"I can recommend Pauline’s workshop on the lifecycle approach for analytical procedures if you want to learn more about this important topic. If you want to find out more about the future direction of ICHQ2 and the new ICHQ14 guideline on Analytical Development then this is a must!."
Phil Borman Director, Quality by Design Development Lead for Small Molecules at GSK
Enhanced Approach and Lifecycle Management for Analytical Procedures
Course Objectives and Learnings
Benefits/advantages to attending this course are:
o Improve performance of analytical procedures
o Improve understanding of analytical procedures
o Reduce the number of OOS results due to poor method performance
o Increase success of transfer or verification analytical procedures
o Reduce non-value-added activities during investigations, development, verification and transfer
o Improve knowledge transfer and communication
o Keep up to date with best practices and guidelines for analytical procedures
This 2-day technical training course integrates the following principles of QbD and the lifecycle management to analytical procedures into current practices (Development, verification and transfer) to improve and maintain the performance of analytical procedures.
- Knowledge gathering
- The acceptance criteria target profile
- The Analytical Control strategy (identifying and controlling the appropriate method parameters)
- Risk Assessment Tools
- The qualification process
- Monitoring analytical procedures for acceptable performance throughout its lifecycle.
A fun, hands on practical component using a Statapult has been designed to demonstrate setting a target profile, investigating and controlling variables for the procedure and qualifying the procedure against the predetermined target.
Case studies are included for development of a new procedure, a method transfer and a verification of a compendial monograph procedure.
This workshop is based on ICH Q8, Q9, Q10 and Q11 which have been adapted to suit analytical procedures. It also provides an update on the proposed new chapter ICHQ14 (Analytical Procedure Development), proposed updates to ICHQ2 (Analytical Validation).
Although the material is based on HPLC for small molecules, the principles taught and the practical session, may also be applied to analytical procedures for large molecules.
Who should attend?
Chemists or management involved in the testing of pharmaceutical products
Managers, Supervisors, Laboratory Analysts and Associates involved in the development, validation, transfer, testing or review of analytical procedures in the Pharmaceutical and related industries with daily responsibilities in the following areas:
- Analytical Development Laboratory
- Quality Control Laboratory
- Contract Laboratory
- Quality Assurance
What’s included with the workshop?
Each participant will receive:
• A certificate of attendance upon completion of the training course.
• Printed materials and handouts relating to the training course
• Lunch and light refreshments each day.
Pauline McGregor, PhD. CChem MRSC has over 30 years experience in the pharmaceutical industry.
She been involved in the development of this topic since 2010
She is an expert in quality systems and procedures, GMP regulations and analytical chemistry. She brings a technical expertise to laboratories which enable her to assist them to develop, transfer, verify and validate analytical procedures, and also optimize efficiency with regards to laboratory operations and troubleshooting in an analytical development and QC environments.
Pauline has utilized her skill set globally in the UK, Canada, US, Jordan, Brazil and China and has helped companies prepare for a GMP inspection to gain their European/Health Canada/FDA GMP licenses.
Pauline was a member of the USP expert panel for Validation, Verification and Transfer of Analytical Procedures and is currently on a USP Chemical Medicines expert committee. Pauline is also a member of The Royal Society of Chemistry, UK.
|Course Date||Apr-14, 2020 8:45 am|
|Course End Date||Apr-15, 2020 5:00 pm|
|Registration Start Date||Jan 29, 2020|
|Cut off date||Mar 31, 2020|
|Course Leader||Pauline McGregor, P.h.D.CChem MRSC|
|Location||Fairfield Inn & Suites Toronto Airport Hotel|