|This course is not currently scheduled, but may be offered at your company site. Please contact ISPE for more information.|
Substantial business benefits are emerging from industry when Quality by Design (QbD) principles are used for new and existing drug products yielding reduced operating costs, enabling significantly more efficient manufacturing processes and better positioning companies to meet increasing regulatory expectations.
For example, the completion of ICH Guidelines, Q8 (R2): Pharmaceutical Development, Q9: Quality Risk Management and Q10: Pharmaceutical Quality System and the recent USFDA guidance on Process Validation contain recommendations for building and capturing process knowledge and understanding and establishing a strategy for process control during Stage 1, process design. There is evidence from 483s and warning letters that FDA is citing unacceptable levels of process understanding, like an unidentified and lack of control of factors that cause variability in process. Additionally, FDA appears to be accelerating the QbD push, suggesting that ANDAs for generic drugs should have QbD elements from 2013 onward. Regulatory expectations are increasing.
This interactive training course utilizes the ISPE PQLI Guide Series: Part 1 - Product Realization using Quality by Design, Concepts and Principles and Part 2 - Product Realization using Quality by Design, Illustrative Example as the basis for explaining and providing examples of how products and processes can be developed, using QbD with special emphasis on the considerations for implementing these processes in manufacturing.
Through group exercises, the course will delve into implementation and operation of an effective and efficient control strategy in manufacturing which is a key element of process performance and product quality monitoring and continual improvement. The link to control of attributes and parameters to relevant critical quality attributes of the product and application and implementation of enhanced, QbD approaches and USFDA Process Validation Guidance will be explored.
Note: This course will not cover the regulatory submission processes or detailed engineering designs.
Immediately apply the course learning objectives through group exercises using the complimentary copies of the ISPE PQLI Guide Series: Part 1 – Product Realization using Quality by Design (QbD): Concepts and Principles and Part 2 – Product Realization using Quality by Design (QbD): Illustrative Example. Mini-regulation handbooks for ICH Q8 (R2), Q9 and Q10 and Q11 will be provided.
We recommend participants complete the primer course webinar, PQLI 101 that provides the background for the origins of the ICH guidelines, Q8 (R2), Q9, Q10 and Q11: Development and manufacture of drug substances (chemical entities and biotechnological/biological entities) and understand the link between these and other relevant regulatory guidelines and the ISPE PQLI Guides. You will receive information via email on how to access the webinar one week prior to the start of the training event.
Within the manufacturing environment:
Manufacturing, engineering, quality and validation professionals with intermediate level experience in manufacturing, engineering, validation, quality control and assurance, technology transfer and those that are new to Quality by Design principles.
This training course is of particular interest to existing and future members of the ISPE API, C&Q, CU, OSD, PAT, PPD, Sterile Communities of Practice (COPs).
ISPE will provide continuing education units (ISPE CEUs) for all North American and European courses. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be available for download in your ISPE account within four weeks of the completion of training. Instruction for download will be sent when the CEUs are available. One hour of education programming equals 0.1 ISPE CEU credits.