GMP Fundamentals Bundle Series - Limited Offer

2025 ISPE April 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

Online Live Training Events

Process Validation
1 - 3 April 2025

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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Instructors

Director, Regulatory Compliance
Johnson & Johnson

GAMP® 5, Annex 11/Part 11 Basic Principles
7 - 9 April 2025

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.

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Instructor

Independent Consultant
GlaxoSmithKline PLC (Retired)

ATMP Manufacturing
7 - 10 April 2025

This new course is focused on the commercial manufacture of Advanced Therapy Medicinal Products (ATMPs) drug products in manufacturing facilities. The purpose of this course is to focus on facility engineering issues and how to provide cost-effective facilities to ensure that products of the highest quality are consistently manufactured, as defined in the new Good Practice Guide. This course stays at the facility level and establishes guiding principles from the GPG that should be considered during these emerging and rapidly evolving times. This course is written from the perspective of an allogeneic or autologous cellular therapy or gene-modified cellular therapy

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Instructor

Practice Leader: ATMPs & Biologics
Genesis AEC

Biopharmaceuticals: C&GT and ATMP
28 - 29 April 2025

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

Instructor

Practice Leader: ATMPs & Biologics
Genesis AEC