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.
Winnie Cappucci retired from the position of Associate Director Product Supply IT Systems Compliance, North America for Bayer HealthCare. She has worked in the pharmaceutical industry for 43 years and in global roles for the last 19 years. Ms. Cappucci has worked as a business process owner, an IT professional and lastly as a quality and compliance specialist in a highly regulated environment.
This GAMP Data Integrity 21 CFR Part 11 Classroom Training Course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data.
Steve Piotrowski is a Principal Consultant with ProPharma Group and has worked with organizations in the areas of pharma / medical device / and healthcare for the past 32 years. Steve’s skillsets range from international project management for implementation of ERP systems to computer systems and equipment validation. Steve is often brought in to client sites to manage and perform risk assessments, audits, and execute gap remediations relative to data integrity compliance.
Science and Risk-based Commissioning and Qualification - Applying the ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification (T40) Overview Through interactive workshops, this course will explain and apply the science and risk-based approach to verification of systems, equipment and facilities in accordance with the ICH documents Q8 (R2), Q9, and Q10 and ASTM E2500. Topics covered include the principles and activities that constitute an efficient and acceptable approach to demonstrating facility and equipment fitness for use as required by major global regulatory authorities; improving the ability to meet documented process requirements; controlling risks within the manufacturing process
Steven Wisniewski is Principal Consultant for CAI Consulting, a highly respected provider of consulting and technical services for biotech and pharmaceutical manufacturers worldwide. CAI Consulting focuses on the manufacturing lifecycle process, with services including commissioning, validation, technology transfer, owner Project Management, maintenance programs, SOPs, training and cGMP compliance. Wisniewski has more than 35 years’ experience in the pharmaceutical, biotech, and device industries.
This classroom course on Pharmaceutical Technology Transfer identifies criteria for successful technology transfer and provides ‘how to’ examples which can be individually tailored, depending on the type and scope of transfer.
Jeff Odum is Principal, NCBiosource located in Raleigh, North Carolina. He has over twenty-five years of management experience in the design, construction, and commissioning of facilities in the process, biotechnology, and pharmaceutical industries. A recognized expert in biopharmaceutical manufacturing, Mr. Odum has authored over seventy articles and four Industry reference books on subjects related to GMP compliance, process improvement, and the design and construction of biopharmaceutical manufacturing facilities. He is a welcomed speaker at numerous international industry forums and conferences, presenting on topics relating to next generation facility design, bioprocess manufacturing, project management and GMP compliance.