Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality and meet regulatory requirements.
This highly interactive classroom course describes how the GAMP® Good Practice Guide: A Risk Based Approach to GxP Process Control Systems, and GAMP® RDI Good Practice Guide: Data Integrity - Manufacturing Records may be applied to achieve process control systems that are fit for intended use and meet current regulatory requirements. The course covers recommended good practice based on a lifecycle approach for the development and management of process control systems and shows how the principles and concepts of GAMP® 5 may be practically applied to process control systems. It looks at the data created by the process control system through the data lifecycle to understand how to protect against threats to data integrity. The course covers both regulated company and supplier quality management systems and the full system life cycle from concept to retirement.
Karen Ashworth, Director, Karen Ashworth Consulting has 23 years experience in the pharmaceutical industry, initially with a control system supplier and then as a validation consultant. Prior to that, she has experience as both a control systems designer and an operations manager within the nuclear industry. As a consultant, Ashworth has worked on control system projects for over 30 different end users and has experience using GAMP techniques over the full range of projects from small data monitoring systems through to large DCS systems and embedded control systems for complex machines.
Hilary is the European Quality and Validation Manager for Emerson Automation Solutions where she oversees all Life Science projects being supplied with Syncade or DeltaV from a Quality and Validation stance. She is a member of the ISPE Special Interest Group for Process Control Systems, and co-lead the update of the PCS guide following the publication of GAMP5.
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 course is designed to help participants understand the GMPs as they relate to the pharmaceutical industry. Participants will gather information about both European regulators and the FDA, how the various agencies enforce GMP requirements, and what to expect during a routine GMP inspection. They will examine and discuss the process of a regulatory inspection and gain valuable insight into the compliance auditing process.
Monica Koenig Caphart is an experienced former regulator with +30 years of experience at the US Food & Drug Administration (FDA). Her FDA work experience includes positions with responsibilities in strategic and organizational planning, senior-staff supervision, regulatory program leadership, training and education in support of programs to protect public health. Her FDA career includes positions in FDA’s regulatory laboratories, CDER’s Office of Compliance, Division of Manufacturing and Product Quality (technical/regulatory specialist on pharmaceutical laboratory cGMPs), and ORA’s Division of Field Investigations, Office of Medical Products and Tobacco Operations and Office of Training Education and Development.
Carmelo Rosa has a B.S., M.S., Psy.D. His background is in biology and chemistry and holds a doctoral degree as a Clinical Psychologist. He has been with FDA for over 27 years. In May 1990, he started as an Investigator for the Los Angeles district, transferred to Puerto Rico, where he worked for approximately 18 years as a pharmaceutical drug Investigator, Compliance Officer, and member of the FDA foreign drug inspection cadre. He conducted inspections of complex pharmaceutical inspections of sterile, solid dosage, and APIs, as well as other commodities regulated by FDA.
This classroom course uses the second edition of the ISPE Baseline® Guide: Sterile Product Manufacturing Facilities and the FDA's Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice to provide an understanding of the key requirements and GMPs for sterile manufacturing facilities. The Guide provides valuable information on design, while the USFDA's Guidance helps professionals understand the regulatory context and expectations for sterile drug manufacturing.
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 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.