ComplianceOnline

“The Compliance Certification Board (CCB)® has approved this event for up to 13.8 live CCB CEUs. Continuing Education Units are awarded based on individual attendance records. Granting of prior approval in no way constitutes endorsement by CCB of this event content or of the event sponsor.”

Analytical methods used for GxP purposes 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. Lifecycle management has also been the subject of recent FDA and ICH publications.

This 2-day seminar 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.

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

In-Person Seminar going Virtual with increased learner satisfaction.

Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:

Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:

  • The real-time and live presentation as in in-person events
  • Private chat for company-specific conversation – the same as you would get in an in-person seminar
  • Opportunities to connect with your peers to share knowledge at a different time and have group discussions
  • Live workshop activities
  • Live Q&A during the event and offline Q&A assistance after the event
  • As usual more content, activities and case studies and now adding homework for a comprehensive understanding
  • Certification

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(10:00 AM - 5:00 PM EDT)
  • 10:00 AM Session Start
  • Day 1 – Lectures and Workshop Exercises
  • Lecture 1: Regulatory Background and Requirements
    • FDA, EMA and international requirements (ICH Q2, ICH Q12 and the proposed ICH Q14)
    • Method validation terminology
    • USP and Ph Eur guidance on method validation, verification and transfer:
    • 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)
  • 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
  • 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
Day 02(10:00 AM - 5:00 PM EDT)
  • 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
  • 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
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
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

(One Dial-in One Attendee)

(After registration, we will video stream the training on your convenient dates)

$11,999.00

Group-Max. 10 Attendees

(After registration, we will video stream the training on your convenient dates)



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Payment:

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 for In-person Seminars:

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.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Cancellations and Substitutions for Virtual Seminars & Webinars:

Written cancellations through fax or email (from the person who has registered for the training) received at least 10 calendar days prior to the start date of the event will receive a refund — less a 30% administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event. On request by email or fax (before the training) a credit for the amount paid minus administration fees (30%) 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. Some topics and speakers may be subject to change without notice.
Offers:
  • Early bird seats are limited and based on first-come, first-serve.
  • Multiple offers cannot be combined.
  • Lab Compliance Seminar by Speaker: Understand guidelines from FDA/EMA, USP and ICH

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

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

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    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.

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    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.

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