Course Overview

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.


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

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.

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.



Agenda

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

  • 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
Kelly Thomas

Kelly Thomas


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.  

Choose a Pricing Option

$1,699

One Dial-in One Attendee

Registrations till 22 Jan, 2021 - $1699 Registrations after 22 Jan, 2021 - $1899

$2,950

Corporate Live – Group ( Training DVD Free )

Up to 5 Dial In is allowed from home or office . Training DVD by download will be shared within 24 hrs.

$1,895

Recorded Access Corporate Group

You'll have access to group log-in for an archived recording of the entire 2 day virtual seminar including the Q&A period, for 1 location. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session