Lifecycle Management of Analytical Methods and Procedures According to New FDA and USP Guidelines (Boston, United States - September 16-17, 2019)
DUBLIN, Aug. 29, 2019 /PRNewswire/ -- The "Lifecycle Management of Analytical Methods and Procedures - According to New FDA and USP Guidelines" conference has been added to ResearchAndMarkets.com's offering.
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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.
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.
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
Who Should Attend:
-- 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
Agenda:
Day 1
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 2
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
For more information about this conference visit https://www.researchandmarkets.com/r/vojjzd
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