ComplianceOnline

“This education activity has been submitted to the Compliance Certification Board (CCB)® and is currently pending their review for approval of CCB CEUs.”

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.

This 2-day workshop will help attendees to understand regulatory requirements for method validation, verification and transfer. It will also suggest ways to de-risk the method validation process through prior evaluation of method performance and the use of effective protocols. The course includes workshops to help attendees plan method validation and to select appropriate acceptance criteria, as well as checklists for validation protocol and analytical method contents.

Learning Objectives:

  • Understand the regulatory requirements for validation of analytical methods
  • Learn how to plan, execute and document development and validation of in-house methods
  • Be able to explain the different requirements for validation, verification and transfer of analytical procedures
  • Understand the principles of validation of in-house methods, verification of compendial methods and method transfer
  • Know how to demonstrate equivalence to compendial methods
  • Understand the important qualities of stability-indicating methods
  • Be able to select test parameters, test conditions and acceptance criteria for different analytical measurements
  • Know how to plan, justify and document revalidation after method changes
  • Understand important indicators of the suitability of a method for routine QC use
  • Understand approaches for the statistical evaluation of validation test results
  • Understanding what questions will be asked during audits and inspections and how to answer them
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Who will Benefit:

  • Quality assurance personnel
  • Quality control and method development analysts
  • Validation specialists
  • Laboratory managers and supervisors
  • Regulatory affairs personnel
  • Consultants
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(8:30 AM - 4:30 PM)
  • 8:30-8:59 Registration Meet & Greet.
  • 9:00 AM Session Start
  • Day 1 – Lectures and Workshop Exercises
  • Lecture 1: Regulatory Background and Requirements
    • FDA, EMA and international requirements (ICH Q2)
    • Method validation terminology
    • Compendial guidance on method validation, verification and transfer:
    • USP General Chapters 1033, 1092, 1210, 1224, 1225, 1226 and 1467
    • Ph. Eur. 5.21 – Chemometric Methods applied to Analytical Data
    • EU GMPs: Chapter 6 and Annex 15
    • Recent FDA and WHO method validation guidelines
    • Different requirements for GLP, GCP and GMP
    • Recent FDA and EMA enforcement action regarding method validation
    • Introduction to quality risk management (ICH Q9)
    • Exercise: evaluating risk in method validation, verification and transfer
  • Lecture 2: Preparing for Method Validation
    • Analytical Instrument qualification (USP <1058>)
    • Computerized data systems (21 CFR 11, EU GMPs Annex 11 and GAMP 5)
    • Validation of chromatographic data systems
    • Validation and control of Excel spreadsheets
    • Qualification of reference standards and materials
    • Evaluating method performance prior to validation
  • Lecture 3: Validation of Analytical Methods
    • Developing a validation plan and SOP
    • Phase-appropriate method validation
    • Experimental approaches to method validation: accuracy, precision, intermediate precision, specificity, LOD, LOQ, linearity, range and robustness
    • Demonstrating specificity: stress studies and impurity standards
    • Dealing with validation failures
    • Exercise: example validation report
  • Lecture 4: Verification of Compendial Methods
    • Scope, objectives and requirements of USP <1226>
    • Changes allowed to chromatographic methods: USP <621> and Ph. Eur. 2.2.46
    • Risk-based approach to method verification - which validation parameters should be verified?
    • Method verification acceptance criteria
    • Exercise: planning a method verification exercise
Day 02(8:30 AM - 4:30 PM)
  • Day 2 – Lectures and Workshop Exercises
  • Lecture 5: Transfer of Analytical Methods and Procedures
    • Method transfer objectives
    • Method transfer approaches
    • Risks in method transfer
    • Writing an effective transfer protocol
    • Preparing the receiving laboratory for method transfer
    • Method transfer to new technology: HPLC to UHPLC
    • The method transfer report
    • Exercise: planning a method transfer exercise using comparative testing
  • Lecture 6: Demonstrating Equivalence to Compendial Methods
    • Method validation vs. equivalence testing
    • Definition, objective and scope of alternative methods
    • Justification for the use of alternative methods
    • FDA and USP requirements
    • Equivalence testing - what and how much?
    • Documentation requirements
  • Lecture 7: Maintaining the Validated State (Lifecycle Management)
    • Monitoring method performance: system suitability testing and quality control samples
    • Change control for analytical methods
    • Handling method changes pre- and post-approval
    • Revalidation of analytical methods: when, and what to test
    • Method review
    • Continuous improvement
  • Lecture 8: Recent Developments
    • Lifecycle approach to analytical methods
    • Method development and validation using Quality by Design principles
    • Validation of bioanalytical methods according to the FDA and EMA guidelines
    • Measurement uncertainty
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Mark Powell

