2013 Barcelona Training, September 2014

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Education Details

Training Courses 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:

Science and Risk Based Commissioning and Qualification (T40)
Instructor: Lynn Bryan

Through interactive workshops, this course will explain and apply the science and risk-based approach to verification of systems, equipment and facilities in accordance with the ICH documents Q8 (R2), Q9, and Q10 and ASTM E2500.

Facility Project Management in the Regulated Pharmaceutical Environment (T26)
Instructor: Trish Melton

This course will cover elements of a cleaning validation program from start to finish, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in various pharmaceutical and biotechnology processes, and establishment of scientific rationales acceptable to regulatory inspectors.

Risk Based Approach to GxP Process Control Systems Applying the GAMP® Good Practice Guide (T21) 
Instructor: Hilary Mills-Baker

The course covers recommended good practice based on a life cycle approach for the development and management of process control systems and shows how the principles and concepts of GAMP® 5 may be practically applied to process control systems.

Facility Project Management in the Regulated Pharmaceutical Environment (T42)
Instructor: Alice Redmond

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.

Sterile Product Manufacturing Facilities: Applying the new ISPE Baseline® Guide and FDA Guidance Principles to Design and Operation
Instructor: Gordon Farquharson

This course provides an understanding of the key requirements and GMPs for sterile manufacturing facilities.

Technology Transfer (T19) - New Course
Instructor: Bruce Davis

This course identifies criteria for successful Technology Transfer and provides ‘how to’ examples which can be individually tailored, depending on the type and scope of transfer. It takes into account current industry challenges and real-world examples as tools for industry and regulators to use when conducting and evaluating technology transfer activities.

This indicates that the course includes a pre-recorded Webinar that provides a review of the basics prior to the classroom course.

Continuing Education Units (CEUs)

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.

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