2022 ISPE September Online Live Training

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 eLearning

Aseptic Processing & Annex 1
1 - 2 Sep 2022

This course will focus on aseptic processing and quality management around the most important pharmaceutical technology.

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Instructors


Pharmaceutical Technology Transfer 
7 - 8 Sep 2022

This training 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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Instructors

John Henchion

Global Director for Quality, Compliance and Regulatory
CAI

Pharma Facilities Project Management
12 - 13 Sep 2022

This course is structured around a typical facility project lifecycle of Project Initiation, Delivery Planning, Design Planning and Delivery, Procurement, Construction, Commissioning and Qualification and Project Close-Out & Review and uses case study examples throughout to illustrate key points.

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Instructors


Process Validation
12 - 14 Sep 2022

Course participants will focus on the practical application of the lifecycle approach to all stages of PV to gain valuable knowledge and insight on the regulations, guidance, and best practices currently utilized across the industry. 

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Biopharmaceuticals: CMC Aspects
14 Sep 2022

The purpose of this course is to provide an advanced understanding of the CMC considerations of biopharmaceuticals from development to commercialization. An emphasis will be placed on using Quality by Design principles to develop, manufacture and guide the product lifecycle. Lastly, we will examine biosimilars and regulatory factors that affect product development and the product lifecycle and drug costs. View Dates What You Will Learn Overview of Biopharmaceutical Development Quality by Design Cell

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Pharma Water Generation USP WFI & Purified Water
19 - 22 Sep 2022

This online course has been substantially updated to feature the guiding principles of the ISPE Baseline Guide: Water and Steam Systems (Second Edition) with particular emphasis placed upon the new chapters for microbial control and laboratory water as well as key design philosophies

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Instructors


Overview Biopharmaceutical Manufacturing Processes
19 - 22 Sep 2022

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.

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Cleaning Validation Principles
20 - 23 Sep 2022

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.

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GMP Fundamentals for the Pharmaceutical Industry
22 - 23 Sep 2022

This course is designed to help participants understand the GMPs as they relate to the pharmaceutical industry. Participants will gather information about both European regulators and the FDA, how the various agencies enforce GMP requirements, and what to expect during a routine GMP inspection. They will examine and discuss the process of a regulatory inspection and gain valuable insight into the compliance auditing process.

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Instructors

John Henchion

Global Director for Quality, Compliance and Regulatory
CAI

GAMP® 5, Annex 11/Part 11 Basic Principles
28 - 30 Sep 2022

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. Please click the "Locations and Registrations" table to select the two or three-day sessions.

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