Course Catalog

Analytical Method Transfer of Pharmaceutical Products

Analytical methods are a major tool in the pharmaceutical development to control the quality and integrity of the active drug substance or drug product. Methods are normally developed at one site and then transferred to one or more sites during the drug development process. Qualifying analysts to perform these methods is a critical activity that would significantly impact the launch of a product. Activities of a method transfer process must be managed effectively to deliver an analytical method from one site to another or one department to another. This course will present fundamental principles of a method transfer, examine different strategies, discuss key factors that would influence the transfer of analytical methods from one site to another.

 

Course Details

Key Topics

  • Planning and developing an effective transfer protocol
  • Exploring key process steps that are site dependent
  • Selecting appropriate strategies for method transfer
  • Providing a framework to improve the success of method transfer
  • Understanding method capabilities to set acceptance criteria

Information

Analytical methods are a major tool in the pharmaceutical development to control the quality and integrity of the active drug substance or drug product. Methods are normally developed at one site and then transferred to one or more sites during the drug development process. Qualifying analysts to perform these methods is a critical activity that would significantly impact the launch of a product. Activities of a method transfer process must be managed effectively to deliver an analytical method from one site to another or one department to another. This course will present fundamental principles of a method transfer, examine different strategies, discuss key factors that would influence the transfer of analytical methods from one site to another.

Registrants will need to purchase a copy of Handbook of Stability Testing of Pharmaceutical Products: Regulations, Methodologies and Best Practices by Huynh-Ba (Springer, 2008) in addition to registration.

Who Should Attend

This course will benefit analytical chemists, QC chemists, regulators, researchers who are involved in the technology transfer of pharmaceutical products.

You must have at least 2 years of experience in pharmaceutical industry to get the full benefit of this course.

Benefits

  • Understand key factors of analytical method transfer
  • Develop appropriate transfer strategy
  • Standardize transfer process to establish method performance
  • Develop project plan and monitor timelines

Agenda

Overview of the Method Transfer Process

  • Purpose of Analytical Method Transfer
  • Strategies of Method Transfer
  • Phases of Method Transfer
  • Determine Gap Analysis

Preparation Phases of Method Transfer

  • Contents of method transfer package
  • Training options involving method transfer
  • Determine impacts on the transfer process

Establishing Method Transfer protocol

  • Developing Method Transfer protocol
  • Determine acceptance criteria
  • Evaluating and documenting transfer data

Key Factors impacting Method Transfer

  • Exploring key process steps that are site dependent
  • Understanding method capabilities to set acceptance criteria
  • Investigating method transfer failures

Course Locations

Date

TBA

Check-in opens at 7:30 a.m. on the day of the course.

Course runs from 8:30 a.m. to 5:00 p.m.

Register Online Register Via Mail

Venue

TBA


Pricing
  Member Non-Member
Advanced $795 $995
Standard $1,095 $1,295

The course fee includes a course binder and a continental breakfast each day.

Five for Four! Register five people for one course, one person for five courses, or any combination in between and your fifth registration is free. Note: This discount is only available if you register by fax or mail and mention this discount. May not be combined with any other offer.

About the Instructor

  • Kim Huynh-Ba

    has almost 28 years of experience in GMPs, analytical development and stability sciences in Pharmaceutical Industry.