Mark Powell
Director, Mark Powell Scientific Limited

Dr Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as an analytical chemist. Mark was Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016, when his term of office ended. Between 2003 and 2013, he was the Analytical Development Manager, and later Scientific Manager, of a UK-based contract research organization which specialized in early-stage oral drug development. During this time, he was responsible for method validation, verification and transfer activities, as well as the qualification of laboratory instruments and computerized data systems. In 2013, he set up Mark Powell Scientific Limited, which provides training and consultancy services to pharmaceutical companies. Mark has since enjoyed working with companies of all sizes around the world on a variety of training and consultancy assignments, and has recently co-authored a White Paper on Pharmaceutical Data Integrity for the laboratory supply company VWR.

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$1,899.00

Seminar One Registration

September 19-20, 2019, Boston, MA




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.

Other Registration Option

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Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

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After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

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Location

Boston College Club
100 Federal Street, 36th Floor
Boston, MA 02110, USA
Tel: +1-617-946-2828

September 19-20, 2019

How to Reach

General Driving Directions:

Driving Directions from Boston Logan International Airport
  • Continue to Airport Rd - Arrival Level
  • Get on MA-1A S
  • Use the right lane to turn slightly right to stay on Airport Rd - Arrival Level
  • Use the right lane to turn slightly right
  • Keep right at the Y junction, follow signs for MA-1A S/Interstate 93 N/Sumner Tunnel
  • Continue on MA-1A S. Drive to Congress St
  • Continue onto Congress St
  • Destination will be on the right
Select hotels close to meeting venue:
  • Club Quarters Hotels | 161 Devonshire St, Boston, MA 02110, USA | clubquartershotels.com | 617-357-6400
  • 4 min walk | Hyatt Centric | 54-68 Devonshire St, Boston, MA 02109, USA | hyatt.com | 617-720-1234

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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Lab Compliance Seminar by Speaker: Understand guidelines from FDA/EMA, USP and ICH

Testimonials

See What People Say About Us

Speaker is very knowledgeable and the supporting material provided by him is very helpful.

SQA Compliance Auditor,

AbbVie Inc.

There is sufficient information in the seminar and the presenter is very professional.

Head of Quality,

Bayer HealthCare.

Definition of raw data and its relationship of e-signature application topic was most valuable to me as we were evaluating the gap in our company and this handy data before doing that will help us to get the requirement.

Assistant Manager,

QA, SHL Group Limited

Information and resources provided by Speaker is very informative. Additional resources provided by him has practical and applicable approach. What I have learned will be helpful in reinforcing compliance in the company with QA.

Assistant Manager,

Quality Assurance, EirGenix, Inc

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For more details and other sponsorship options at this event, please contact Event Manager: customercare@complianceonline.com or call: +1-650-238-9656

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Local Attractions of Boston, MA

Boston Public Garden

Boston Public Garden

This Frederick Law Olmsted-designed park, famous for its Swan Boats, has over 600 varieties of trees and an ever-changing array of flowers. It is America's first public garden.

Boston Public Library

Boston Public Library

The Boston Public Library was the first large municipally-funded public library in America. It has a central location right in the heart of Copley Square, facing the Trinity Church, easily accessible by taking the Green Line to Copley station (or also near to Orange Line Back Bay stop).

Fenway Park

Fenway Park

Fenway Park is the oldest Major League baseball park in the United States. Its small, intimate atmosphere really allows you to feel like you are "in the game." The park is situated right in downtown Boston - so it is very accessible if you are visiting the area.

Museum of Fine Arts

Museum of Fine Arts

Boston's oldest, largest and best-known art institution, the MFA houses one of the world's most comprehensive art collections and is renowned for its Impressionist paintings, Asian and Egyptian collections and early American art.

Museum of Science

Museum of Science

The Boston Museum of Science is a long-standing tradition for families in Boston, but that doesn't mean adults won't enjoy themselves too! Their exhibits range from dinosaurs to space travel to wildlife to physics to human biology to an in-depth look at Boston's "Big Dig" project.

North End

North End

This Italian neighborhood, Boston's oldest, is known for its wonderful restaurants and historic sights.

Old North Church

Old North Church

The signal from the steeple of Boston's oldest church triggered the War for Independence that led to the birth of America. On that fateful night in 1775, the two lanterns in the steeple told Paul Revere that the British were approaching by boat, not on foot.

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