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. Training Courses are:

Monday - Tuesday, 9 - 10 September

Pharmaceutical Water Generation (T04)
Instructor: Andrew Collentro

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

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.

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.

Monday - Wednesday, 9 - 11 September

Control for Critical Environments: HVAC Design Concepts (T14) 
Instructor: Norman Goldschmidt

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.

Basic Principles of Computerized Systems Complinace using GAMP5, Including Revised Annex PArt 11 and part 11 update (T45) 
Instructor: Kate Townsend

This three-day fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements.

Wednesday - Thursday, 11 - 12 September

Oral Solid Dosage Forms(T10) 
Instructor: Jack Chu

The course will begin with a description of the three main OSD processing methods: Direct Compression, Wet Granulation and Dry Granulation. It will continue with a detailed review of all the major unit operations associated with OSD manufacturing processes.

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.

Storage, Delivery & Qualification of Pharmaceutical Waters(T23) 
Instructor: Andrew Collentro

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.

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This 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.

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.