ISPE CEUs: 2.0
Type: Classroom Training Course
|This course is not currently scheduled, but may be offered at your company site. Please contact ISPE for more information.|
This course is relevant to individuals involved throughout the product lifecycle in validation of products and processes. 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 in preparation for and planning for validation of manufacturing control strategy. Additional content will focus on technical approaches and pharmaceutical quality management processes supported by quality risk management applied to process design, qualification of equipment, and process performance.
With the implementation of ICH Q8, Q9, Q10 and Q11 guidelines, the draft ICH Q12, the US FDA Process Validation guidance, EMA’s Process Validation guideline and Annex 15, there is now a greater need to understand that 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 facilitates innovation and continual improvement using a change management system to support improvements in business efficiency.
Course content focuses on practical application of the lifecycle approach to PV. Application of Quality by Design principles (QbD) help with the Process Design phase of new products, drug substance processes, and legacy products and may yield significant business benefits by reducing operating costs and enabling more efficient manufacturing processes. This will be explained and exemplified. The Ongoing/Continued Process Verification stage can be considered a continuum from the end of process qualification stage until product discontinuation, i.e. FDA PV Stage 3.
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.
Throughout the process validation lifecycle:
Note: This course will not cover formulation development, the regulatory submission processes or detailed engineering designs and associated qualification.
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 wishing to understand the concept of process validation as a lifecycle.
This training course is of particular interest to existing and future members of the ISPE Active Pharmaceutical Ingredients, Commissioning and Qualification, Critical Utilities, Oral Solid Dosage, Process Analytical Technology, Product and Process Development, 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.