LIVE Webinar

Goals and Objectives

This two interactive session webinars are designed to offer a lifecycle approach to assuring analytical methods are suitable for their intended use. After an introduction to the stages of an analytical method, we will discuss each stage in more detail including concepts and practical suggestions. We will use concepts from personal experience, from ICH and USP documents as well as some additional concepts from a recent paper on a QbD approach to method lifecycle. The course will address specific requirements for chromatographic methods intended for monitoring impurities and degradates, chromatographic methods where the focus is on measuring the active ingredient and non-chromatographic methods. There will be opportunity for participant questions at the end of the course.

Upon completion of the course the learner should be able to:

• Identify the various stages in the lifecycle of an analytical method and the expectations at each of those stages
• Apply the concept of the Analytical Target Profile for improving the design and evaluation of analytical methods
• Approach method development using the Analytical Target Profile as a tool to increase the effectiveness of the exercise
• Discuss the appropriate guidance documents related to method validation, verification and transfer
• Identify the required elements for method validation, verification or transfer experiments

• Introduction:  Using a Lifecycle Approach for Analytical Procedures
• Method Design:  Introducing the concept of the Analytical Target Profile
• Method Development:  Based on the ATP and adapting existing methodology, consider development as a process which anticipates validation needs and uses a QbD approach to exploring limits for enhancing method understanding
• Assay or Uniformity
• Dissolution
• Stability indicating methods
• Method Validation:  Applying the concepts of ICH Q2 and USP <1225>
• Rationale for demonstrating the validity of an analytical method
• Life cycle approach to method validation
• Early development
• Later development
• Transfer to other laboratories
• Verification of methods from outside sources, including Compendia
• Design of validation experiments
• Chromatographic methods designed to be selective for impurities and degradates
• Chromatographic methods designed to measure the primary component
• Non-chromatographic methods

A brief review of Series 1 will be discussed and a Q&A opportunity will follow.

• Method Modifications:  Understanding the rationale for change and addressing effective change control and method revalidation strategies
• Method Verification:  Understanding the requirements when a compendial or similar method is brought into the laboratory and the data elements which must be addressed to verify the method is suitable for its intended use.
• Method Transfer:  Identifying acceptable approaches to transfer of methods between laboratories, data elements which must be addressed and appropriate documentation.
• Questions and discussion

Chemists, supervisors, managers or directors from pharmaceutical companies, generic companies or contract research organizations who are responsible for development, validation, verification or transfer of analytical methods, and regulatory affairs/CMC personnel responsible for filings involving analytical methods.

Single Attendee: CAD $195.00

Group of 5 or less per location: CAD $400.00
Group of 6 to 10 attendees per location: CAD $750.00
Group of 11 to 20 attendees per location: CAD $1250.00

Single attendee refers to single participant at a single computer/login.

Group rates only apply to candidates who wish to have more than one attendee, but will be attending the webinar from a single computer/login. If multiple candidates wish to login at different locations, it will be considered as a separate additional registration and will require more than one webinar login information. Also note that one login information will only be valid on one computer.

Please contact us at webinar@ipacanada.com for multiple-location group rates or any other enquiries