Analytical procedure transfer happens often. Using the approaches taught in this course the transfers will be a happy experience more often. The transfer occurs from the development laboratory to the Quality Control (QC) laboratory; from one QC laboratory to another; from one company to another company. No matter the laboratories involved, basing the transfer on the lifecycle approach for an analytical procedure and using analytical quality by design (aQbD) provides tools that can make the transfer efficient and effective.
The transfer starts with documented knowledge gathering, part of knowledge management. This includes a thorough and complete understanding of the intended use of the analytical procedure. A decision rule can be used to arrive at this understanding. Next the target measurement uncertainty is determined, if it is not already known. Using this information an analytical target profile (ATP) is created or confirmed. These provide the acceptance criteria for the success of the transfer and it is all based on fitness for intended use. The transfer protocol is written identifying the required experiments, with the rationale and justification for each experiment that comes from risk analysis. The statistical tools, such as tolerance interval, will be presented. The experiments are conducted. Using the planned statistical tools and knowledge, the data from the experiments is assessed. Finally, the control strategy for the analytical procedure in the receiving laboratory is confirmed and implemented.
The course will present these steps using examples with opportunity for questions and discussions. Bring your analytical procedure transfer challenges and learn how to tackle them with the lifecycle approach.
The course will introduce the lifecycle approach to transferring analytical procedures. It will include:
· Analytical target profile (ATP)
· Target measurement uncertainty
· Content for the protocol
· Experimental design examples
· Statistical tools, such as tolerance intervals
· Risk analysis
· Regulatory requirements
SPEAKER: Jane Weitzel
Jane Weitzel has been working in analytical chemistry for over 40 years for pharmaceutical and mining companies. She is currently a consultant specialising in laboratory management systems and ISO/IEC 17025, an auditor, and an educator. Jane has applied Quality Systems and statistical techniques, including the evaluation and use of measurement uncertainty, in a wide variety of technical and scientific businesses. She has obtained the American Society for Quality Certification for both Quality Engineer and Quality Manager.
For the 2010 – 2015 cycle, Jane was a member of the USP Reference Standards committee and Expert Panel on Method Validation and Verification. In 2014 she was pointed to the Chinese National Drug Reference Standards Committee and attended their inaugural meeting in Beijing. Jane is a member of the USP’s Expert Committee on Statistics and the Expert Panel on Method Validation and Verification For the 2015 – 2020 cycle.
|Student Ticket:||$250.00||— Sold Out|
|Non- Member Single Ticket:||$525.00||— Sold Out|
|Non- Member Group Tickets (5+):||$505.00||— Sold Out|
|Pro/Pro Plus Member Single Ticket:||$495.00||— Sold Out|
|Pro/Pro Plus Member Group Tickets (5+):||$475.00||— Sold Out|