Deep Dive into Pharma Training Courses 

Join us after the 2019 ISPE Annual Meeting & Expo as we take a deeper dive into critical areas of pharmaceutical manufacturing. 

Basic Principles of Computerized Systems Compliance using GAMP® 5, Including Revised Annex 11 and Part 11 - Update!

31 Oct – 1 Nov 2019

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 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.

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Arthur D. Perez, PhD
Retired Director Information Governance and Management
Novartis Pharmaceuticals

Dr. Perez retired at the end of 2015 from the position of Director, Information Governance and Management for Novartis Pharmaceuticals. His responsibilities at Novartis included a wide range of IT Compliance issues, such as GxP, Sarbanes-Oxley, and data privacy. 

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)

31 Oct – 1 Nov 2019

This highly interactive classroom 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. 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.

The course covers both regulated company and supplier quality management systems and the full system life cycle from concept to retirement. This course shows how appropriate quality risk management and specification and verification activities should be an integral part of the normal system life cycle. Many suppliers of systems now have mature quality management systems and system development, test, and support documentation. The course promotes the leveraging of supplier documentation and activities to avoid unnecessary duplication, cost and waste.

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Mr. Michael Byrd
Dir Computer System Validation
ProPharma Group

Mike Byrd, the Director of Computer System Validation (CSV) for ProPharma Group has over 25 years in the pharmaceutical and biotechnology industries, and over 30 years of information systems experience. 

Efficient, Effective Pharma Manufacturing Problem Solving Through the Use of Engineering First Principles

31 Oct – 1 Nov 2019

The implementation of Quality by Design (QbD) and Six Sigma within the pharmaceutical industry has led to an emphasis on the importance of companies developing a robust operational control strategy (OCS) to drive the management of product manufacturing processes. This course will show how First Principles-based approaches will provide a valuable tool to help create such control strategies. Drawing on examples from over 30 years’ experience in the pharma industry, the attendees will see what First Principles are and how not using a First Principle approach can lead to poor problem solving and even significant disasters. Many activities and exercises will be used to demonstrate the application of First Principles to problem-solving in pharmaceutical manufacturing and engineering. A detailed process for implementing the First Principle approach will be presented, including an example of a complete application of this process.

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Bernard M. McGarvey, Ph.D. Chem. Eng.
Engineering Fellow (Retired)

Bernard McGarvey Ph. D., retired as an engineering fellow at Eli Lilly and Company at the end of 2017. He has a B.E. and Ph.D. in Chemical Engineering from University College Dublin, Ireland. He spent 34 years working for Eli Lilly and Company at various locations in Ireland and the USA.