In-Depth Pharma Training

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.   

Practical Implementation of Process Validation Lifecycle Approach

19 - 21 Sept

This 3-day course will define the requirements for preparation, planning and execution of Validation/Process Validation and how to maintain a state of control. It explores the 3 Stages of the validation product lifecycle, including Process Design, Equipment and Utility Qualification, establishing and implementing Process Performance Qualification (U.S.) or Process Validation (Europe) requirements, and putting in place an Ongoing/Continued Process Verification program. The course is applicable to all sectors of the pharmaceutical industry - small and large molecules, innovators and generics. The content comprises a blend of presentation of concepts and details, followed by related practice application scenarios/exercises.

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GAMP 5, Annex 11/Part 11 Basic Principles

24 - 26 Sept

This three-day 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. This course includes the revised EU GMP Annex 11 and an update on 21 CFR Part 11.

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