Lifecycle Management of 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 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.


DAY 01(10:00 AM to 17:00 PM)

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 to 17:00 PM)

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

  • 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

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 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

Participant Testimonials

Thank you for providing the information in such detail. It was helpful to gain the perspective of somebody who has implemented these regulations in a working lab. The materials which I received also helped a lot.

Tracey Kessler, Director of R&D, CEL-SCI Corp

Attendee Question from our past Training

Are vendors OQ worth the price? I have been told that FDA will not look at vendor OQ than the internal OQ?

Faculty Response The answer is yes because they have expertise necessary to ensure that the system they have designed, provided and delivered to you is operating in accordance with user specifications. Now if the system validation is new to everyone in your organisation than it is highly suggested that you can built the skill set for maybe in the future to do it in house. Now the only one thing you have to understand is that the FDA is a regulated body and it still do expect your QA units, your internal unit to check the OQ and make sure if is compliant and make sure that it is sufficient in covering all of the areas so you just can't blindly accept the OQ without the same additional oversight. So it really does depend on the expertise your group has and level of validation experience.

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Kelly Thomas CGMP Trainer

Kelly Thomas (25+ year exp.)

Vice President, Americas Quality Operations at Stallergenes Greer - Charlotte Metro USA

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.  

Our Participants Testimonial

The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterward about it. ( FDA Compliance and Mobile Applications Webinar )

Robert Friedland ( IT Manager) NUTEK BRAVO, LLC.

I felt the seminar was very helpful and provided good insight for DataIntegrity and what the FDA is looking for per the regulations. ( Current Regulatory Thinking on Data Integrity 2 Days Virtual Seminar )

Margaret A. Clifton ( Manager, Quality Systems) CSL Plasma

The presenters subject matter knowledge is extensive which enables information to be shared in detail. (Training Attended on Risk Based Verification and Validation Planning to Meed US FDA and ISO 13485 Requirements )

Stuart Chisholm (Sr. Principal Device Engineer) Teva Pharmaceuticals