2019 ISPE Cambridge In-Depth Pharma Training Series

Deep Dive Pharma Training Courses 

Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality and meet regulatory requirements.

  • Real World Practice:  Courses present exercises that use current problems and situations common to the industry.
  • Experienced Instructors:  Subject matter experts and top leaders in the pharmaceutical industry who have years of experience in their field of study.
  • Global Training to Fit Your Needs:  With classroom, eLearning and onsite training options available, ISPE training courses adapt to any schedule or location.   

Cleaning Validation Principles

24-26 Jun 2019

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.

Learn More & Register

Instructor

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. 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.”


An Overview of Biopharmaceutical Manufacturing Processes

24-25 Jun 2019

This course provides a comprehensive understanding of biotech manufacturing processes - what makes biopharmaceutical processes different from small molecules. Course content explores the underlying principles of proteins and cells to provide the foundation for how and why processes manufacture therapeutic proteins.

Learn More & Register

Instructor

Rusty Morrison is an experienced pharmaceutical professional with over 30 consecutive years of experience at all levels in technology transfer, CMC project management, process validation, commissioning, qualification, validation, engineering, and manufacturing. Significant biopharmaceutical experience includes managing a bulk drug substance site-to-site tech transfer; managing early-stage RNA interference CMC activities for multiple products in the development pipeline; multiple assignments managing teams providing risk-based validation, commissioning, and engineering services for mammalian cell culture facilities; and serving as Director of Facilities & Engineering for a startup vaccine manufacturer. Other relevant experience includes leadership of a team responsible for all process validation protocols for the start of commercial operations at one of the largest mammalian cell culture facilities in the U.S.; including protocol generation, execution, deviation resolution, and report preparation.


Pharmaceutical Water Generation

24-25 Jun 2019

This classroom course will cover the principles of design and operation of water systems used directly in pharmaceutical manufacturing and laboratory applications, including the essential concepts and principles of systems used to generate USP and non-compendial waters. These concepts include specification, design, operation, testing, and maintenance of equipment and systems for water generation.

Learn More & Register

Instructor

Gary V. Zoccolante is the Technical Director of Plymouth Rock Water Consultants. He was formerly Pharmaceutical Technical Director for Evoqua Water Technologies. Zoccolante has over 40 years of experience in the design, operation and trouble-shooting of pharmaceutical water systems. He has been involved in the development of equipment for pretreatment, reverse osmosis, deionization, ultrafiltration and distillation. Zoccolante, a member of ISPE since 1992 was a committee member of both the original and updated ISPE Baseline® Water and Steam Systems Guide. He has been part of the Guide Presentation Team on several occasions. He was involved in face-to-face meetings with FDA to help resolve many of the Guide principles.  


Storage, Delivery and Qualification of Pharmaceutical Waters

26-27 Jun 2019

ISPE’s Baseline Guide: Risk-Based Manufacture of Pharmaceutical Products (Second Edition) helps companies manage their risk of cross-contamination by outlining a scientific, risk-based methodology based on ICH Q9 that can be used to lead teams through the process to satisfy auditors as well as global regulators.  This classroom course will focus on using the logic diagram, how cross-contamination control fits into the Quality System, how health-based limits are developed, setting cleaning validation limits, risk assessments for cross contamination and formulation a Quality Risk Management Plan.

Learn More & Register

Instructor

Gary V. Zoccolante is the Technical Director of Plymouth Rock Water Consultants. He was formerly Pharmaceutical Technical Director for Evoqua Water Technologies. Zoccolante has over 40 years of experience in the design, operation and trouble-shooting of pharmaceutical water systems. He has been involved in the development of equipment for pretreatment, reverse osmosis, deionization, ultrafiltration and distillation. Zoccolante, a member of ISPE since 1992 was a committee member of both the original and updated ISPE Baseline® Water and Steam Systems Guide. He has been part of the Guide Presentation Team on several occasions. He was involved in face-to-face meetings with FDA to help resolve many of the Guide principles.  


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)

24-25 Jun 2019

This GAMP 5 GxP Process Control Training 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.

Learn More & Register

Instructor

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. Mike’s educational credentials include a Bachelor of Science in Chemistry and a Master’s in Business Administration with an emphasis in Technology Management. Mike has developed, implemented, administered, and validated a wide variety of computer-based solutions supporting critical regulated business processes. These included systems supporting automation and control on the shop floor; laboratory automation, data acquisition, and information management; quality workflow management; manufacturing execution; distribution; shipping; enterprise resource planning, interfaces for cross-system integration and IT infrastructure supporting a diverse technical computing environment. 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.


Practical Implementation of Process Validation Lifecycle Approach

24-26 Jun 2019

This classroom course is relevant to individuals working throughout the pharmaceutical product lifecycle in development, manufacturing, quality, and many other roles involved in validation of products and processes. It will help you integrate and link the science and risk-based lifecycle approach for Process Validation to your overall Pharmaceutical Quality System. It will provide you with practical application of quality risk management tools in preparation and planning for validation of your manufacturing control strategy. It will deliver statistical approaches and tools which can be used to strengthen and justify your decision-making rationale for defendable process design and process performance. 

Learn More & Register

Instructor

Jefferey Jones, Executive Director of Quality at Humacyte, Inc., has over 20 years of experience with development-stage and commercial biopharmaceutical process technology transfer. In his current role, Jefferey oversees Quality aspects of facility, process, and instrumentation design and scale up for a novel biologic process manufacturing bioengineered blood vessels. Prior to his work at Humacyte, Jefferey was responsible for Manufacturing Operations, Quality Assurance/Control, and Validation at Emergent Biodefense in Lansing, Michigan. Jefferey previously held positions overseeing Quality Assurance, Quality Control, and Product Development activities at MedImmune, Inc. and Human Genome Sciences. Jefferey earned a Bachelor of Science degree in Biology from Virginia Polytechnic Institute and State University and a Master of Science degree in Biotechnology from The Johns Hopkins University.  

Instructor

Tara Scherder has over 30 years of experience in the chemical and pharmaceutical industries as a statistician, process engineer, master black belt, and educator. She has functioned as both an in-house and external statistical consultant to drug substance and drug product teams across the product lifecycle for small and large molecule platforms. Tara’s formal education includes a BS degree in Chemical Engineering from the University of Pittsburgh and a MS degree in Statistics from Carnegie Mellon University. Her current passion as partner at SynoloStats is the implementation of statistical methods for lifecycle process validation, with a keen focus on business context and value.