ComplianceOnline

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

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
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
  • 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

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
  • Consultants
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
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
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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 16-17, 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.


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Location

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

September 16-17, 2019

How to Reach

General Driving Directions:

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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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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