  • 10 checklists, templates and examples
  • Acceptance criteria for different analytical tasks

Seminar Fee Includes:

Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar



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




Course Outline:

Day One (8:30 AM - 4:30 PM) Day Two (8:30 AM - 4.30 PM)

8:30 AM - 9:00 AM: Registration Process

9:00 AM: Session Start

Day 1 – Lectures and Workshop Exercises

Lecture 1
Regulatory Background and Requirements

  • FDA and international requirements
  • The importance of ICH Q2 and USP chapters
  • USP approach for method validation: New/revised Chapters 220, 1200, 1210, 1220, 1225
  • Learnings from the NEW FDA and WHO method validation guidelines
  • Different requirements for GLP, GCP and GMP
  • The importance and steps of risk assessment
  • Exercise: Define risk numbers for different methods
  • Lessons from recent FDA Warning Letters
  • Planning for cost-effective implementation

Lecture 2
Preparing Your Lab for Validation Studies

  • Analytical Instrument qualification
  • Part 11/Annex 11 compliance of computer systems
  • Validation of chromatographic data systems
  • Validation and control of Excel spreadsheets
  • Qualification of reference standards and materials

Lecture 3
Validation of Analytical Methods and Procedures

  • Developing a validation plan and SOP
  • ICH Q2 validation and test parameters:
  • Accuracy, precision, intermediate precision, specificity, LOD, LOQ, linearity, range, robustness, ruggedness
  • Examples for application specific acceptance criteria
  • Examples for design and execution of test experiments
  • Evaluation of test results: using statistical models
  • Handling deviations from expected test results
  • Going through an example validation report

Lecture 4
Verification of Compendial Methods

  • FDA and equivalent international expectations
  • Scope and objectives of USP <1226>
  • USP <1226> verification requirements
  • Risk based approach for type and extent of verification testing
  • Which validation parameters should be verified
  • Logical process to set acceptance criteria
  • Exercise: Application based verification testing

Day 2 – Lectures and Workshop Exercises

Lecture 5
Transfer of Analytical Methods and Procedures

  • The main objective of formal method transfer
  • Learnings from EU GMP Chapter 6 on method transfer
  • USP <1224> : Choosing the approach for transfer
  • Approach and benefits of comparative testing:
  • Developing a risk based test plan
  • Planning and developing an effective transfer protocol
  • Preparing the receiving lab for the transfer
  • Method transfer to new technology:: HPLC to UHPLC
  • Preparing the method transfer report
  • Exercise: Application specific comparative testing

Lecture 6
Demonstrating Equivalency to Compendial Methods

  • Method validation vs. equivalency testing
  • Definition, objective and scope of alternative methods
  • Justification for the use of alternative methods
  • FDA and USP requirements
  • Options for alternatives to approved procedures
  • Exercise: Equivalency testing - what and how much
  • Documentation requirements

Lecture 7
Maintaining the Validated State

  • Monitoring method performance: system suitability testing and quality control samples
  • Change control procedure for analytical methods
  • Handling method changes vs. adjustments
  • Revalidation of analytical methods: when, what to test
  • Method reviews as a cost effective alternative to time based revalidation
  • Going through a review process
  • Regulatory reporting of post-approval changes
  • Examples for continuous improvements

Lecture 8
Special Applications and Validation Processes

  • Preview to the expected new USP general chapter <1220> “The Analytical Procedure Lifecycle”
  • Method development and validation using Quality by Design principles following the new FDA Guidance
  • Validation of bioanalytical methods according to the FDA and EMA guidelines
  • Validation of stability indication method



  • 50 % of the time will be dedicated to workshop type exercises using prepared fill-in templates and to interactive discussions


Meet Your Instructor

Dr. Ludwig Huber
Chief Advisor - Global FDA Compliance, Labcompliance
  • Chairman, presenter and panel discussion member at US-FDA Industry Training sessions and conferences
  • Served as team member of PDA's task forces "21 CFR Part 11", of US-FDA internal documents, and of the GAMP® special interest group on Laboratory Systems.
  • Presenter of the Year of the Institute for Validation and Technology
  • Director and chief editor of www.labcompliance.com, the global on-line resource for validation and compliance issues for laboratories.
  • Author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems"

For more information, visit www.ludwig-huber.com/qualification





Register Online

$1,899.00

Seminar One Registration (USD)

October 13-14, 2016, Dublin, Ireland
(Registrations till September 30, 2016 - $1899)
(Registrations after September 30, 2016 - $1999)

$2,299.00

Seminar One Registration (With 2 Nights Stay)

October 13-14, 2016, Dublin, Ireland

$8,799.00
$11,394.00
You Save: $2,595.00 (22%)*

Special Group Discount Register for Six attendees (USD)

October 13-14, 2016, Dublin, Ireland
*Hurry! This option is limited and based on availability.
Great Savings with Group Ticket!!! Only 3 left



Early bird seats are limited and based on first-come, first-serve.

