2013 Prague October Training2013 Prague October Training2013 Prague October Training

Education Details

7 – 8 October

An Overview of Biopharmaceutical Manufacturing Processes (T24) Course includes webinar
Instructor: Bruce Williams, MEng, CEng, FIChemE, Director, Williams Process Limited

This course provides you with an analysis of the relationships between product, process and facility attributes, and identifies current regulatory guidance impacting process development and execution. You will compare various process aspects of upstream and downstream operations and review the options available for single-use technologies in biomanufacturing.

Cleaning Validation Principles (T17)
Instructor: Robert Walker, Director, Rob Walker GMP Consultancy Ltd

This course will cover elements of a cleaning validation programme 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.

GAMP® 5 Process Control Systems (T21) 
Instructor: Hilary Mills-Baker, Principal, Rhombus Engineering Ltd and Karen Ashworth, Director, Karen Ashworth Consulting Ltd 

This course uses discussions and exercises to explain how the risk-based approach can be employed throughout the system lifecycle to efficiently ensure compliant computer systems. The course incorporates generating accurate and complete user requirements with an early emphasis on product and process understanding. It also covers effective collaboration between regulated companies and suppliers.

Sterile Product Manufacturing Facilities (T12) 
Instructor: Bruce Davis, Principal, Global Consulting

This course uses the ISPE Baseline® Guide: Sterile Product Manufacturing Facilities and the FDA's newly published Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice, to cover regulatory philosophy, aseptic process and equipment considerations, clean room design and operation, differential pressure requirements, airlocks, basic utility systems, European HVAC considerations, and a brief introduction to barrier isolation technology.

Turning QbD into a Practical Reality (T43)Mouse Icon
Instructor: Line Lundsberg-Nielsen, Ph.D., Senior Consultant, NNE Pharmaplan

Using exercises the course will delve into implementation and operation of an effective and efficient control strategy in manufacturing which is a key element of process performance and product quality monitoring and continual improvement.

7 – 9 October

Basic GAMP® 5, Including Revised Annex 11 and Part 11 Update (T45)
Instructor: Sion Wyn, Director, Conformity, Ltd.

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

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Recorded Webinars

Mouse Icon 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 European 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.


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 programme.

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