Training Courses are two-day events that are a great place for your employees to work interactively with industry experts and peers to gain valuable skills and knowledge. Our instructors work in the industry and face the same daily challenges you do. Training Courses are:
This course has been substantially updated to feature the guiding principles of the newly released ISPE Baseline Guide: Water and Steam Systems (Second Edition) with particular emphasis placed upon the new chapters for microbial control and laboratory water as well as key design philosophies.
Auditing is a critical function within a pharmaceutical company. It provides management with information about how effectively the company controls the quality of their processes and products. Auditors must perform their jobs competently to ensure their company’s compliance with pharmaceutical USFDA GMP regulations and other quality standards like ICH Q10.
Using case studies and exercises this course in facility design provides an overview of the concepts utilized in the development and renovation of sound designs for facilities that manufacture biopharmaceutical products.
Risk Based Verification of Facilities, Systems &
Equipment (T48) - New Course
Instructor: Dan Franklin
Through interactive workshops participants will more fully understand and apply the principles of ASTM E 2500-07 and ICH documents (Q8 (R2), Q9, and Q10) to the documented verification that pharmaceutical and biopharmaceutical facilities, systems and equipment that are suitable for their intended purpose.
The course shows how appropriate quality risk management and specification and verification activities should be an integral part of the normal system life cycle. Many suppliers of systems now have mature quality management systems and system development, test, and support documentation. The course promotes the leveraging of supplier documentation and activities to avoid unnecessary duplication, cost and waste.
This course aims to deliver more than the usual project basics and will develop the concept of the project lifecycle from initiation through to delivery of business benefits, providing tools to manage all project resources.
Regulators expect that Quality Risk Management (QRM) is inherently built into the backbone of the Quality Management System (QMS) by using both formal and informal risk tools based on ICHQ9, however, the application and the complexity of the tools needs to be appropriate to the timing of the risk event, the level of risk and the elements of the QMS under scrutiny.
This course will explore the essential concepts and principles of specification, design, commissioning / qualification of equipment and systems used to store and distribute water in pharmaceutical manufacturing.
This course includes a pre-recorded Webinar that provides a review of the basics prior to the classroom course.
ISPE will provide continuing education units (ISPE CEUs) for all North American courses. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be sent via email within four weeks of evaluation materials.