Deep Dive into Pharma Training Courses 

Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality and meet regulatory requirements.

  • Real World Practice:  Courses present exercises that use current problems and situations common to the industry.
  • Experienced Instructors:  Subject matter experts and top leaders in the pharmaceutical industry who have years of experience in their field of study.
  • Global Training to Fit Your Needs:  With classroom, eLearning and onsite training options available, ISPE training courses adapt to any schedule or location.   

Basic Principles of Computerized Systems Compliance using GAMP 5, Including Revised Annex 11 and Part 12 - Updated!
2 - 3 April 2020

This 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. GAMP® guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements.

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Sion Wyn
Director
Conformity Ltd.
Instructor

Sion Wyn, Director, Conformity Ltd., is an acknowledged expert in computer system validation and compliance and international regulations in this field. He assisted the FDA as a consultant with its re-examination of 21 CFR Part 11, and was a member of the core team that produced the FDA Guidance on 21 CFR Part 11 Scope and Application.


Applying the Biopharmaceutical Manufacturing Facilities Baseline Guide Principles Updated!
2 - 3 April 2020

This classroom training course in biopharmaceutical manufacturing facility design provides an overview of the concepts utilized in the development and renovation of sound designs for facilities that manufacture biopharmaceutical products.

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Mark S. Von Stwolinski, RA
VP Facility Integration
CRB
Instructor

Mark von Stwolinski is the Vice President of Architectural Services at Clark Richardson & Biskup (CRB) Consulting Engineers. He has over 22 years of experience in the design and construction of biopharmaceutical facilities worldwide. His experience with ISPE guidance documents includes: Steering Committee member and contributing author for five ISPE Guides, Chair and contributing author for the new ISPE Baseline® Guide: Biopharmaceutical Manufacturing Facilities, issued in 2013.


A Risk-based Approach to GxP Process Control Systems: Applying the GAMP Good Practice Guide: A Risk-Based Approach to GxP process Control Systems (2nd Edition) 
2 - 3 April 2020

This GAMP 5 GxP Process Control Training 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.

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Aseptic Processing and Annex 1
2 - 3 April 2020

This 2-day course will focus on aseptic processing and quality management around the most important pharmaceutical technology.

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Jörg Zimmermann
Vice President Vetter Development Service, External Affairs
Vetter Pharma-Fertigung GmbH & Co.
Instructor

Jörg Zimmermann is currently Vice President of Vetter Development Services for Vetter Pharma Fertigung GmbH&Co KG, Ravensburg, Germany. In this role, he is responsible for manufacturing science & process development, technology & process transfers, project & service analytics and drug delivery systems. Within Vetter, Jörg has held various positions in process implementation, new product introduction, lyophilisation process development and as production manager before becoming Director of Production of Vetter's production site at Lake Constance in 2000.

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