Education Details
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.
9-10 December
Pharmaceutical Water Generation (T04) 
Instructor: Gary
V. Zoccolante, Pharmaceutical Technical Director, Siemens Water Technologies Corp.
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.
Cleaning Validation Principles (T17)
Instructor: Rebecca
Brewer, Director of Validation and GMP Compliance, Dober Group
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.
Applying Quality Risk Management (T42)
Instructor: Steven
Wisniewski, Principal Compliance Consultant, Commissioning Agents, Inc.
Through interactive workshops, this course will explain and apply the key principles of QRM programs that need to include Quality Systems elements (ICH Q10) within the product/system lifecycle
9-11 December
Control for Critical Environments: HVAC Design Concepts (T14)
Instructor: Norman Goldschmidt, Principal, Genesis Engineers, Inc.
This course will provide a detailed description of HVAC system fundamentals, including a discussion of primary system components such as fans, coils, humidifiers, and filters.
11-12 December
Clinical Trial Materials (T13)
Instructor: David Glynn, Senior Manager, Clinical Trial Materials Management,
Sunovion Pharmaceuticals Inc.
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.
Storage, Delivery & Qualification of Pharmaceutical Waters
(T23)
Instructor: Gary V. Zoccolante, Pharmaceutical Technical Director, Siemens Water
Technologies Corp.
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.
Science and Risk Based Commissioning & Qualification (T40)
Instructor: Steven Wisniewski, Principal Compliance Consultant, Commissioning
Agents, Inc.
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, Q9, and Q10 and ASTM E-2500.
Maximize your learning experience and complete the course
webinar offered prior to the start of class. Courses include a pre-recorded Webinar reviewing basic
information so you can maximize your learning experience during the course. Access information will be
provided via email one week prior to the start of the training event.
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.
Certified Pharmaceutical Industry Professional™ (CPIP™)
Some courses contain knowledge related to the CPIP™ Technical Knowledge and Competency Elements. For complete information concerning the knowledge elements or the CPIP™ Credential, please visit www.ISPE-PCC.org. The ISPE Professional Certification Commission does not endorse any of these resources, products, or services offered relative to the CPIP™ certification program.
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