2021 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

GAMP® Basic Principles
1 - 2 Sep 2021

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, by building upon existing industry good practice in an efficient and effective manner.

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Instructor


Cleaning Validation Principles 
7 - 10 Sep 2021

This training 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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Instructor


Aseptic Processing & Annex 1 
13 - 16 Sep 2021

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

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Instructors


Biotechnology Manufacturing Facility Design
27 - 28 Sep 2021

This training course in biopharmaceutical manufacturing facility design provides an overview of the concepts utilized in the development and renovation of sound designs for facilities that manufacture biopharmaceutical products.

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Instructor


GMP Fundamentals for the Pharmaceutical Industry
28 - 29 Sep 2021

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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Instructor

Figen Yilmaz

General Manager
Figen Yilmaz Egitim Ve Danismanlik Ltd.Sti.

Overview Biopharmaceutical Manufacturing Processes
29 - 30 Sep 2021

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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Instructor


GAMP® 5, Annex 11/Part 11 Basic Principles
29 Sep - 1 Oct 2021

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.

Learn More & Register