Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality and meet regulatory requirements.
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. Please click the "Locations and Registrations" table to select the two or three-day sessions.
Mike Byrd, the former 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. Mike has developed, implemented, administered, and validated a wide variety of computer-based solutions supporting critical regulated business processes. He has held numerous individual contributor and management roles in his career, many of which have involved forming and managing cross-functional system project teams.
This classroom course aims to deliver more than the usual project basics and will develop the concept of the project lifecycle from initiation through to delivery of business benefits, providing tools to manage all project resources. It is specifically targeted to the needs of facility projects within the regulated pharmaceutical industry and demonstrates the value inherent in the use of “good practice” project management in the regulated pharmaceutical environment. Trends in regulatory compliance, environmental, health and safety legislation, project delivery methodologies and product speed to market expectations all impact how pharmaceutical facility projects are managed.
William Deckert is the Business Area Leader for OPM (Owner's Project Manager) Services for CAI (Commissioning Agents Inc.) an employee owned consulting firm specializing in helping clients complete their projects in a more timely manner and get their new products to market quicker. He has over 30 years of design/build experience with clean compliant research and manufacturing facilities worldwide. He has managed engineering and construction projects from concept all the way through to validation, with project sizes up to $500mm.
Lifecycle Process Validation (PV) remains one of the most important and commonly misunderstood topics in the pharmaceutical industry. How many lots should I make? Are we taking enough samples? Do we need to use statistics in our protocols? The real question may be: am I even focusing on the right questions? Course participants will focus on the practical application of the lifecycle approach to all stages of PV to gain valuable knowledge and insight on the regulations, guidance, and best practices currently utilized across the industry.
Tara Scherder has over 20 years of experience in the pharmaceutical and biopharmaceutical industries as a statistician, process engineer, and master black belt. She has functioned as both an in-house and external statistical consultant to drug substance and drug product teams across the product lifecycle for the spectrum of product platforms. She frequently speaks at industry forums and publishes on the practical incorporation of statistical methods for Lifecycle Process Validation.
Shawn Gould is Director of Compliance with Johnson & Johnson’s Regulatory Compliance group. He currently holds responsibilities in the Pharma Segment overseeing compliance issues regarding large molecule products as well as serving on Proactive Compliance and PV Lifecycle Implementation teams. Shawn also served in the US Food and Drug Administration’s Office of Compliance where he worked on the pre-approval process for new and generic drugs with special emphasis on applications involving QbD and PAT concepts. He also served on FDA working groups relating to Quality Systems, the PAI process, Strategic Planning, and Lean Operations within the agency.
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.
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.
Christa Myers has been in the pharmaceutical industry for over 25 years. Christa is a well-recognized speaker at conferences and is frequently on-stage teaching others about regulatory requirements, operational issues, and what to expect in the future of the industry. Christa champions approaches that integrate strong project execution and technical solutions. Christa is on the Steering Committee for the ISPE Community of Practice for Sterile Products Processing, a certified ISPE Instructor of the Sterile Product Processing Baseline guide, the 2019 Chair of ISPE’s Women in Pharma group, as well as an author of the most recent ISPE Sterile Processing Baseline Guide.