Join us before the 2019 ISPE Europe Pharma 4.0 as we take a deeper dive into critical areas of pharmaceutical manufacturing.
This Classroom training course has been updated to include the new revised EU GMP Annex 11, and an update on 21 CFR Part 11. This two or 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. GAMP® guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements.
The course does not aim to cover detailed and highly technical aspects of software and hardware engineering, but rather gives the principles and an overview of the overall computer systems compliance process, including a scalable and efficient system lifecycle, Quality Risk Management, GAMP® categories, the role of the supplier, and the selection of appropriate specification and verification activities.
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. He was the technical content expert for the FDA’s ORA Virtual University on-line training modules on computerized systems validation and compliance. He received the FDA Group Recognition Award for work on Part 11. Wyn is the editor of ISPE’s GAMP5 Guide - A Risk-Based Approach to Compliant GxP Computerized Systems, and is a member of the ISPE GAMP Global Steering Committee, GAMP Editorial Board, and the GAMP Europe Steering Committee. He is lead GAMP and Computer Systems Validation and Compliance, Part 11, and Data Integrity trainer and course developer for ISPE. He has extensive experience in all aspects of computer systems validation and compliance.
The Pharmaceutical Quality System (PQS), supported by ICH Q10, is the key foundation on which product realization depend. Through lecture and group exercises this course illustrates how quality systems work, the purpose of the different elements, how they connect to each other and how to recognize and transfer knowledge/connectivity throughout the organization. The diagram below from ICH Q10, covers the product life cycle for a PQS/QMS system and all aspects will be covered by this course. We will be using QMS and PQS terms interchangeably throughout this course to establish a holistic approach.
Bruce Davis, Principal, Global Consulting is a professional engineer, and has many years’ experience in the pharmaceutical industry and a wide international knowledge, and operates a consultancy in QbD, Engineering, Process Validation and reducing Human Error. He is an Associate to NSF-DBA, the training & consultancy Company. He previously worked at AstraZeneca, where he had a number of responsibilities, including managing international engineering, and this extended to provision of sterile facilities. Davis has been a member of ISPE since 1991, and is a member of the United Kingdom Affiliate. He has held the position of Chair of ISPE International Board of Directors and has been active in supporting ISPE, including leading the team writing the original Sterile Baseline® Guide and its current update. He also led ISPE’s case study for practical implementation of Quality by Design (QbD) and is currently co-chairing the team updating ISPE’s Technology Transfer Guide. Davis also facilitated the change to qualification to enable science and risk based principles to be adopted. Previous experience includes the position of past secretary to ASTM E55.03 Committee on General Pharmaceutical Standards and leading the team that set up a distance-learning course, for a UK university, involving some 40 webinars.
Line Lundsberg-Nielsen, PhD is Global Technology Partner in GMP & Regulatory at NNE. Her background is pharmaceutical manufacturing and development. Today she works as a consultant in Science & Risk based approaches, QbD, PAT, Control Strategy, Process Validation and Pharma 4.0. Line has been a member of ISPE for 15+ years and has served many roles. She is currently the co-chair of the global PAT & LCS CoP.
Driven by biopharmaceuticals but also prominent in small molecules drug manufacturing as well as for APIs, aseptic processing will undergo a technology jump start driven by the new EC GMP Guide Annex 1. Globally supplying companies, which deliver drugs to Europe, must comply with this new regulatory requirement. There is an impact for all stakeholders of manufacturing, across hierarchy levels and various functions at manufacturers. Also, suppliers have to consider Annex 1 when supplying new equipment or installing new production facilities. This 2-day course will focus on aseptic processing and quality management around the most important pharmaceutical technology.
Jean Francois has spent more than 20 years in the pharmaceutical industry in various positions: quality control, oral solid dosage forms manufacturing (tablets, capsules), packaging, raw materials production from bacteria growth, industrial development (scaling up, equipment qualification, process validation, cleaning validation), dual compartments syringes aseptic filling.He has seventeen years of experience in pharmaceutical engineering. Jean-François was involved in the conceptual design phases for oral solid dosage forms facilities and in the conceptual design phases for sterile products facilities aseptic filling, freeze drying. He has gained expertise in containment issues for high potent API and production equipment sizing and facility layout design. He was also involved with GMP Design reviews and Regulatory Affairs for most Technip pharmaceutical projects.
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. There he managed 5 production lines for aseptically prefilled injection systems. In September 2010 he became responsible for the process development and process introduction group at Vetter before being promoted to Vice President in November 2014. Jörg has volunteered as track leader and speaker at conferences by ISPE, PDA, and Concept Heidelberg for over 15 years and served as the PDA-representative at the “interested parties meeting” at the EMA on the revision of Annex 1 in 2006. Jörg studied pharmacy in Freiburg, Germany and Cardiff, Wales and is a registered pharmacist.