Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality and meet regulatory requirements.
Join us as we take a deep dive into critical areas of pharmaceutical manufacturing at the ISPE Bethesda Training Facility located at 6110 Executive Blvd, Suite 600, North Bethesda, MD 20852.
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.
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. He served on several global Novartis teams dealing with computer systems compliance issues and authored many of the firm's global GxP compliance policies. During his 32-year tenure at Novartis, he developed a broad range of experience. He was part of the core team that led the development of GAMP® 5, published in 2008. In addition, he initiated and led the Global Information Systems SIG, who wrote a GAMP® Good Practice Guide that was published in 2005, and he led the team that developed the second edition of this guide that was published in 2017. He was the lead author of the 2014 GAMP® GPG “A Risk-Based Approach to Regulated Mobile Apps,” and was part of the core author team for the 2017 “ISPE/GAMP Guide to Record and Data Integrity.”
As cleaning technology and detection methodology advance, so do the challenges associated with establishing, managing, and maintaining a scientifically sound cleaning validation program. With the FDA's risk-based regulatory initiatives focusing new attention on the risks of cross-contamination understanding lifecycle management techniques for an effective cleaning validation program is paramount. This course covers the risk-based approach to cleaning development and verification; risk analysis; procedures and evaluation tools including FMEA / FMECA, master planning, risk control, PAT, periodic assessment and monitoring, risk review and communication.
Rebecca Brewer has more than 29 years of experience in validation and compliance within the pharmaceutical, biopharmaceutical and medical device industries. She began work with Quality Executive Partners, a boutique consultancy to make a difference in pharmaceutical consulting in 2013. Prior to working with Quality Executive Partners, Becky was Director of Consultancy and GMP Compliance with Dober, where she assisted customers with challenging validation and compliance problems, including Cleaning Validation. Becky has had the opportunity to audit, develop and provide training in validation and compliance programs for a large variety of companies and products. She is the current instructor for ISPE’s Cleaning Validation Educational course and PDA’s Biotechnology Cleaning Validation course. She also frequently conducts site-specific validation and GMP compliance training for individual companies.
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.
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. In her last role Ms. Cappucci was responsible for developing and implementing Bayer’s global standards for computerized systems compliance. She is a past member of the ISPE International Board of Directors, Chair of the GAMP Council, member of the GAMP America Steering Committee and the GAMP Editorial Board.
The successful delivery of manufacturing facilities regulated by various authorities, poses significant challenges to manufacturers, engineering professionals, and equipment suppliers. This interactive classroom course will provide the learner with tools on how to implement a sustainable approach to a risk-based C&Q program, integrate the new C&Q program into existing quality systems, Quality Assurance and Engineering Management Systems and define organizational capabilities to support the new C&Q program. Through interactive workshops, participants will more fully understand and apply the principles of ASTM E2500-07 and ICH documents (Q8 (R2), Q9, and Q10)to the documented verification of pharmaceutical and biopharmaceutical facilities, systems and equipment that are suitable for their intended purpose. Templates will be developed to facilitate the translation of the scientific knowledge about the product and process into documented specification, design, and verification of facilities, systems, and equipment.
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. He holds a BSME from Rensselaer Polytechnic Institute, is an active Member of PDA and has participated on a Technical Report draft team, and an active Member of ISPE. He served on the ISPE board of directors beginning in 1982, and was chairman of the board in 1991. Wisniewski served four years as chairman of the ISPE Community of Practice for Commissioning and Qualification, and was on the ISPE task team that developed the ASTM E2500 Verification Standard.
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.