The registration fee includes: the workshop; all related course materials; morning tea/coffee, lunch and afternoon tea/coffee on both the days.


For discounts on multiple registrations, contact customer care at +1-888-717-2436.

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Venue

Location:


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How to Reach

General Driving Directions:

Driving Directions from Dublin Airport:
  • Head south-west - 4 m
  • Continue straight - 450 m
  • Turn left onto R132 - 600 m
  • At the roundabout, take the 1st exit - 400 m
  • Slight left - 73 m
  • Turn left - 54 m
  • Turn left. Destination will be on the right

Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. ComplianceOnline is not responsible for any inaccuracies in the same.





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Local Attractions

Kilmainham Gaol is a former prison in Kilmainham, Dublin, Ireland. It is now a museum run by the Office of Public Works. Many Irish revolutionaries, including the leaders of the 1916 Easter Rising, were imprisoned and executed in the prison by the British. Kilmainham Gaol was decommissioned as a prison by the Irish Free State government in 1924. Later, final restorations of the site were completed in 1971 when Kilmainham Gaol chapel was re-opened to the public having been reroofed and refloored and with its altar reconstructed. It now houses a museum on the history of Irish nationalism and offers guided tours of the building. An art gallery on the top floor exhibits paintings, sculptures and jewelry of prisoners incarcerated in prisons all over contemporary Ireland. Kilmainham Gaol is one of the biggest unoccupied prisons in Europe. Now empty of prisoners, it is filled with history. It has aptly been described as the 'Irish Bastille'.




Phoenix Park is an urban park in Dublin, lying 2–4 km west of the city centre, north of the River Liffey. Its 11 km perimeter wall encloses 1,750 acres, one of the largest walled city parks in Europe. It includes large areas of grassland and tree-lined avenues. There are 351 identified plant species in the park; three of these are rare and protected. The park has retained almost all of its old grasslands and woodlands and also has rare examples of wetlands. Deer were introduced into the park in the 1660s; the current 400–450 fallow deer descend from the original herd. The park also contains several sports grounds for football, hurling, soccer, cricket and polo.




The National Museum of Ireland is the national museum in Ireland. It has three branches in Dublin and one in County Mayo, with a strong emphasis on Irish art, culture and natural history. The National Museum of Ireland – Archaeology on Kildare Street has displays on prehistoric Ireland, including early work in gold, church treasures and objects from the Viking and medieval periods. The Kingship and Sacrifice exhibition includes well preserved bog bodies and Ralaghan Man. There are special displays of items from Egypt, Cyprus and the Roman world, and special exhibitions are regularly mounted.




Saint Patrick's Cathedral in Dublin, also known as The National Cathedral and Collegiate Church of Saint Patrick, Dublin, was founded in 1191. It is the largest church in Ireland and one of Dublin's two Church of Ireland cathedrals. It has a 43-metre spire. Christ Church, the other cathedral, is the diocesan cathedral of the diocese of Dublin and Glendalough. The cathedral has over 300,000 visitors a year. Throughout its long history the cathedral has contributed much to Irish life, and one key aspect of this relates to the writer and satirist Jonathan Swift, author of Gulliver's Travels, who was Dean of the cathedral from 1713 to 1745. Many of his famous sermons and "Irish tracts" (such as the Drapier's Letters) were given during his stay as Dean. His grave and epitaph can be seen in the cathedral, along with those of his friend Stella.




The Chester Beatty Library was established in Dublin in 1950, to house the collections of mining magnate, Sir Alfred Chester Beatty. The present library, on the grounds of Dublin Castle, opened on February 7, 2000, the 125th anniversary of Beatty's birth and was named European Museum of the Year in 2002. The library's collections are displayed in two collections: "Sacred Traditions" and "Artistic Traditions". Both displays exhibit manuscripts, miniature paintings, prints, drawings, rare books and some decorative arts from the Islamic, East Asian and Western collections. The library is one of the premier sources for scholarship in both the Old and New Testaments and is home to one of the most significant collections of Islamic and Far Eastern artefacts. The museum also offers numerous temporary exhibitions, many of which include works of art on loan from foreign institutions and collections. The museum contains a number of priceless objects, including one of the surviving volumes of the first illustrated Life of the Prophet and the Gospel of Mani believed to be the last remaining artefact from Manichaeism.






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