Course offering number:0903-706
Course ID:
2126
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Selecting a Drug Product Candidate Using Quality Risk Management: PAT & QbD
In Conjunction with Wiley-Blackwell
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Who Should Attend
This course is intended to help pharmaceutical industry 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,
experimental and monitoring tools and wide aspects of applicable drug formulation and dosage forms. It is intended for:
• PAT & QbD team managers
• Tech transfer personnel
• Formulators
• Quality program managers
• New product developers
• Production managers
• Regulatory affairs personnel
• Product financial planners
• Function cross-over personnel
• PAT & QbD team members
• In-process analysts
• Product release analysts
Description
This 90-minute accredited training course provides critical decision-making tools, from dosage form design through predictive
operation control to product release and patient use. The three modules include an overall exploration of the current QRM
climate, benchmarking tools, selection strategies for new and mature drugs and smooth regulatory interaction.
Module 1:
• Product optimization and life cycle
• Quality Risk Management embraces PAT and QbD
• Birth and death processes of a drug candidate
• Corporate vs. QRM implementers' benchmarks
Module 2:
• Using batch history in the decision process
• Identifying CQA's and CPP's
• Selecting a mature drug product
• Selecting a developmental drug product
Module 3:
• Comparing conventional and QRM life cycles
• Tools for parsing the drug product operation
• Factorial decision-making for product characteristics
• Drug substance influence on the drug product and dosage
form
Question and Answer Session