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Education Details

20-23 May

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, 20-21 May

Pharmaceutical Water Generation (T04) Includes Webinar
Instructor: Gary Zoccolante, Pharmaceutical Technical Director, Siemens Water Technologies Corporation

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.

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.

Monday-Wednesday, 20-22 May

Basic Principles of Computerized Systems Compliance using GAMP5, Including Revised Annex 11 and part 11 Update (T45)
Instructor: Kate Townsend, EMC Consulting

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, 22-23 May

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.

Storage, Delivery & Qualification of Pharmaceutical Waters (T23)
Instructor: Gary Zoccolante, Pharmaceutical Technical Director, Siemens Water Technologies Corporation

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.

Recorded Webinar

Includes Webinar Maximize your learning experience and complete the course webinar offered prior to the start of class. Some 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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