Final Weeks to Register for the 2 Day Lifecycle Management of Analytical Methods and Procedures Course: Current Trends & Your Questions Answered (January 19-20, 2023)

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Jan 05, 2023, 11:15 ET

DUBLIN, Jan. 5, 2023 /PRNewswire/ --The "Lifecycle Management of Analytical Methods and Procedures : Current Trends & Your Questions Answered" training has been added to ResearchAndMarkets.com's offering.

Analytical Methods and Procedures Training Overview

This 2-day course will explain the background to the new Analytical Procedure Lifecycle guidelines and give attendees the knowledge needed to implement recommended approaches.

Results of analytical methods are used as the basis for important decisions during the development and manufacturing of pharmaceutical products. All regulatory agencies expect the pharmaceutical 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 ongoing 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 the Lifecycle Management of Analytical Procedures, and ICH has recently published guidelines on product lifecycle management.

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 the 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 ongoing routine operation
Understand what questions will be asked during audits and inspections and how to answer them

Who Should Attend:

This course is intended for individuals who have the responsibility for establishing the integrity of analytical methods for active pharmaceutical ingredients (APIs) or finished pharmaceutical dosage forms.

This course will benefit individuals in:

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

Key Topics Covered:

DAY 01 (10:00 AM - 5:00 PM EDT)

10.00 AM - Session Start

Introductions and Agenda Review Lectures

Lecture 1 - Regulatory background and guidance

The importance of analytical procedures
ICH Q12
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 (10:00 AM - 5:00 PM EDT)

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
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

The 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

For more information about this training visit https://www.researchandmarkets.com/r/gk07a4

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Research and Markets
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[email protected]

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SOURCE Research and Markets