2020 ISPE June 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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Basic Principles of Computerized Systems Compliance using GAMP 5, Including Revised Annex 11 and Part 12 - Updated!
8 - 9 June 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.


Oral Solid Dosage Manufacturing Process Training Course
10 - 11 June 2020

This classroom course examines current technology and provides scenario-based exercises for system troubleshooting and investigational events for process deviations, discusses quality management and GMP inspection preparation, and provides guidance on advanced asset lifecycle management strategy.

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Jack C. Chu, PE
Senior Consultant- Special Products
CAI
Instructor

Jack Chu has more than (30) years business experiences in Bio-pharm and Life Sciences Industries. After about (25) year services at Merck, Jack joined CAI (Commissioning Agents, Inc.) as Senior Consultant in 2017. Jack Chu is a licensed Professional Engineer. He has designed and implemented many significant projects worldwide since 1985. Jack also successfully led professional teams as expert witness for many complicated legal cases relating to engineering, technology, and operational issues. 


 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)
15 - 16 June 2020

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.

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John T. Hannon, PE, CPIP
Global Automation & IT Lead
CAI
Instructor

John Hannon is an Executive Consultant and Business Area Leader for Automation and IT at Commissioning Agents. With over 27 years in the pharmaceutical, IT, and process automation fields, he has been instrumental in starting up cutting-edge biotech facilities for companies such as Baxter, Monsanto, Amgen, Genentech, Wyeth, and Cook. In the past, he has managed multi-million dollar projects along with dozens of client managers across the Southeastern US, responsible for delivering hundreds of high-profile, mission-critical projects for biotech, pharmaceutical, and medical device customers.