2013 Raleigh Training, November 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:

Pharmaceutical Water Generation (T04) - Updated 
Instructor: Gary Zoccolante

Participants will examine methods for proper water quality selection, information on compendial and non-compendial waters, fundamentals of basic water chemistry, and information on common unit operations (deionization, reverse osmosis, and distillation). Pre-treatment systems, detailed guidance for selection of construction materials, and operations issues related to pharmaceutical water generation systems will also be discussed.

Process Validation in Biotechnology Manufacturing (T32) 
Instructor: Mark Witcher

This course is designed to provide a clear understanding of the regulatory, scientific, and engineering tools required to successfully develop and validate bioprocesses. In addition, the course identifies the long list of activities required to validate biopharmaceutical processes.

Clinical Trial Materials: Applying Production, Quality Assurance and Packaging Processes (T13)
Instructor: David Glynn

In this course, you will receive a thorough overview of the clinical supply chain from beginning to end, including: designing appropriate packaging and labeling to match the study design, creating a plan of action to prepare the CTM and how to implement the plan and troubleshoot. The course will also cover the logistics of distribution of the CTM to the clinical sites globally.

Control for Critical Environments: HVAC Design Concepts (T14) - New Course
Instructor: Norm Goldschmidt

This course provides insight into the theoretical basis and practical application of environmental control for Pharmaceutical, Biotechnology, Vaccine, Medical Device and Combination Device companies.

Practical Application of Computerized Systems Compliance: Applying the GAMP® 5 Guide: A Risk Based Approach to Compliant GxP Computerized Systems (T11)
Instructor: Jim John

This highly interactive workshop gives participants hands-on experience in applying practical techniques and solutions to solve computerized systems compliance challenges. Participants will discuss and analyze case studies, apply newly acquired knowledge to hypothetical case-study systems, and have the opportunity to discuss their own real-life challenges with other participants and an expert trainer.

Facility Project Management in the Regulated Pharmaceutical Environment (T26)
Instructor: Jeff Odum

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.

Storage, Delivery & Qualification of Pharmaceutical Waters (T23) - Updated
Instructor: Gary Zoccolante

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. The 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, laboratory water and rouging.

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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