Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality and meet regulatory requirements.
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.
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.
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.
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.
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.
This 2-day course will focus on aseptic processing and quality management around the most important pharmaceutical technology.
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.