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      Lifecycle Management of Analytical Methods and Procedures in Daly City

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      February 3, 2020

      Monday   8:30 AM - 4:00 PM (daily for 2 times)

      Daly City, California 94016

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      Lifecycle Management of Analytical Methods and Procedures

      Lifecycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines
      About this Event


      Results of analytical methods are used as the basis for important decisions during development and manufacturing of pharmaceutical products. All regulatory agencies expect the regulated industry to have procedures in place to ensure suitable levels of reliability, accuracy and precision of such methods. The procedures should cover lifecycle phases from design, development, validation to on-going routine use.

      Managing analytical methods and procedures according to the lifecycle approach has been recommended in recent FDA guidance documents and stimuli articles published by the USP. For example, the recent FDA guidance “Analytical Procedures and Methods Validation for Drugs and Biologics” contains a section on Lifecycle Management of Analytical Procedures.

      This 2-day workshop will explain the background to the new Analytical Procedure Lifecycle guidelines and give attendees the knowledge needed to implement recommended approaches. Interactive exercises will be included in the workshop.

      Learning Objectives:

      Learn about the regulatory background and recommendations for managing the lifecycle of analytical methods and procedures
      Understand current and future industry trends: the concept of lifecycle management of analytical methods, recent USP General Chapter 1210 (Statistical Tools for Procedure Validation), and Quality by Design (QbD) principles for method development and validation
      Learn how to plan, execute and document design, development and validation of methods developed in-house
      Understand the principles of lifecycle management for compendial procedures and for managing method transfer
      Be able to develop a strategy for analytical procedure lifecycle management
      Understand risk management strategies throughout the procedure lifecycle
      Understand the concept of measurement uncertainty
      Be able to justify and document decisions about type and extend of revalidation after method changes
      Be able to define and demonstrate FDA, EU, USP and ICH compliance to auditors and inspectors
      Be able to develop inspection-ready documentation during on-going routine operation
      Understand what questions will be asked during audits and inspections and how to answer them
      Seminar Fee Includes:


      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:

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

      DAY 01(8:30 PM - 4:30 PM)

      08.30 AM - 09.00 AM - Registration

      09.00 AM - Session Start

      Introductions and Agenda Review Lectures and Workshop Exercises

      Lecture 1 - Regulatory background and guidance

      The importance of analytical procedures

      Introduction to lifecycle management of analytical methods

      USP approach for method validation: in-process revisions to Chapters 1200, 1210 and 1225

      Learnings from the new FDA, WHO and PDA method validation guidelines

      Linking the procedure lifecycle to the quality system

      The importance of risk management (ICH Q9)

      Lessons from recent FDA Warning Letters

      Recommendations for risk-based implementation

      Lecture 2 - The 2015 FDA Method Validation guidance

      Scope and regulatory status

      Recommendations for integrated procedure lifecycle

      Expectations for quality risk assessment, Quality by Design (QbD), Multivariate experiments, system suitability testing, statistics, knowledge management

      Equipment operational qualification and trend analysis

      Revalidation vs. ongoing evaluation

      Lecture 3 - Preparing your laboratory for compliant validation studies

      Analytical Instrument qualification

      21 CFR 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 4 - The lifecycle overview on integrated method development, validation, and ongoing performance verification

      Advantages of the new approach

      Key steps for design, development, validation and ongoing performance verification

      Integrated lifecycle and QbD: similarities, differences

      Regulatory status of the new approach

      Integrating method transfer and compendial method verification

      Application of risk management through the life cycle

      DAY 02(8:30 AM - 4:00 PM)

      Lectures and Workshop Exercises

      Lecture 5 - The analytical target profile

      Comparison with the scope of current methods

      Advantages and limitations of the ATP approach

      Introduction to measurement uncertainty

      Target measurement uncertainty (TMU)

      Considerations for establishing an ATP

      Incorporating current USP, ICH and FDA guidance into the ATP

      Constructing an ATP for existing methods

      Lecture 6 - Procedure design and development

      Knowledge gathering: what and how

      Risk management: assessment, evaluation and control

      Analytical control strategy

      Typical control examples

      Illustration of controls using Ishikawa (fishbone) diagrams

      Knowledge management as an important factor in ensuring the acquiring, analyzing, storing and disseminating information

      Lecture 7 - Procedure Performance Qualification (Validation)

      Developing a validation/qualification plan and SOP

      Going through ICH Q2 validation and test parameters:

      Accuracy, precision, intermediate precision, specificity, LOD, LOQ, linearity, range, robustness

      Examples for design and execution of test experiments

      Examples of application-specific acceptance criteria

      Evaluation of test results: using statistical models

      Lecture 8 - Ongoing Performance Verification

      Objective of ongoing performance verification

      Monitoring method performance: system suitability testing and quality control samples

      Handling of method changes vs. permitted adjustments

      Revalidation of analytical methods: when, what to test

      Handling of out-of-expectation results

      Continuous improvements


      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.

      Cost: $2,089

      Categories: Conferences & Tradeshows

      This event repeats daily for 2 times:

      Event details may change at any time, always check with the event organizer when planning to attend this event or purchase tickets.