Course offering number:0904-706
Course ID:
2287
Strategies for Leveraging PAT/QbD in Biologic Applications
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Who Should Attend
This course is intended to help biologic and biosimilar professionals charged with enhancing and improving manufacturing efficiency for
existing drug products (PAT) and those who are developing new drugs according to USFDA and EMEA product life cycle initiatives (QbD).
The concepts presented in this course can establish a blueprint for QRM team formation, cost vs. benefit decision tools and guidance
toward the most effective unit operations for PAT/QbD enhancement. It is intended for:
• PAT/QbD Program team members
• Tech transfer personnel
• Purification, separation, pooling and yield staff
• Quality program managers
• Operations and process control personnel
• Production managers
• Fill & finish staff
• Product financial planners
• Function cross-over personnel
• New product planners and developers
• In-process analysts
• Product release analysts
Description
This 90-minute accredited training course provides critical decision-making tools, from inoculation and transfer issues through predictive
operation control to product release, fill and finish -and patient use. The three modules include an overall exploration of the current QRM
climate, benchmarking tools, strategies for technology transfer and smooth regulatory interaction.
Module 1:
• Quality Risk Management embraces both PAT and QbD
• Product and process optimization
• Identifying CQA's and CPP's
• Benchmarking with risk assessment tools
Module 2:
• Using batch history in process optimization
• Inferential and first-order analyzers
• The value of factorial and multivariate analysis
• RPN and documenting: the seeds of technology transfer
Module 3:
• Managing the program
• Training operators: a case for hands-on OJT
• Taking the next steps: PAT leads to QbD, both lead to
SPC and EVOP
• Interfacing with the regulators and regulations
Question and Answer Session