Brussels Training, 5-8 May 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: Rob Walker

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.

Process Validation Lifecycle-Integration to the Pharmaceutical Quality System (T46) - New Course 
Instructor: Line Lundsberg-Neilsen PhD

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.

Basic Principles of Computerized Systems Compliance using GAMP®5, Including Revised Annex 11 and Part 11 Update (T45)
Instructor: Sion Wyn

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.

Control for Critical Environments: HVAC Design Concepts (T14) - New Course
Instructor: Gordon Farquharson

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

Risk Based Verification of Facilities, Systems & Equipment (T48) - New Course
Instructor: Dan Franklin

Through interactive workshops participants will more fully understand and apply the principles of ASTM E250007 and ICH documents (Q8 (R2), Q9, and Q10) to the documented verification that pharmaceutical and biopharmaceutical facilities, systems and equipment that are suitable for their intended purpose.

Managing the Risk of Cross Contamination: Applying the Risk-MaPP Baseline® Guide (T41) - Updated
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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