Current Courses Available

Courses

Session 1: Introduction: What is the enhanced approach and how does it differ and compare to the traditional approach?

New Webinar Series on the Enhanced Approach to Analytical Procedures

Session 1

Date: Tuesday June 14th, 2022                  9.00am to 11.00 am Eastern Standard Time

The simple answer is that the Traditional Approach refers to what we have been doing for years. The enhanced approach considers and integrates the key concepts and strategies of QbD and Lifecycle management.
There are significant differences in the two approaches. One of the major ones is that the enhanced approach requires a different mindset and requires a shift of focus onto the quality of the data generated by the procedure rather than being on the procedure itself. Although it requires more work upfront, the enhanced approach results in more robust methods throughout their period of use.Join us for this 2- hour webinar to learn more.

Course Date Jun-14, 2022 9:00 am
Course End Date Jun-14, 2022 11:00 am
Cut off date Jun-13, 2022 12:00 pm
Individual Price CDN225.00
Course Leader Dr. Pauline L McGregor CChemMRSC
CDN225.00 100
Session 2: About the Analytical Target Profile (ATP)

New Webinar Series on the Enhanced Approach to Analytical Procedures

Session 2: About the Analytical Target Profile (ATP)

Date: Wednesday June 15th, 2022                  9.00am to 10.30 am Eastern Standard Time

The analytical target profile is the subject of many heated, yet great disussions. Although the newly published documents for public comments (ICH2 and ICHQ14) do not make this mandatory, defining an ATP can help greatly in driving development of an analytical procedure to ensure only value added experiments are performed, relating to the intended use of the procedure and product requiremnts. It also provides consistent requirments against which the procedure must perform over its lifecycle. For example the performance of the method is considered fit for purpose if it generates data that meets the ATP requirements in the validation exercise and during ongoing verification of the procedure when in routine use.   Join us for this  1.5 hour webinar to learn more.

Course Date Jun-15, 2022 9:00 am
Course End Date Jun-15, 2022 10:30 am
Cut off date Jun-14, 2022 12:00 pm
Individual Price CDN175.00
Course Leader Dr. Pauline L McGregor CChemMRSC
CDN175.00 100
Session 3:The Risk Management Process

New Webinar Series on the Enhanced Approach to Analytical Procedures

Session 3: The Risk Management Process

Date: Thursday June 16th, 2022                  9.00am to 10.30 am Eastern Standard Time

Risk Management is an essential tool to have in your toolbox in the modern pharmaceutical industry. It can be applied to any process and provides benefits of understanding variables, potential failures and mitigating and controlling risk. Two of the key enablers of any risk management process are knowledge gathering and communication. This webinar is based on ICHQ9 and provides an overview of the risk management process,  with the focus on how it is used in the enhanced approach for analytical procedures. If you are not familiar with how to perform risk management, then this is webinar recommended prior to taking further sessions in this series, as they assume knowledge of the risk management process. 

Course Date Jun-16, 2022 9:00 am
Course End Date Jun-16, 2022 10:30 am
Cut off date Jun-15, 2022 12:00 pm
Individual Price CDN175.00
Course Leader Dr. Pauline L McGregor CChemMRSC
CDN175.00 100
Session 4:Quality by Design for Instruments Prior to Transfer of an Analytical Procedure

New Webinar Series on the Enhanced Approach to Analytical Procedures

Session 4: Quality by Design for Instruments Prior to Transfer of an Analytical Procedure

Date: Thursday June 21st, 2022                  9.00am to 10.30 am Eastern Standard Time

As mentioned earlier, once you have the hang of it, Quality by design principles can be applied to any process. This 1.5-hour webinar illustrates how to apply these principles to instruments as a proactive exercise to eliminate/control differences between LC instruments. This is a particularly helpful exercise to perform as part of a gap analysis, prior to any transfer of a validated procedure to a different instrument or laboratory. By going through this process, if problems are still encountered during method transfer, the end user can be reassured that it is not due to instrument differences and can then focus on value added activities to troubleshoot other areas of the analytical procedure.

Join us for this 1.5-hour webinar to learn how to gain a better understanding of your instrument and use this knowledge to mitigate the risk of instrument differences contributing to failure of method transfers. 

Course Date Jun-21, 2022 9:00 am
Course End Date Jun-21, 2022 10:30 am
Cut off date Jun-20, 2022 12:00 pm
Individual Price CDN175.00
Course Leader Dr. Pauline L McGregor CChemMRSC
CDN175.00 100
Session 5: Application of key Quality by Design principles (Enhanced approach Stage 1)

New Webinar Series on the Enhanced Approach to Analytical Procedures

Session 4

Date: Wednesday June 22nd, 2022                  9.00am to Noon Eastern Standard Time

QbD principles and tools presented in this webinar are invaluable during method development or preparing an analytical procedure for transfer or verification. The key to a robust procedure performance over its lifecycle is understanding its intended use and controlling variables that may impact the quality of the data generated by the procedure.

The objectives of this stage of the process is to design and develop a control strategy for the procedure to ensure it will produce quality results that consistently meets the requirements of the ATP through method design, knowledge gathering and understanding of variables.

Course Date Jun-22, 2022 9:00 am
Course End Date Jun-22, 2022 12:00 pm
Cut off date Jun-21, 2022 12:00 pm
Individual Price CDN325.00
Course Leader Dr. Pauline L McGregor CChemMRSC
CDN325.00 100
Session 6: Analytical Procedures: Qualification, Monitoring and Changes (Stage 2 and 3 lifecycle approach)

New Webinar Series on the Enhanced Approach to Analytical Procedures

Session 6

Date: Thursday June 23rd, 2022                  9.00am to11.00am Eastern Standard Time

Qualification of the procedure, is typically referred to as stage 2 of the lifecycle approach to analytical procedures. It resembles the traditional validation; however it is based on a reliable procedure already developed (or assessed in in the case of transfer or verification). It can also be used to confirm replicates for routine analysis and can require knowledge of statistics. The success of the procedure is concluded based on its ability to meet ATP requirements having followed valid statistical design for its intended purpose.

On the successful completion of the qualification step, the analytical procedure is released for routine use ,where it is then monitored continually to provide evidence of its satisfactory performance for its intended use.

This 2 hour webinar discusses the principles of stages 2 and 3 of the lifecycle approach for analytical procedures and provides examples of the qualification process for a newly developed procedure and what this process would look like for verification of a compendial procedure. Examples are also provided for Stage 3 (monitoring of analytical procedure performance). Handling changes to product, testing requirements or the analytical procedure are also discussed.

Course Date Jun-23, 2022 9:00 am
Course End Date Jun-23, 2022 11:00 am
Cut off date Jun-22, 2022 12:00 pm
Individual Price CDN245.00
Course Leader Dr. Pauline L McGregor CChemMRSC
CDN245.00 100