2013 Tampa Training, December 2014


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:

Cleaning Validation Principles (T17) - Updated
Instructor: Becky 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.

Applying Quality Risk Management (QRM) (T42) Computer Mouse Indicates Webinar Included
Instructor: Mike Porter

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.

Risk Based Approach to GxP Process Control Systems: Applying the GAMP® Good Practice Guide (T21)
Instructor: Mike Byrd

This new, highly interactive, course describes how the GAMP Good Practice Guide: A Risk Based Approach to GxP Process Control Systems, may be applied to achieve process control systems that are fit for intended use and meet current regulatory requirements.

Practical Implementation of Process Validation Lifecycle Approach (T46) - New Course
Instructor: Yanhui Hu

This course is relevant to individuals involved throughout the product lifecycle in validation of products and processes, in establishing and implementing Process Performance, Product Quality Monitoring, and Change Management systems in all sectors of the pharmaceutical industry – small and large molecules, innovators, generics, and lifecycle management.

Q7A: Implementing Good Manufacturing Practices (T30)
Instructor: Jack Chu

This course will cover areas in which compliance requirements differ most from traditional pharmaceuticals and biologics, and will review common deficiencies and problem areas related to Q7A.

Auditing for GMPs (G07)
Instructor: Azita Nejad

This course is specifically designed to address the challenges of GMP auditing for the pharmaceutical industry and present the basic competencies required to effectively perform the auditor's assigned responsibilities and contribute to the improvement of auditor performance within a regulated industry.

Managing the Risk of Cross Contamination: Applying the Risk-MaPP Baseline® Guide (T41) - Updated Computer Mouse Indicates Webinar Included
Instructor: Stephanie Wilkins

This course will focus on using the logic diagram, how health based limits are developed, setting cleaning validation limits, risk assessments for cross contamination and formulating a Quality Risk Management Plan as part of a Quality System.

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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