2020 ISPE May In-Depth Pharma Training Series

Deep Dive into 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.   

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.

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HVAC for Pharma Facilities
4 - 6 May 2020

This classroom course focuses on common issues and problems in the operation of a facility and maintaining readiness for cGMP inspection. Topics include control system alarm management, common system construction deficiencies, cGMP documentation, maintaining an "inspection ready" state, frequency of testing and balancing, airflow visualization, air change rate reduction and more.

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Norman A. Goldschmidt
President
Genesis Engineers Inc
Instructor

Norman Goldschmidt is President and Sr. Principal at Genesis Engineers. He has over 30 years of experience in engineering management, planning, design and construction in the pharmaceutical and biotech industry. Prior to joining Genesis, Norman served in numerous capacities during 20 years with Bristol-Myers Squibb (BMS). Starting as a Mechanical Engineer / Project Manager and culminating as Executive Director, Global Engineering for Strategy and Design. His industry experience spans the many types of facilities and processes necessary to bring a drug to market - from R&D through Manufacturing. 


Application of Engineering First Principles to Improve Manufacturing Operation in the Pharmaceutical Industry
7 - 8 May 2020

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.

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

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. He has held a variety of roles in process control and process engineering over this time, as well as time in corporate manufacturing.


Practical Application of Technology Transfer
14 - 15 May 2020

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.

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Jefferey Jones
Executive Director CMC Regulatory Affairs
Humacyte
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. 


Basic Principles of Computerized Systems Compliance using GAMP 5, Including Revised Annex 11 & Part 12 - Updated!
18 - 21 May 2020

This 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.

Instructor

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.