|5 - 6 May 2014||Brussels||Belgium||
Line Lundsberg-Nielsen, PhD|
|21 - 22 May 2014||Indianapolis, IN||USA||
Ms. Yanhui Hu, Ph.D.|
|3 - 4 Dec 2014||Tampa, FL||USA||
Ms. Yanhui Hu, Ph.D.
This course is relevant to individuals involved throughout the product lifecycle in validation of products and processes, in establishing and implementing Process Performance, Product Quality Monitoring, and Change Management systems in all sectors of the pharmaceutical industry – small and large molecules, innovators, generics, and lifecycle management. It will help you link the science and risk-based process validation lifecycle approach to the Pharmaceutical Quality System. It will provide you with practical application of quality risk management. Additional content will focus on technical approaches and pharmaceutical quality management processes supported by quality risk management applied to process design, qualification of equipment, utility and process performance.
With the implementation of ICH Q8, Q9, Q10 and Q11 guidelines and the USFDA Process Validation guidance and issue of EMA’s draft Process Validation guideline there is now a greater need to understand the science- and risk-based approach to management of the product lifecycle. For example process validation should be considered a science- and risk-based, life cycle activity rather than a one-time event of manufacture of three commercial scale batches. Companies should demonstrate that processes in the commercial phase of the lifecycle are maintained in a state of control using a science- and risk-based approach. A pharmaceutical quality system as discussed in ICH Q10 facilitates managing the product lifecycle and also facilitates innovation and continual improvement using a change management system to support improvements in business efficiency.
This course links the science- and risk-based process validation lifecycle approach to the Pharmaceutical Quality System. It provides practical application of quality risk management. Additional content will focus on technical approaches and pharmaceutical quality management processes supported by quality risk management applied to 3 phases of the product lifecycle:
This workshop-based course utilizes examples to support discussion for linking science- and risk-based process validation lifecycle approaches and the Pharmaceutical Quality System. Quality risk management is a key enabler: hence principles, tools and techniques will be explained and practiced.
Course content focuses on two key pharmaceutical quality system elements: change management throughout the lifecycle, and establishment and operation of a Process Performance and Product Quality Monitoring System in the continued process verification stage of the lifecycle. Application of Quality by Design principles (QbD) can help with the Process Design phase of new products, drug substance processes, and legacy products and yield significant business benefits by reducing operating costs and enabling more efficient manufacturing processes. This will be explained and exemplified.
The continued process verification stage could be considered a continuum from the end of process qualification stage until product discontinuation. For ease of representation this extended phase could be divided into an initial sub-stage (a) where sufficient data are being generated to produce variability estimates, and a subsequent sub-stage (b) of so called routine operation, where levels of sampling and monitoring may be reduced compared with earlier stages. The lifecycle can be described as follows:
Immediately apply the course learning objectives using the ISPE PQLI® Guide Series: Part 3, Change Management System as a Key Element of a Pharmaceutical Quality System and Part 4, Process Performance and Product Quality Monitoring System. Links to the Guides will be provided prior to the training course.
We recommend participants complete the primer course webinar, Product Quality Lifecycle Implementation® (PQLI®) 101: Vision, Status and Next Steps that provides the background for the origins of the ICH guidelines, Q8 (R2), Q9, Q10 and Q11 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.
Throughout the process validation lifecycle:
Note: This course will not cover formulation development, the regulatory submission processes or detailed engineering designs.
This course is relevant to individuals involved in process validation of products and processes in all sectors of the pharmaceutical industry – small and large molecules, innovators, generics, and lifecycle management. Specific job functions include development, manufacturing, engineering, quality, and validation professionals with intermediate level experience in development, manufacturing, engineering, validation, quality, technology transfer and those that are new to the concept of process validation as a lifecycle.
This training course is of particular interest to existing and future members of the ISPE API, C&Q, CU, OSD, PAT, PPD, and Sterile Communities of Practice (COPs).
ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.
Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. 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 a 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.