2-Day Virtual Seminar

Wednesday, February 03, 2021, 10:00 AM EST - 05:00 PM EST

Thursday, February 04, 2021, 10:00 AM EST - 05:00 PM EST

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 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, and ICH has recently published guidelines on product lifecycle management.

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.

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 on-going routine operation
• Understand what questions will be asked during audits and inspections and how to answer them.

Agenda:-

Day 1 (10:00 AM - 5:00 PM EST)

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
• The regulatory status of the new approach
• Integrating method transfer and compendial method verification
• Application of risk management through the life cycle

DAY 2 (10:00 AM - 5:00 PM EST)

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 of 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

Who Will Benefit?

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